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		<title>How Zasio Delivers Industry Best Recordkeeping Research</title>
		<link>https://zasio.com/how-zasio-delivers-industry-best-recordkeeping-research/</link>
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		<dc:creator><![CDATA[Zasio]]></dc:creator>
		<pubDate>Tue, 14 Jan 2025 16:00:44 +0000</pubDate>
				<category><![CDATA[Blog]]></category>
		<category><![CDATA[By Jake Naylor]]></category>
		<category><![CDATA[recordkeeping]]></category>
		<category><![CDATA[Research]]></category>
		<category><![CDATA[Zasio]]></category>
		<guid isPermaLink="false">https://wptest.zasio.com/?p=2758</guid>

					<description><![CDATA[<p>By Jake Naylor — Zasio Analyst Ever wonder why Zasio’s research team leads the industry? They are more than just proficient legal researchers—they immerse themselves in record keeping. Collaboration with Zasio’s consulting and technology teams results in accurate, in-depth, and top-quality records management solutions. Our clients receive a product focused on relevant recordkeeping requirements vetted alongside business best practices. Customer success is our sole objective, and our expertise and qualifications provide high-quality research for recordkeeping unmatched by our competitors. Zasio Researchers Have Over 65 Years of Combined Experience in Records Management And that’s not just years of career experience—that’s years with Zasio dedicated to recordkeeping regulation. Most of our researchers are attorneys and paralegals who understand the nuances of international recordkeeping law. Our researchers’ refined methodologies have been proven over years spent successfully developing projects in numerous industries and ensure our clients receive the most thoroughly vetted research for their business needs. Our researchers use their experience to focus exclusively on citations relevant to each client’s specific business processes. Through this consistent approach, we avoid the predictable dead ends other recordkeeping consulting firms encounter. Record Keeping Specialization Fluency in the language of recordkeeping takes time. Statutes and regulations obscure retention [&#8230;]</p>
<p>The post <a href="https://zasio.com/how-zasio-delivers-industry-best-recordkeeping-research/" data-wpel-link="internal">How Zasio Delivers Industry Best Recordkeeping Research</a> appeared first on <a href="https://zasio.com" data-wpel-link="internal">Zasio</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><em>By Jake Naylor — Zasio Analyst</em></p>
<p>Ever wonder why Zasio’s research team leads the industry? They are more than just proficient legal researchers—they immerse themselves in record keeping. Collaboration with Zasio’s consulting and technology teams results in accurate, in-depth, and top-quality <a href="https://zasio.com/" data-wpel-link="internal">records management solutions</a>. Our clients receive a product focused on relevant recordkeeping requirements vetted alongside business best practices. Customer success is our sole objective, and our expertise and qualifications provide high-quality research for recordkeeping unmatched by our competitors.</p>
<p><strong>Zasio Researchers Have Over 65 Years of Combined Experience in Records Management</strong></p>
<p>And that’s not just years of career experience—that’s years with Zasio dedicated to recordkeeping regulation. Most of our researchers are attorneys and paralegals who understand the nuances of international recordkeeping law. Our researchers’ refined methodologies have been proven over years spent successfully developing projects in numerous industries and ensure our clients receive the most thoroughly vetted research for their business needs. Our researchers use their experience to focus exclusively on citations relevant to each client’s specific business processes. Through this consistent approach, we avoid the predictable dead ends other recordkeeping consulting firms encounter.</p>
<p><strong>Record Keeping Specialization</strong></p>
<p>Fluency in the language of recordkeeping takes time. Statutes and regulations obscure retention periods, triggers, and format requirements. Our team members have specific industry certifications related to recordkeeping—such as Certified Records Manager (CRM), Information Governance Professional (IGP), Certified Information Privacy Professional (CIPP), and Certified Information Privacy Manager—which anchor their efforts in industry practice. In addition to client recordkeeping projects, Zasio researchers work year-round to keep citations in Zasio’s world-class database up to date. We monitor trends in privacy, retention, and handling restrictions. We comprehensively review—and re-review—all available primary and secondary sources. A singular focus on recordkeeping law allows Zasio’s research team to provide consistent and relevant results.</p>
<p><strong>Research Knowledge Base</strong></p>
<p>At Zasio, we know research without focus leads to unrefined results. It is critical to understand the context of citations to business practices. Our team uses research and consulting to maintain a fresh perspective on what records managers in various industries consider essential. Zasio’s researchers also benefit from interactions with our client’s stakeholders and legal counsel, apprising them of current business operations. This collaboration focuses their research on essential functions and practices. Zasio’s researchers work with our consultants to identify tricky citations and align them with industry common practice. We save our clients time and money by fostering a collaborative environment that streamlines the legal focus of recordkeeping research.</p>
<p><strong>Internal and Direct Resources</strong></p>
<p>A good team is left blind without proper tools to harness and focus their skills. Zasio’s industry-leading <a href="https://zasio.com/technology-solutions/retention-schedule-management/" data-wpel-link="internal">records retention software platform</a> houses our coded pinpoint citations containing regulated parties and retention periods. However, our researchers don’t just use Zasio’s software to input citations but also work with our technology team to provide feedback and optimize the technology. Our researchers understand what information is relevant and provide input to ensure the end-user experience is refined and efficient.</p>
<p><strong>Not all Research is Created Equal</strong>.</p>
<p>Knowing the source of your vendor’s research is essential. A high-caliber research team provides a strong foundation for recordkeeping programs through accurate and customized recordkeeping citations. The experienced, focused, and dedicated Zasio team carries a distinct advantage by providing businesses with the precise information they need to meet recordkeeping challenges quickly and efficiently. Like names on film credits, those doing the challenging work are often not prominently recognized. But like those individuals supporting a successful film, Zasio’s researchers create the backbone for an effective and defensible recordkeeping strategy that would be impossible without their dedicated efforts.</p>
<p><em>Disclaimer: The purpose of this post is to provide general education on Information Governance topics. The statements are informational only and do not constitute legal advice. If you have specific questions regarding the application of the law to your business activities, you should seek the advice of your legal counsel.</em></p>
<p><a class="a2a_button_facebook" href="https://www.addtoany.com/add_to/facebook?linkurl=https%3A%2F%2Fzasio.com%2Fhow-zasio-delivers-industry-best-recordkeeping-research%2F&amp;linkname=How%20Zasio%20Delivers%20Industry%20Best%20Recordkeeping%20Research" title="Facebook" rel="nofollow noopener external noreferrer" target="_blank" data-wpel-link="external"></a><a class="a2a_button_x" href="https://www.addtoany.com/add_to/x?linkurl=https%3A%2F%2Fzasio.com%2Fhow-zasio-delivers-industry-best-recordkeeping-research%2F&amp;linkname=How%20Zasio%20Delivers%20Industry%20Best%20Recordkeeping%20Research" title="X" rel="nofollow noopener external noreferrer" target="_blank" data-wpel-link="external"></a><a class="a2a_button_linkedin" href="https://www.addtoany.com/add_to/linkedin?linkurl=https%3A%2F%2Fzasio.com%2Fhow-zasio-delivers-industry-best-recordkeeping-research%2F&amp;linkname=How%20Zasio%20Delivers%20Industry%20Best%20Recordkeeping%20Research" title="LinkedIn" rel="nofollow noopener external noreferrer" target="_blank" data-wpel-link="external"></a><a class="a2a_dd addtoany_share_save addtoany_share" href="https://www.addtoany.com/share#url=https%3A%2F%2Fzasio.com%2Fhow-zasio-delivers-industry-best-recordkeeping-research%2F&#038;title=How%20Zasio%20Delivers%20Industry%20Best%20Recordkeeping%20Research" data-a2a-url="https://zasio.com/how-zasio-delivers-industry-best-recordkeeping-research/" data-a2a-title="How Zasio Delivers Industry Best Recordkeeping Research" data-wpel-link="external" rel="external noopener noreferrer"></a></p><p>The post <a href="https://zasio.com/how-zasio-delivers-industry-best-recordkeeping-research/" data-wpel-link="internal">How Zasio Delivers Industry Best Recordkeeping Research</a> appeared first on <a href="https://zasio.com" data-wpel-link="internal">Zasio</a>.</p>
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		<title>Recordkeeping Basics: Managing Your Accounting Records</title>
		<link>https://zasio.com/recordkeeping-basics-managing-your-accounting-records/</link>
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		<dc:creator><![CDATA[Zasio]]></dc:creator>
		<pubDate>Fri, 07 May 2021 20:56:19 +0000</pubDate>
				<category><![CDATA[Blog]]></category>
		<category><![CDATA[By Heather Houle]]></category>
		<category><![CDATA[Heather Houle]]></category>
		<category><![CDATA[information governance]]></category>
		<category><![CDATA[information management]]></category>
		<category><![CDATA[recordkeeping]]></category>
		<category><![CDATA[records management]]></category>
		<guid isPermaLink="false">https://wordpress-140425-3498808.cloudwaysapps.com/?p=540</guid>

					<description><![CDATA[<p>The post <a href="https://zasio.com/recordkeeping-basics-managing-your-accounting-records/" data-wpel-link="internal">Recordkeeping Basics: Managing Your Accounting Records</a> appeared first on <a href="https://zasio.com" data-wpel-link="internal">Zasio</a>.</p>
]]></description>
										<content:encoded><![CDATA[<div class="et_pb_section et_pb_section_0 et_section_regular" >
				
				
				
				
				
				
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				<div class="et_pb_text_inner">It is that time of year again! Time to look at your retention schedule and decide what needs to be organized. It is a love-hate relationship for some. Most organizations have filed taxes for 2020, making this a great time of year to think about whether older accounting records may no longer be subject to any retention requirements.</p>
<p>Everyone knows how important it is to balance your company books, but where do you even start? Start by determining what accounting documents you have and what your record retention requirements are. All businesses are required to keep accounting documents for certain lengths of time. Keeping your accounting records organized can save you time, money, and headaches every tax season.</p>
<p><strong>What Documents Are Considered Accounting Documents?</strong></p>
<p>Accounting documents describe a business’s transactions. Examples include general ledgers, bank statements, invoices, inventories, and receipts. Accounting documents are important for business and operational needs, but they are vital for audits.</p>
<p><strong>U.S. Governmental Agency Accounting Documents.</strong></p>
<p>If you are a U.S. governmental agency, the Internal Revenue Service (IRS) has adopted the General Records Schedules (GRS), which contain disposition instructions for administrative functions common to most offices. The GRS recommends businesses keep “financial transaction records related to procuring goods and services, paying bills, collecting debts, and accounting” and to “destroy six years after final payment or cancellation, but longer retention is authorized if required for business use.” <a href="https://www.zasio.com/recordkeeping-basics-managing-your-accounting-records/#_edn1" name="_ednref1" data-wpel-link="internal">[i]</a>  Regarding an audit, the “IRS can include returns filed within the last three years . . .  If we identify a substantial error, we may add additional years. We usually don’t go back more than the last six years. <a href="https://www.zasio.com/recordkeeping-basics-managing-your-accounting-records/#_edn2" name="_ednref2" data-wpel-link="internal"><sup>[ii]</sup></a></p>
<p><strong>Accounting Documents for U.S. Business Entities.</strong></p>
<p>If you are a business operating in the United States, retention requirements will differ depending on which state[s] you operate in. Many U.S. companies adopt the retention requirement found in California’s 18 CCR 19141.6, which states:</p>
<p>Records for any year must be retained for the longer of: the time during which the taxpayer’s franchise or income tax is subject to adjustment but not to exceed eight years from the due date or extended due date of return.</p>
<p><strong>Accounting Documents for International Entities.</strong></p>
<p>If your business has a presence in different countries, you could be looking at longer retention periods for accounting documents. To determine retention requirements among multiple countries, ARMA International has put together the <a href="https://magazine.arma.org/2019/11/summary-retention-of-accounting-records-a-global-survey-of-laws-and-regulations/" data-wpel-link="external" rel="external noopener noreferrer"><em>Retention of Accounting Records: A Global Survey of Laws and Regulation</em><em>s</em></a>, a summary of several countries, and their accounting retention requirements. On average, retention periods for accounting documents range from 3 to 10 years. Some companies increase these retention periods to 11 or 12 years to account for fiscal year requirements on top of the applicable base retention period. You will also want to research whether applicable countries have any archival order laws, as these can further increase accounting record retention periods. For example, Poland, Slovenia, and China have archival order laws that create significantly longer accounting record retention requirements.</p>
<p>Now is the right time of year to go through your business accounting records and dispose of any documents not required for legal, business operational, and practical storage needs. Your business will need to weigh the cost of keeping information that is no longer necessary for business operational needs to prevent potential litigation problems.</p>
<p>Are you unsure of which documents you can dispose of? If so, <a href="https://www.zasio.com/about-us/contact-us/" data-wpel-link="internal">contact Zasio</a> to assist you in identifying gaps in your retention schedule and answer any accounting record retention questions.</p>
<p><a href="https://www.zasio.com/recordkeeping-basics-managing-your-accounting-records/#_ednref1" name="_edn1" data-wpel-link="internal">[i]</a> <a href="https://www.irs.gov/pub/irs-utl/d12829.pdf" data-wpel-link="external" rel="external noopener noreferrer">https://www.irs.gov/pub/irs-utl/d12829.pdf</a></p>
<p><a href="https://www.zasio.com/recordkeeping-basics-managing-your-accounting-records/#_ednref2" name="_edn2" data-wpel-link="internal">[ii]</a> <a href="https://www.irs.gov/businesses/small-businesses-self-employed/irs-audits#:~:text=Generally%2C%20the%20IRS%20can%20include,possible%20after%20they%20are%20filed" data-wpel-link="external" rel="external noopener noreferrer">https://www.irs.gov/businesses/small-businesses-self-employed/irs-audits#:~:text=Generally%2C%20the%20IRS%20can%20include,possible%20after%20they%20are%20filed</a>.</p>
<p>&nbsp;</p>
<p><em>Disclaimer: The purpose of this post is to provide general education on Information Governance topics. The statements are informational only and do not constitute legal advice. If you have specific questions regarding the application of the law to your business activities, you should seek the advice of your legal counsel.</em></div>
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				<div class="et_pb_team_member_image et-waypoint et_pb_animation_off"><img decoding="async" width="96" height="96" src="https://zasio.com/wp-content/uploads/2022/01/Heather-Houle-01-96x96-1.jpg" alt="Author: Heather Houle, CRA" class="wp-image-2067" /></div>
				<div class="et_pb_team_member_description">
					<h4 class="et_pb_module_header">Author: Heather Houle, CRA</h4>
					<p class="et_pb_member_position">Senior Research Analyst / Certified Paralegal</p>
					
					
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<p><a class="a2a_button_facebook" href="https://www.addtoany.com/add_to/facebook?linkurl=https%3A%2F%2Fzasio.com%2Frecordkeeping-basics-managing-your-accounting-records%2F&amp;linkname=Recordkeeping%20Basics%3A%20Managing%20Your%20Accounting%20Records" title="Facebook" rel="nofollow noopener external noreferrer" target="_blank" data-wpel-link="external"></a><a class="a2a_button_x" href="https://www.addtoany.com/add_to/x?linkurl=https%3A%2F%2Fzasio.com%2Frecordkeeping-basics-managing-your-accounting-records%2F&amp;linkname=Recordkeeping%20Basics%3A%20Managing%20Your%20Accounting%20Records" title="X" rel="nofollow noopener external noreferrer" target="_blank" data-wpel-link="external"></a><a class="a2a_button_linkedin" href="https://www.addtoany.com/add_to/linkedin?linkurl=https%3A%2F%2Fzasio.com%2Frecordkeeping-basics-managing-your-accounting-records%2F&amp;linkname=Recordkeeping%20Basics%3A%20Managing%20Your%20Accounting%20Records" title="LinkedIn" rel="nofollow noopener external noreferrer" target="_blank" data-wpel-link="external"></a><a class="a2a_dd addtoany_share_save addtoany_share" href="https://www.addtoany.com/share#url=https%3A%2F%2Fzasio.com%2Frecordkeeping-basics-managing-your-accounting-records%2F&#038;title=Recordkeeping%20Basics%3A%20Managing%20Your%20Accounting%20Records" data-a2a-url="https://zasio.com/recordkeeping-basics-managing-your-accounting-records/" data-a2a-title="Recordkeeping Basics: Managing Your Accounting Records" data-wpel-link="external" rel="external noopener noreferrer"></a></p><p>The post <a href="https://zasio.com/recordkeeping-basics-managing-your-accounting-records/" data-wpel-link="internal">Recordkeeping Basics: Managing Your Accounting Records</a> appeared first on <a href="https://zasio.com" data-wpel-link="internal">Zasio</a>.</p>
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		<item>
		<title>International Tax Record Retention Period by Country</title>
		<link>https://zasio.com/international-tax-record-roundup/</link>
					<comments>https://zasio.com/international-tax-record-roundup/#respond</comments>
		
		<dc:creator><![CDATA[Zasio]]></dc:creator>
		<pubDate>Tue, 04 May 2021 20:58:20 +0000</pubDate>
				<category><![CDATA[Blog]]></category>
		<category><![CDATA[By Jared Walker]]></category>
		<category><![CDATA[information governance]]></category>
		<category><![CDATA[Jared Walker]]></category>
		<category><![CDATA[recordkeeping]]></category>
		<category><![CDATA[recordkeeping requirements]]></category>
		<category><![CDATA[records and information management]]></category>
		<category><![CDATA[records management]]></category>
		<category><![CDATA[Tax Records]]></category>
		<guid isPermaLink="false">https://wordpress-140425-3498808.cloudwaysapps.com/?p=543</guid>

					<description><![CDATA[<p>The post <a href="https://zasio.com/international-tax-record-roundup/" data-wpel-link="internal">International Tax Record Retention Period by Country</a> appeared first on <a href="https://zasio.com" data-wpel-link="internal">Zasio</a>.</p>
]]></description>
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				<div class="et_pb_text_inner"><p>For US taxpayers, May 17 (Tax Day) is fast approaching, and the question is often asked – How long should I keep my tax records?</p>
<h2>Tax Record Retention Periods by Country</h2>
<p>Here is a brief rundown of required or recommended recordkeeping periods for income tax records in the United States and other jurisdictions worldwide.</p>
<table style="width: 100%; border-collapse: collapse; text-align: left; font-family: sans-serif;">
<thead>
<tr style="background-color: #f2f2f2; border-bottom: 2px solid #ccc;">
<th style="padding: 10px; font-weight: bold;">Country</th>
<th style="padding: 10px; font-weight: bold;">Retention Period</th>
<th style="padding: 10px; font-weight: bold;">Special Conditions / Notes</th>
</tr>
</thead>
<tbody>
<tr style="border-bottom: 1px solid #eee;">
<td style="padding: 10px; font-weight: bold;">Brazil</td>
<td style="padding: 10px;">5 years</td>
<td style="padding: 10px;">Mirrors the standard tax limitation period.</td>
</tr>
<tr style="border-bottom: 1px solid #eee;">
<td style="padding: 10px; font-weight: bold;">Canada</td>
<td style="padding: 10px;">6 years</td>
<td style="padding: 10px;">Starts after the end of the tax year to which they relate.</td>
</tr>
<tr style="border-bottom: 1px solid #eee;">
<td style="padding: 10px; font-weight: bold;">China</td>
<td style="padding: 10px;">10 years</td>
<td style="padding: 10px;">Unless otherwise stipulated in specific laws or regulations.</td>
</tr>
<tr style="border-bottom: 1px solid #eee;">
<td style="padding: 10px; font-weight: bold;">France</td>
<td style="padding: 10px;">6 to 10 years</td>
<td style="padding: 10px;">Standard period is 6 years, but extends to 10 years for certain transactions.</td>
</tr>
<tr style="border-bottom: 1px solid #eee;">
<td style="padding: 10px; font-weight: bold;">Germany</td>
<td style="padding: 10px;">6 to 10 years</td>
<td style="padding: 10px;"><strong>6 years</strong> for business letters and general tax documents; <strong>10 years</strong> for accounting records, inventories, and balance sheets.</td>
</tr>
<tr style="border-bottom: 1px solid #eee;">
<td style="padding: 10px; font-weight: bold;">India</td>
<td style="padding: 10px;">6 years</td>
<td style="padding: 10px;">Starts from the end of the relevant assessment year.</td>
</tr>
<tr style="border-bottom: 1px solid #eee;">
<td style="padding: 10px; font-weight: bold;">Japan</td>
<td style="padding: 10px;">7 to 10 years</td>
<td style="padding: 10px;"><strong>7 years</strong> generally for individuals and companies under tax law; <strong>10 years</strong> for corporate records required by the Companies Act.</td>
</tr>
<tr style="border-bottom: 1px solid #eee;">
<td style="padding: 10px; font-weight: bold;">Mexico</td>
<td style="padding: 10px;">5 years</td>
<td style="padding: 10px;">Starts from the date taxes were filed or due.</td>
</tr>
<tr style="border-bottom: 1px solid #eee;">
<td style="padding: 10px; font-weight: bold;">United Kingdom</td>
<td style="padding: 10px;">22 months to 6 years</td>
<td style="padding: 10px;"><strong>22 months</strong> from the end of the tax year for individuals; <strong>5 years</strong> from January 31 following the tax year for self-employed/partnerships; <strong>6 years</strong> from the end of the accounting period for companies.</td>
</tr>
<tr style="border-bottom: 1px solid #eee;">
<td style="padding: 10px; font-weight: bold;">United States</td>
<td style="padding: 10px;">3 to 7 years</td>
<td style="padding: 10px;">General IRS suggestion starts at <strong>3 years</strong>, fluctuating up to <strong>7 years</strong> (or indefinitely) depending on fraud, substantial errors, or specific credit circumstances.</td>
</tr>
</tbody>
</table>
<p>These time periods do not account for business needs, industry practice, or other legal requirements or exceptions applying to various tax-related records that could potentially increase the required time to keep such records.</p>
<h3>United States Tax Record Retention Period:</h3>
<p>As we have <a href="https://www.zasio.com/tax-season-record-keeping/" target="_blank" rel="noopener" data-wpel-link="internal">previously discussed,</a> the general IRS-suggested records retention period for US citizens starts at three years, and fluctuates to up to seven years (and in some cases, indefinitely), depending on various circumstances and limitation periods.</p>
<p><a href="https://www.irs.gov/businesses/small-businesses-self-employed/how-long-should-i-keep-records#:~:text=Keep%20records%20for%203%20years%20from%20the%20date%20you%20filed,securities%20or%20bad%20debt%20deduction.%20Canada:" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">Source</a></p>
<h3>Canada Tax Record Retention Period:</h3>
<p>Keep supporting tax documents for six years after the end of the tax year to which they relate.</p>
<p><a href="https://www.canada.ca/en/revenue-agency/services/tax/individuals/topics/about-your-tax-return/long-should-you-keep-your-income-tax-records.html" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">Source</a></p>
<h3>Mexico Tax Record Retention Period:</h3>
<p>Keep tax and accounting records five years from the date taxes were filed or due.</p>
<p><a href="http://www.diputados.gob.mx/LeyesBiblio/ref/cff.htm" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">Source</a></p>
<h3>United Kingdom Tax Record Retention Period:</h3>
<p><em>Individuals (not carrying on a business</em>): keep records for 22 months from the end of the tax year to which the records relate.</p>
<p><em>Self-employed or in a partnership</em>: keep records for at least five years from 31 January following the tax year to which the return relates.</p>
<p><em>Companies</em>: typically, accounting records must be kept for six years from the end of the accounting period.</p>
<p><a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/377656/rk-bk1.pdf" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">Source</a></p>
<h3>Japan Tax Record Retention Period:</h3>
<p><em>Individuals (Under the Income Tax Act</em>): generally need to keep tax records for seven years, but some documents may be stored for five years. Companies also will need to store tax and accounting records for seven years, but the Companies Act requires records to be kept for ten years, regardless of tax law requirements.</p>
<p><a href="https://j-net21.smrj.go.jp/accounts/tax/20140329_04.html%20Brazil:" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">Source</a></p>
<h3>Brazil Tax Record Retention Period:</h3>
<p>Tax records are to be kept for a general period of five years, which mirrors the standard tax limitation period.</p>
<p><a href="http://www.planalto.gov.br/ccivil_03/_Ato2015-2018/2018/Decreto/D9580.htm" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">Source</a></p>
<h3>Germany Tax Record Retention Period:</h3>
<p>Generally, taxpayers need to keep accounting and tax-related records for six years (trade or business letters sent or received, other relevant tax-related documents) or ten years (accounting records, inventories, annual financial statements, opening balance sheets, etc.).</p>
<p>Source: <a href="https://www.gesetze-im-internet.de/englisch_ao/" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">Fiscal Code of Germany  </a></p>
<h3>India Tax Record Retention Period:</h3>
<p>Accounting and tax-related records for people in a variety of professions are to be kept for six years from the end of the relevant assessment year.</p>
<p>Source:<a href="https://incometaxindia.gov.in/Pages/rules/income-tax-rules-1962.aspx" target="_blank" rel="noopener external noreferrer" data-wpel-link="external"> Income Tax Rules, Rule 6F </a></p>
<h3>France Tax Record Retention Period:</h3>
<p>Tax records must be kept for six years, with records of certain transactions to be kept for ten years.</p>
<p><a href="https://www.economie.gouv.fr/entreprises/delai-conservation-documents#" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">Source</a></p>
<h3>China Tax Record Retention Period:</h3>
<p>Accounting and tax records need to be kept for ten years, except as otherwise stipulated in other laws or regulations.</p>
<p><a href="http://www.china.org.cn/business/laws_regulations/2007-06/22/content_1214799.htm" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">Source</a></p>
<p>It is wise to carefully consider the tax laws, regulations, and recordkeeping requirements in your jurisdiction to make sure you remain legally compliant and prepared for audits or other circumstances requiring access to these records. Proper recordkeeping along with <a href="https://zasio.com/technology-solutions/retention-schedule-management/" data-wpel-link="internal">advanced records retention software</a> helps to avoid possible legal, compliance, or other issues down the road.</p>
<p><a href="https://www.zasio.com/about-us/contact-us/" target="_blank" rel="noopener" data-wpel-link="internal">Contact Zasio</a> today to see how our innovative products and services can meet your <a href="https://zasio.com/technology-solutions/" data-wpel-link="internal">recordkeeping and information governance software</a> needs.</p>
<p>&nbsp;</p>
<p><em>Disclaimer: The purpose of this post is to provide general education on Information Governance topics. The statements are informational only and do not constitute legal advice. If you have specific questions regarding the application of the law to your business activities, you should seek the advice of your legal counsel.</em></p></div>
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		<title>Wait, Is That a COVID-19 Record?</title>
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		<pubDate>Mon, 22 Feb 2021 21:22:41 +0000</pubDate>
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		<category><![CDATA[By Jennifer Chadband]]></category>
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					<description><![CDATA[<p>The post <a href="https://zasio.com/wait-is-that-a-covid-19-record/" data-wpel-link="internal">Wait, Is That a COVID-19 Record?</a> appeared first on <a href="https://zasio.com" data-wpel-link="internal">Zasio</a>.</p>
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										<content:encoded><![CDATA[<div class="et_pb_section et_pb_section_2 et_section_regular" >
				
				
				
				
				
				
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				<div class="et_pb_text_inner">It’s no surprise that a global pandemic has created a lot of records, along with many questions surrounding these records. As organizations adapt to the new and constantly changing COVID-19 landscape, new processes and record outputs abound. We often get questions from our clients asking “is this a COVID-19 record?” and if yes, “how long should we be keeping this record?” Explicit authorities on company recordkeeping obligations have been slow to trickle down and are a bit of a patchwork with federal and state guidance provided only here and there.</p>
<p>This blog surveys a few of the common recordkeeping questions we’ve received and provides guidance on addressing COVID-19 records within your records retention schedule.</p>
<p><strong>Is a confirmed COVID-19 case recordable?</strong></p>
<p>Answer:  Maybe.</p>
<p><strong><em>For U.S. Organizations:</em></strong></p>
<p>The U.S. Occupational Safety and Health Administration (OSHA) has clarified that COVID-19 may be a recordable illness for covered employers if a worker is infected as a result of performing their work-related duties. This seems straightforward enough, but there are various criteria to determine whether the illness is recordable. For COVID-19 to be a recordable illness, the following must be met:</p>
<ol>
<li>The case must be a confirmed case of COVID-19. Per the Centers for Disease Control (CDC), a confirmed COVID-19 case means laboratory confirmation of an individual’s test, with at least one respiratory specimen that has tested positive for SARSCoV-2, the virus that causes COVID-19.<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn1" name="_ftnref1" data-wpel-link="internal">[1]</a></li>
<li>The case must be work-related as determined by a work-related analysis which includes a number of questions designed to determine whether the case is likely work-related;<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn2" name="_ftnref2" data-wpel-link="internal">[2]</a> This analysis is important since only work-related illnesses must be recorded and reported to OSHA.<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn3" name="_ftnref3" data-wpel-link="internal">[3]</a></li>
<li>The instance involves one or more of the general recording criteria including medical treatment beyond first aid or considering the employee’s number of days away from work. OSHA’s definition of a recordable illness includes “both acute and chronic illnesses, such as, but not limited to, a skin disease, respiratory disorder or poisoning.” This definition is limited to abnormal conditions or disorders that exclude the common cold and the seasonal flu.<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn4" name="_ftnref4" data-wpel-link="internal">[4]</a></li>
</ol>
<p>By OSHA’s own admission, arriving at a work-related determination can be difficult given the ubiquity of community spread.<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn5" name="_ftnref5" data-wpel-link="internal">[5]</a> Nonetheless, any recordable COVID-19 illnesses must be retained for a period of 5 years consistent with the OSHA 300 log recordkeeping requirement. Similarly, it would be prudent to keep the work-related analysis for the same period of time in case of an audit.<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn6" name="_ftnref6" data-wpel-link="internal">[6]</a></p>
<p><strong><em>But what about organizations with international operations?</em></strong></p>
<p>Organizations with international operations should consult jurisdiction-specific requirements. Research specific to the jurisdictions of your company’s operations is prudent to ensure appropriate retention periods are consulted as well as restrictions on the collection and retention of this class of employee health information. For example, the French CNIL prohibits employers from storing files related to information collected during automated processing of temperature screening of employees. However, CNIL states that the “data protection law does not apply to manual verification of temperatures where no information is retained.”<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn7" name="_ftnref7" data-wpel-link="internal">[7]</a></p>
<p><strong>How long do we need to keep temperature checks of employees taken for building entry purposes?</strong></p>
<p>Answer: Possibly as long as the duration of employment plus 30 years if it meets the definition of a medical record, but a much shorter duration if not.</p>
<p>Employee temperature checks are not usually permitted, but exceptions have been made during the pandemic. Per Equal Employment Opportunity Commission (EEOC) guidelines, employee temperature checks are permitted to determine whether an employee should be excluded from the workplace in the interest of public health.<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn8" name="_ftnref8" data-wpel-link="internal">[8]</a> Temperature checks may constitute a medical record,<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn9" name="_ftnref9" data-wpel-link="internal">[9]</a> and thus be subject to a 30-year retention period.<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn10" name="_ftnref10" data-wpel-link="internal">[10]</a> The definition of an employee medical record under OSHA is very particular:</p>
<p><em>[A] record concerning the health status of an employee that is made or maintained by a physician, nurse or other healthcare personnel, or technician, including medical and employment questionnaires or histories, the results of medical exams, lab test results, medical opinions/doctor’s recommendations, first aid records, employee medical complaints, and descriptions of treatment or prescriptions.<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn11" name="_ftnref11" data-wpel-link="internal"><strong>[11]</strong></a></em></p>
<p>If this information is collected by an individual that doesn’t meet the above criteria, then it is unclear whether it constitutes a medical record subject to a 30-year retention period.<a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftn12" name="_ftnref12" data-wpel-link="internal">[12]</a></p>
<p><strong>Privacy Considerations</strong></p>
<p>Determining the appropriate retention period for any COVID-19 related record is important for a number of reasons, including privacy considerations. Given the sensitive nature of health information, employers often minimize the amount of health information they collect. For example, when collecting employee health questionnaires, rather than record an employee’s temperature, employers may record a “yes” or “no” response to the question of whether the temperature meets the threshold for a fever.</p>
<p>Zasio recommends minimizing or even eliminating the amount of personal information an employer collects in proportion to the purpose for which it is collected. If collecting information constituting an employee’s medical record is unnecessary, then collecting a minimal amount of information may be considered more transitory in nature.</p>
<p><strong>Conclusion</strong></p>
<p>The advent of COVID-19 records presents an opportunity for us in the records and information management industry to put our skills to the test. Determining how to categorize these records and assessing the appropriate retention period requires an analysis of a number of factors; it is important to consider the business process(es) associated with the records, the purpose for which the record was created or is needed, business and operational considerations, along with an understanding of the relevant laws and regulations, including privacy. To top it off, organizations grapple with the potential of long-term risks and this certainly plays a part in how COVID-19 related records are being maintained.</p>
<p>For guidance and assistance navigating the complexities of your organization’s COVID-19 related records, please <a href="https://www.zasio.com/about-us/contact-us/" data-wpel-link="internal">contact Zasio</a> for assistance.</p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref1" name="_ftn1" data-wpel-link="internal">[1]</a> <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html" data-wpel-link="external" rel="external noopener noreferrer">https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html</a></p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref2" name="_ftn2" data-wpel-link="internal">[2]</a> <a href="https://www.osha.gov/memos/2020-05-19/revised-enforcement-guidance-recording-cases-coronavirus-disease-2019-covid-19#_ftn4" data-wpel-link="external" rel="external noopener noreferrer">https://www.osha.gov/memos/2020-05-19/revised-enforcement-guidance-recording-cases-coronavirus-disease-2019-covid-19#_ftn4</a></p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref3" name="_ftn3" data-wpel-link="internal">[3]</a> 29 CFR 1904.4</p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref4" name="_ftn4" data-wpel-link="internal">[4]</a> 29 CFR 1904.7</p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref5" name="_ftn5" data-wpel-link="internal">[5]</a> See Occupational Safety and Health Administration, May 19, 2020 Memorandum for Regional Administrators State Plan Designees, accessed at: https://www.osha.gov/memos/2020-05-19/revised-enforcement-guidance-recording-cases-coronavirus-disease-2019-covid-19</p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref6" name="_ftn6" data-wpel-link="internal">[6]</a> 29 CFR 1904.30</p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref7" name="_ftn7" data-wpel-link="internal">[7]</a> https://www.dataguidance.com/opinion/france-cnil-issues-guidance-employers-personal-data-collection-during-coronavirus-lockdown</p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref8" name="_ftn8" data-wpel-link="internal">[8]</a> <a href="https://www.eeoc.gov/laws/guidance/pandemic-preparedness-workplace-and-americans-disabilities-act#q7" data-wpel-link="external" rel="external noopener noreferrer">https://www.eeoc.gov/laws/guidance/pandemic-preparedness-workplace-and-americans-disabilities-act#q7</a></p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref9" name="_ftn9" data-wpel-link="internal">[9]</a> 1910.1020(c)(6)</p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref10" name="_ftn10" data-wpel-link="internal">[10]</a> 1910.1020(d)(1)(i)</p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref11" name="_ftn11" data-wpel-link="internal">[11]</a> https://www.osha.gov/sites/default/files/publications/OSHA4045.pdf</p>
<p><a href="https://www.zasio.com/wait-is-that-a-covid-19-record/#_ftnref12" name="_ftn12" data-wpel-link="internal">[12]</a> <em>Id</em>.</p>
<p><em>Disclaimer: The purpose of this post is to provide general education on Information Governance topics. The statements are informational only and do not constitute legal advice. If you have specific questions regarding the application of the law to your business activities, you should seek the advice of your legal counsel.</em></div>
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		<title>“You’ve Got Mail” — Issues. Management and Retention of Email</title>
		<link>https://zasio.com/issues-management-retention-email/</link>
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		<pubDate>Fri, 02 Oct 2020 21:54:19 +0000</pubDate>
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		<category><![CDATA[data management]]></category>
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		<category><![CDATA[records and information management]]></category>
		<category><![CDATA[retention email]]></category>
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					<description><![CDATA[<p>The question of how to deal with email is a common vexation among records managers and information technology directors – the exasperation it causes being right up there with herding cats. Effectively managing email is usually somewhere “on the list” of items to take care of, but rarely at the top. As a result, employees are often left to fend for themselves regarding how to manage their email records, most often outside the scope of data retention and information governance policies. This can bring rise to issues over data security, privacy, discovery, and cyber-theft. Most users want direction in this area to protect both themselves and the organization. But, this direction will only remain welcome if it’s not difficult to administer or overly complicated. Let’s take a look at some common approaches, pitfalls, and recommendations to get you started. Email is Not Dead Yet With the rise of so many instant messaging and collaboration apps like Slack and Teams, one might think email is not that big of an issue in 2020. In fact, According to HubSpot, 86 percent of business professionals prefer to use email when communicating for business purposes. Fifty nine percent of B2B marketers say email is their [&#8230;]</p>
<p>The post <a href="https://zasio.com/issues-management-retention-email/" data-wpel-link="internal">“You’ve Got Mail” — Issues. Management and Retention of Email</a> appeared first on <a href="https://zasio.com" data-wpel-link="internal">Zasio</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>The question of how to deal with email is a common vexation among records managers and information technology directors – the exasperation it causes being right up there with herding cats.</p>
<p>Effectively managing email is usually somewhere “on the list” of items to take care of, but rarely at the top. As a result, employees are often left to fend for themselves regarding how to manage their email records, most often outside the scope of data retention and information governance policies. This can bring rise to issues over data security, privacy, discovery, and cyber-theft. Most users want direction in this area to protect both themselves and the organization. But, this direction will only remain welcome if it’s not difficult to administer or overly complicated. Let’s take a look at some common approaches, pitfalls, and recommendations to get you started.</p>
<p><strong>Email is Not Dead Yet</strong></p>
<p>With the rise of so many instant messaging and collaboration apps like Slack and Teams, one might think email is not that big of an issue in 2020. In fact, <a href="https://www.hubspot.com/marketing-statistics" data-wpel-link="external" rel="external noopener noreferrer">According to HubSpot</a>, 86 percent of business professionals prefer to use email when communicating for business purposes. Fifty nine percent of B2B marketers say email is their most effective channel for revenue generation. And 80 percent of retail professionals indicate that email marketing is their greatest driver of customer retention. While social media may get the headlines, email still is the foundation of business communication today.</p>
<blockquote><p><strong><em>80% of retail professionals indicate that email marketing is their greatest driver of customer retention</em></strong><strong><em>.</em></strong></p></blockquote>
<p><strong>Common Approaches</strong></p>
<p>In our work with various organizations across all industries we have found there are just a few common approaches to this problem of governing email. After the brief review of these below, we will discuss some of the issues with these methods, and also how they might be used in a more comprehensive approach.</p>
<ul>
<li><em>Do Nothing</em> – you may be laughing but this is often the default action with regard to managing email retention and disposition. The practice may be justified by stating that emails represent transitory information, and therefore are not records. Most legal experts disagree with this argument, however.</li>
<li><em>Safety Net</em> – this involves setting up an email vault to capture all email at the server level and keep it for a set period of time, usually between one and five years, just in case something is needed for legal reasons. This default ”just-in-case” retention period is more for those who are worried about losing an important email than being found with one.</li>
<li><em>Quotas/Short Term Retention</em> – in this scenario a combination of company policy and technical configuration sets limits on how much email a user can store in their inbox, either based on storage space, or the age of emails. For example, one might be limited to 2 GB of data, or nothing older than 6 months. This practice forces users to purge old emails to free up space, or automatically removes old emails, thus encouraging important items to be saved elsewhere.</li>
<li><em>Purge Days</em> – following the often-used practice for physical records, specific days on the calendar are set aside for all employees to manually comb through emails and delete what’s not important.</li>
<li><em>Capstone</em> – many government agencies follow the Capstone Approach, whereby all email for certain individuals is saved based on their role or title. The idea is that the most important information will bubble up to the top levels of the agency, thereby limiting the need to collect email from everyone.</li>
</ul>
<p><strong>Pitfalls</strong></p>
<p>All of the common approaches have issues – some more than others – but they also have merits.</p>
<p>Doing nothing carries the most obvious risk, even if it’s backed by the formal retention schedule, because you risk both keeping and losing emails that you shouldn’t. Without any kind of technical rules or limitations within the email, you’re exposing the organization to a lot of ROT (redundant, outdated, and trivial information) that is subject to e-discovery, theft, and misuse.</p>
<blockquote><p><strong><em>It is common practice for opposing attorneys to hire teams of analysts for the express purpose of combing through email for the “smoking gun”</em></strong></p></blockquote>
<p>Having a safety net helps to address the inadvertent deletion of important emails, but only for the time set by the vault or policy. If there is content within emails that should be kept longer, then the vault does not help – except where individuals make conscious choices to save important items. It also exposes the organization to the risk of discovery, which can include the costs of the discovery effort itself, as well as the potential of finding damaging information. Indeed, it is common practice for opposing attorneys to hire teams of analysts for the express purpose of combing through email for the “smoking gun” that will help them win the case or force a settlement.</p>
<p>Limits on in-boxes in the form of quotas or time limits can help with keeping email from accumulating. It also enforces the idea that an inbox is only meant for short term preservation. However, this approach still lacks several fundamental principles that should govern business records, such as: determining retention based on content, rather than format; distinguishing between records and non-records; and providing a means to preserve long term records.</p>
<p>Purge days are relatively easy to implement and can get everyone on the same path for a shared goal. Although, most users rarely will have the time or patience required to do an effective job at managing email manually. Accordingly, purge days may look good on paper, but rarely succeed in practice.</p>
<p>The Capstone approach has merit in that it does limit the scope of what is collected and managed, which is a good starting point for any email management process. However, it often leads to over-retention of information because retention is based on the person’s role, even if they might retain all kinds of different content, much of which may have no value.</p>
<p>Let it suffice to say that without defined controls on email repositories along with a pathway for users to be compliant, you’re leaving it up to each employee to dictate their own email policies. This can create a lot of problems for the organization – the most notable being that each email is subject to discovery in litigation. Under the right circumstances, what an employee intended to say casually and innocently in an email can cause great damage to an organization in the form of potentially significant liability in litigation.  Email can also contain a wealth of proprietary and valuable intellectual property that could pose a very real threat to the organization if it ever got out. And finally, the confidentiality of email can be compromised, exposing customer, employees, and the organization to breaches in security and privacy.</p>
<p><strong>Recommendations</strong></p>
<p>No individual solution will work for all, and any effective solution will likely use a combination of a policy, technology, and collaboration, and may include elements of the approaches outlined above. For example, it’s often very helpful to limit how much you can keep in an inbox (through quotas or time limits), but also have a vault to act as your safety net.</p>
<p>Good email management starts by creating policies. An organization needs to define what constitutes a record, the various types of records with appropriate retention rules, and how those definitions and rules can be applied to email. A policy will also define an organization’s risk appetite, which will drive how much and how long email is kept. For example, an organization that is concerned with losing important, regulated information will keep more emails, and keep them longer. An organization that is worried more about what could be found (such as PII) will keep less, and keep it shorter.</p>
<p>Temper your policy design with a clear understanding of each department’s needs and their typical use of email. You may need to create some exceptions for certain departments, or for departments that you know are heavy users of email. Certain roles within departments may also be a useful guide, especially for users with very narrowly-defined roles where the majority of emails they process all pertain to a similar subject, like invoices or contracts.</p>
<p>Technology will undoubtedly be a key to your organization’s email management solution. This is because you will need a long-term repository for saving, holding, and disposing of important emails according to your retention policy (either as a separate repository or one applied directly to your email system). Keep in mind, though, that the technology must be easy for the users. Incorporating simple drag-and-drop options, seamless mapping to pre-defined categories, or automatic sorting using artificial intelligence (AI) all serve this goal.</p>
<blockquote><p><strong><em>Ongoing adherence to policy is fostered when employees truly understand why it is important to follow policies</em></strong><strong><em>.</em></strong></p></blockquote>
<p>Many organizations are relying more on AI to help manage email because the volume of information is simply too large to manage without automation. But when exploring this approach, keep in mind that AI systems still require significant time investments up front to properly train the system to identify one type of record from another. Nonetheless, AI can be a significant time saver over the long term.</p>
<p>Another option (and one which expands on the example given in the opening paragraph of this section) is creating a policy which permits users to keep email in their inbox no longer than a few months, but provides an easy way to save long-term emails into an official repository (perhaps with automation). As an additional layer of backup, all email is saved in a vault for 2 years in case something is not saved or categorized properly. Retrieving from the vault would require additional work, thereby discouraging the use of it as a standard fallback.</p>
<p>Collaboration may be the most important factor in an effective email strategy. To succeed, this task requires cohesion between legal, IT, and the entire user population (at minimum). Ease-of-use equals ease-of-adoption by users, and ongoing adherence to policy is fostered when employees truly understand why it is important to follow policies. Investing in training, incentives, audits, and regular communication will reinforce policy and practices, which will translate into better outcomes.</p>
<p><strong>Moving Forward</strong></p>
<p>Organizations that get their email management in order enjoy not only the peace of mind that results from regulatory compliance, but also improved workflow and the ability to find important business records. Look for providers and partners, like Zasio, that have a combination of capability, expertise, and vision to help you get the most value out of your information.</p>
<div><em>Disclaimer: The purpose of this post is to provide general education on Information Governance topics. The statements are informational only and do not constitute legal advice. If you have specific questions regarding the application of the law to your business activities, you should seek the advice of your legal counsel.</em></div>
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		<title>Race for a Vaccine: Recordkeeping Implications for Pharmaceutical Companies</title>
		<link>https://zasio.com/record-keeping-implications-pharmaceutical-companies/</link>
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		<dc:creator><![CDATA[Zasio]]></dc:creator>
		<pubDate>Wed, 09 Sep 2020 19:43:33 +0000</pubDate>
				<category><![CDATA[Blog]]></category>
		<category><![CDATA[By Heather Houle]]></category>
		<category><![CDATA[data management]]></category>
		<category><![CDATA[electronic records]]></category>
		<category><![CDATA[Heather Houle]]></category>
		<category><![CDATA[pharmaceutical industry]]></category>
		<category><![CDATA[recordkeeping]]></category>
		<category><![CDATA[records and information management]]></category>
		<category><![CDATA[trial documentation]]></category>
		<category><![CDATA[vaccine records]]></category>
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					<description><![CDATA[<p>The post <a href="https://zasio.com/record-keeping-implications-pharmaceutical-companies/" data-wpel-link="internal">Race for a Vaccine: Recordkeeping Implications for Pharmaceutical Companies</a> appeared first on <a href="https://zasio.com" data-wpel-link="internal">Zasio</a>.</p>
]]></description>
										<content:encoded><![CDATA[<div class="et_pb_section et_pb_section_3 et_section_regular" >
				
				
				
				
				
				
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				<div class="et_pb_text_inner">The world is in a race to manufacture and produce a safe vaccine for COVID-19. This has led to an unprecedented pace and volume of clinical trial documentation for the many companies and organizations competing in this race and particular implications for trial participant consent and pharmacovigilance requirements.</p>
<p>In the race for a vaccine, Russia recently unveiled “Operation Sputnik,” approving a vaccine ready for human use and is being administered to essential workers. Russia is the first country to claim it has a working vaccine. China revealed it has approved an experimental vaccine and is administering doses to high-risk professionals and military personnel. The United States announced “Operation Warp Speed,” spending billions on pharmaceutical contracts to manufacture and distribute a COVID-19 vaccine. Several pharmaceutical companies around the world are in the final phases of the vaccine clinical trials.</p>
<p>From preclinical testing to the last phase of clinical studies, it takes years for an experimental drug to be manufactured and produced for human use. The COVID-19 vaccine has been fast-tracked to be manufactured and ready for human use within a matter of months, not years. The expedited development brings up concerns about managing the amount of data gathered for these trials and the speed at which the procedures and documentation are occurring. To demonstrate compliance with Good Clinical Practice standards, every essential aspect of a clinical study must be documented.</p>
<p>The United States Food and Drug Administration produced a guideline in March 2020 (updated in July 2020) outlining procedures for clinical trials during the pandemic. The document refers to Part 312 of section 21 of the Code of Federal Regulations which addresses the records that need to be kept for new pharmaceutical drugs, including regulations for clinical investigators. The 2020 guidance document highlights procedures for obtaining and keeping consent documentation<a href="https://www.zasio.com/record-keeping-implications-pharmaceutical-companies/#_ftn1" name="_ftnref1" data-wpel-link="internal">[1]</a>. “When feasible, we recommend a traditional method of obtaining and documenting informed consent using a signed paper copy of the consent form, or use of electronic informed consent”. But what if the written consent by the trial participant is not possible? The USDA guidance document provides two additional methods for consent:</p>
<ul>
<li>“Method 1: A photograph of the signed informed consent document can be transmitted to the trial staff. The patient (or an individual in the room) takes a photograph of the signed informed consent document and sends it to the investigator/designee. A trial team member enters the photograph into the trial records along with an attestation that states how that photograph was obtained and that it is a photograph of the informed consent document signed by the patient.”</li>
<li>“Method 2: A witness can attest to the signature, but a photograph of the signed informed consent document cannot be transmitted. When using a witness, documentation in the trial records includes: (1) a signed and dated attestation by the witness who participated on the call that the patient confirmed their agreement to participate in the trial and signed the informed consent document.</li>
</ul>
<p>The European Medicines Agency also produced guidance documentation regarding Clinical Trials and procedures<a href="https://www.zasio.com/record-keeping-implications-pharmaceutical-companies/#_ftn2" name="_ftnref2" data-wpel-link="internal">[2]</a>. This document also refers to Directive 2001/20 EC Good Clinical Practice for the conduct of clinical trials on medicinal products for human use which addresses record-keeping practices. The guidance document added:</p>
<p>…the following specific aspects should be taken into account with trials involving COVID-19 patients:</p>
<ul>
<li>If written consent by the trial participant is not possible (for example because of physical isolation due to COVID-19 infection), consent could be given orally by the trial participant (Art 2(j) of Directive 2001/20/EC) in the presence of an impartial witness. In such cases, the witness is required to sign and date the informed consent form and the investigator is expected to record how the impartial witness was selected.</li>
<li>In addition, it could be considered that the trial participant and the person obtaining consent sign and date separate informed consent forms. In either case, all relevant records should be archived in the investigator’s site master file. A correctly signed and dated informed consent form should be obtained from the trial participant later, as soon as possible.</li>
</ul>
<p>What about the pharmacovigilance aspect? <a href="https://www.who-umc.org/global-pharmacovigilance/covid-19/how-to-report-icsrs-for-covid-19-treatments/" data-wpel-link="external" rel="external noopener noreferrer">Monitoring the safety of medicines</a> is a top priority for pharmaceutical companies. The UK Medicines and Health Regulatory Authority released guidance as to what documents need to be kept for pharmacovigilance inspections since the manner of inspections have changed because of the pandemic.<a href="https://www.zasio.com/record-keeping-implications-pharmaceutical-companies/#_ftn3" name="_ftnref3" data-wpel-link="internal">[3]</a> These documents include: “procedural documents (such as SOPs, working instructions, and guides); outputs from pharmacovigilance activities such as safety review meeting minutes; documented product safety reviews; audit risk assessments; agreements in place with partners and service providers”. The 2020 Guide by the USDA touches on pharmacovigilance data they require pharmaceutical companies to keep, “data, which includes the pre-licensure clinical safety database, preclinical data, and available safety information for related vaccines, among other considerations”. There will be extra scrutiny for pharmacovigilance documents as these vaccines are being used globally on a wider scale.</p>
<p>Good Clinical Practice has always set forth very particular and detailed standards for recordkeeping during clinical studies and trials. It is now more important than ever to adapt to regulatory changes. Pharmaceutical companies are receiving, reporting, and creating records on the effectiveness of the vaccine at an accelerated rate. <a href="https://www.zasio.com/about-us/contact-us/" data-wpel-link="internal">Contact Zasio today</a> to determine whether your company is up to date with the influx of clinical record keeping requirements, pharmacovigilance record keeping, and GDPR requirements.</p>
<p>&nbsp;</p>
<p><a href="https://www.zasio.com/record-keeping-implications-pharmaceutical-companies/#_ftnref1" name="_ftn1" data-wpel-link="internal">[1]</a> <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency" data-wpel-link="external" rel="external noopener noreferrer">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency</a></p>
<p><a href="https://www.zasio.com/record-keeping-implications-pharmaceutical-companies/#_ftnref2" name="_ftn2" data-wpel-link="internal">[2]</a> <a href="https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf" data-wpel-link="external" rel="external noopener noreferrer">https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf</a></p>
<p><a href="https://www.zasio.com/record-keeping-implications-pharmaceutical-companies/#_ftnref3" name="_ftn3" data-wpel-link="internal">[3]</a> <a href="https://www.gov.uk/guidance/good-pharmacovigilance-practice-gpvp" data-wpel-link="external" rel="external noopener noreferrer">https://www.gov.uk/guidance/good-pharmacovigilance-practice-gpvp</a></p>
<p>&nbsp;</p>
<div><em>Disclaimer: The purpose of this post is to provide general education on Information Governance topics. The statements are informational only and do not constitute legal advice. If you have specific questions regarding the application of the law to your business activities, you should seek the advice of your legal counsel.</em></div></div>
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				<div class="et_pb_team_member_image et-waypoint et_pb_animation_off"><img loading="lazy" decoding="async" width="96" height="96" src="https://zasio.com/wp-content/uploads/2022/01/Heather-Houle-01-96x96-1.jpg" alt="Author: Heather Houle, CRA" class="wp-image-2067" /></div>
				<div class="et_pb_team_member_description">
					<h4 class="et_pb_module_header">Author: Heather Houle, CRA</h4>
					<p class="et_pb_member_position">Senior Research Analyst / Certified Paralegal</p>
					
					
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		<title>Archive Law, Is It Just Applicable to Governments?</title>
		<link>https://zasio.com/archive-law-is-it-just-applicable-to-governments/</link>
					<comments>https://zasio.com/archive-law-is-it-just-applicable-to-governments/#respond</comments>
		
		<dc:creator><![CDATA[Zasio]]></dc:creator>
		<pubDate>Wed, 26 Jun 2019 21:03:30 +0000</pubDate>
				<category><![CDATA[Blog]]></category>
		<category><![CDATA[By Heather Houle]]></category>
		<category><![CDATA[archive law]]></category>
		<category><![CDATA[Heather Houle]]></category>
		<category><![CDATA[National Archive Agency]]></category>
		<category><![CDATA[record retention requirements]]></category>
		<category><![CDATA[recordkeeping]]></category>
		<category><![CDATA[records retention]]></category>
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					<description><![CDATA[<p>The post <a href="https://zasio.com/archive-law-is-it-just-applicable-to-governments/" data-wpel-link="internal">Archive Law, Is It Just Applicable to Governments?</a> appeared first on <a href="https://zasio.com" data-wpel-link="internal">Zasio</a>.</p>
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				<div class="et_pb_text_inner">A National Archives Agency preserves official documents, photos, artifacts and records that have important historical value to a country. The purpose of an Archive’s Agency is to preserve these important records for future generations and provide public access to these records.</p>
<p>Why are archive laws so important? Archive laws set out standards for preservation of records and regulations for accurate record-keeping from their creation to disposal or storage.  Archive laws also set mandatory standards for security, storage conditions, protection of records from damage or loss, as well as conditions for storing records in specific mediums.</p>
<p>At first glance, archive law requirements could be understood as being only applicable to governments and their preservation of valuable historical, scientific, social, economic and cultural records.  While most archive laws are focused on government agencies, in some countries, such as the Eastern Block of Europe and China, archive laws can extend record-keeping requirements to include public corporations and non-governmental organizations. Do not be quick to ignore archive laws based on the assumption that they apply only to governments and the retention of historical records. Organizations that are guilty of violating archive law requirements in these countries could potentially bear civil, administrative and criminal liability.</p>
<p>A few areas where an organization could potentially be impacted are as follows:</p>
<ul>
<li>Administrative and internal regulations of an organization</li>
<li>Accounting and payroll</li>
<li>Tax</li>
<li>Labor</li>
<li>Occupational accidents and hazards</li>
<li>Social security/pensions</li>
<li>Environmental</li>
</ul>
<p>Below are examples that include archive law requirements applicable to some types of corporations and non-governmental organizations:</p>
<ul>
<li>Russia’s Order of August 25, 2010, N 558 on archival documents encompasses “state bodies, local governments and organizations”, while Russia’s Archival Documents of Scientific, Technical and Production Activities Order is applicable to “archival documents on scientific, scientific-technical, production-technical, design and construction activities of organizations, with an indication of the shelf life applied in various sectors of the economy”.</li>
<li>China’s National Archives Order 10 applies to “enterprises registered and established within the territory of the People’s Republic of China”.</li>
<li>Poland’s Dz. U. 1983 No. 38 item 173 Archive Act applies to “entrepreneurs” and “business activity in the field of personal documentation, storage and payroll of employers with a temporary storage period”.</li>
<li>Latvia’s Archival Law applies to “every institution, as well as to individuals, who have documents with archival value…and natural or legal person exercising an economic activity engaged in an economic activity, or on the basis of a contract of employment, business or author, and other persons as well as an association of person”.</li>
</ul>
<p>When deciding if an archives law applies to your specific industry, it is helpful to look for an explanation of the law on the country’s main archive website or secondary sources. This can help determine the applicability to your specific industry.</p>
<p>It is important to note that countries are updating their archive laws to reflect changing privacy and data protection legislation. Changes to archive laws aim to correct gaps in definitions, transferring of records within a country and cross-border transferring requirements, location requirements, conditions and disposal of records. For example, Poland’s Data Protection Law repealed a fifty-year retention requirement applicable to employers from its Archive Act. Although the retention was repealed from the Archive Act, it can still be found in other employment laws. Because governments are continuously evaluating and strengthening privacy and data protection, there is potential for further repeal of archival record requirements.</p>
<p>If you need help interpreting how archival laws impact your business, <a href="https://www.zasio.com/about-us/contact-us/" data-wpel-link="internal">contact Zasio</a> and speak with our team of in-house experts.</p>
<p><em>Disclaimer: The purpose of this post is to provide general education on Information Governance topics. The statements are informational only and do not constitute legal advice. If you have specific questions regarding the application of the law to your business activities, you should seek the advice of your legal counsel.</em></div>
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					<h4 class="et_pb_module_header">Author: Heather Houle, CRA</h4>
					<p class="et_pb_member_position">Senior Research Analyst / Certified Paralegal</p>
					
					
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		<title>Zasio Gifts Scholarship to San José State University School of Information</title>
		<link>https://zasio.com/zasio-gifts-scholarship-to-san-jose-state-university/</link>
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		<dc:creator><![CDATA[Zasio]]></dc:creator>
		<pubDate>Tue, 03 Oct 2017 19:37:16 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<category><![CDATA[information governance]]></category>
		<category><![CDATA[information management]]></category>
		<category><![CDATA[iSchool]]></category>
		<category><![CDATA[recordkeeping]]></category>
		<category><![CDATA[records management]]></category>
		<category><![CDATA[San Jose State]]></category>
		<category><![CDATA[SJSU]]></category>
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					<description><![CDATA[<p>BOISE, ID — To celebrate 30 years in business, Zasio Enterprises, Inc. gifted a scholarship to the San José State University Masters in Archives and Records Administration Program. CEO Kevin Zasio presented the program with a scholarship to support the efforts of graduate students hoping to advance their education in the field. Zasio, a records management and information governance software and consulting company, was founded in San José in 1987. Since the company achieved three decades in the industry, Kevin returned to his roots to gift the scholarship to the community that first supported it. “Because almost every business creates, uses, stores, and disposes of data, and must adhere to evolving laws and regulations, there’s never been a greater need for talented, driven students,” Kevin said. “As more records are stored digitally, information governance expertise is vital for businesses success. It’s an honor to give back to the students at SJSU, who have the potential to give those businesses confidence in records management.” Kevin and his team are passionate about information governance and the fields it encompasses. They believe the world needs more bright minds and innovative thinkers in the industry. Companies that put their confidence in information governance mitigate [&#8230;]</p>
<p>The post <a href="https://zasio.com/zasio-gifts-scholarship-to-san-jose-state-university/" data-wpel-link="internal">Zasio Gifts Scholarship to San José State University School of Information</a> appeared first on <a href="https://zasio.com" data-wpel-link="internal">Zasio</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>BOISE, ID — To celebrate 30 years in business, Zasio Enterprises, Inc. gifted a scholarship to the San José State University Masters in Archives and Records Administration Program. CEO Kevin Zasio presented the program with a scholarship to support the efforts of graduate students hoping to advance their education in the field.</p>
<p>Zasio, a records management and information governance software and consulting company, was founded in San José in 1987. Since the company achieved three decades in the industry, Kevin returned to his roots to gift the scholarship to the community that first supported it.</p>
<p>“Because almost every business creates, uses, stores, and disposes of data, and must adhere to evolving laws and regulations, there’s never been a greater need for talented, driven students,” Kevin said. “As more records are stored digitally, information governance expertise is vital for businesses success. It’s an honor to give back to the students at SJSU, who have the potential to give those businesses confidence in records management.”</p>
<p>Kevin and his team are passionate about information governance and the fields it encompasses. They believe the world needs more bright minds and innovative thinkers in the industry. Companies that put their confidence in information governance mitigate the risks of non-compliance with recordkeeping laws.</p>
<p>There are many ﬂuid qualities in business that impact information governance decisions from cost, beneﬁt, and risk perspectives. And because information governance trends are always changing, the company hopes to encourage interest in the field and nurture continued education.</p>
<p>“I know the iSchool recipient will be very grateful, and this award will help the student achieve their career aspirations in the records and information management field,” said Sandy Hirsh, Director for the SJSU School of Information.</p>
<p>There are currently 24 iSchool scholarships available to students at SJSU, providing more than $27,000 in financial assistance every year. iSchool scholarships are donated by faculty, students, and alumni, and they’re awarded based on academic merit.</p>
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		<title>Electronic Recordkeeping and the Managing Government Records Directive</title>
		<link>https://zasio.com/electronic-recordkeeping-and-the-managing-government-records-directive/</link>
					<comments>https://zasio.com/electronic-recordkeeping-and-the-managing-government-records-directive/#respond</comments>
		
		<dc:creator><![CDATA[Zasio]]></dc:creator>
		<pubDate>Thu, 20 Apr 2017 18:44:25 +0000</pubDate>
				<category><![CDATA[Blog]]></category>
		<category><![CDATA[By Jared Walker]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[directive]]></category>
		<category><![CDATA[electronic records]]></category>
		<category><![CDATA[email]]></category>
		<category><![CDATA[executive agencies]]></category>
		<category><![CDATA[Jared Walker]]></category>
		<category><![CDATA[managing government records]]></category>
		<category><![CDATA[NARA]]></category>
		<category><![CDATA[OMB]]></category>
		<category><![CDATA[paper records]]></category>
		<category><![CDATA[recordkeeping]]></category>
		<category><![CDATA[records management]]></category>
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					<description><![CDATA[<p>The post <a href="https://zasio.com/electronic-recordkeeping-and-the-managing-government-records-directive/" data-wpel-link="internal">Electronic Recordkeeping and the Managing Government Records Directive</a> appeared first on <a href="https://zasio.com" data-wpel-link="internal">Zasio</a>.</p>
]]></description>
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				<div class="et_pb_text_inner"><div class="post-thumbnail"><img loading="lazy" decoding="async" class="preload-me lazy-load aspect is-loaded" title="2017 Zasio Article Electronic Recordkeeping and the Managing Government Records Directive" src="https://cdn.zasio.com/wp-content/uploads/2017/04/2017-Zasio-Article-Electronic-Recordkeeping-and-the-Managing-Government-Records-Directive-800x400.jpg" sizes="(max-width: 800px) 100vw, 800px" srcset="https://cdn.zasio.com/wp-content/uploads/2017/04/2017-Zasio-Article-Electronic-Recordkeeping-and-the-Managing-Government-Records-Directive-800x400.jpg 800w" alt="2017 Zasio Article Electronic Recordkeeping and the Managing Government Records Directive" width="800" height="400" /></div>
<div class="entry-content">
<p>On November 28, 2011, President Obama signed a Presidential Memorandum entitled <a href="https://obamawhitehouse.archives.gov/the-press-office/2011/11/28/presidential-memorandum-managing-government-records" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">Managing Government Records</a>, initiating “an Executive Branch-wide effort to reform records management policies and practices” of agencies by developing a “21st-century framework for the management of Government records.” To achieve this objective, the Director of the Office of Management and Budget (OMB) and the United States Archivist released the <a href="https://www.archives.gov/files/records-mgmt/m-12-18.pdf" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">Managing Government Records Directive</a> on August 24, 2012. Applicable to all executive agencies and all records, regardless of security classification or other restrictions, the directive requires government agencies to eliminate paper and use electronic recordkeeping, among other things.</p>
<p>The directive sets two target dates by which agencies must meet the electronic recordkeeping requirements:</p>
<ul>
<li>By <strong>December 31, 2016</strong>, Federal agencies will manage permanent and temporary email records in an electronic format. This format must support records management and litigation requirements, as well as the capability to “identify, retrieve, and retain the records for as long as they are needed.” In addition, agencies must report annually to OMB and the National Archives and Records Administration (NARA) the status of their progress toward the electronic recordkeeping goal.</li>
<li>By <strong>December 31, 2019</strong>, Federal agencies will manage all permanent electronic records in an electronic format.</li>
</ul>
<p>&nbsp;</p>
<p>While agencies are expected to comply with these deadlines, <a href="https://fcw.com/articles/2017/03/22/more-missing-email-deadline.aspx" data-wpel-link="external" rel="external noopener noreferrer">only an estimated 81%</a> have hit the 2016 email electronic format compliance goal so far. In light of this, Laurence Brewer, the Federal chief records officer at NARA, <a href="https://fcw.com/Articles/2016/12/22/email-deadline-mazmanian.aspx?Page=1" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">explained in a 2016 FCW interview</a> that “[t]here really isn’t a finish line…[i]t’s one of those targets where agencies will continue to work on it, and we’re going to continue to work with agencies.” He <a href="https://fcw.com/articles/2017/03/22/more-missing-email-deadline.aspx" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">further explained</a> that NARA sought to collaborate and work with agencies in their records management issues and efforts rather than punish them for missing a deadline.</p>
<p>According to agency self-reporting data, a <a href="https://fcw.com/articles/2017/03/22/more-missing-email-deadline.aspx" target="_blank" rel="noopener external noreferrer" data-wpel-link="external">projected 95% of agencies</a> will meet the 2019 electronic records management deadline. For this to happen, agencies should start planning and implementing strategies now to successfully convert to a comprehensive electronic recordkeeping system. 2019 is fast approaching.</p>
<p><a href="https://www.zasio.com/about-us/contact-us/" data-wpel-link="internal">Contact Zasio</a> today to see how our host of software solutions and consulting services can help you stay complaint with your data retention policies and practices.</p>
<p>&nbsp;</p>
<p><em>Disclaimer: The purpose of this post is to provide general education on Information Governance topics. The statements are informational only and do not constitute legal advice. If you have specific questions regarding the application of the law to your business activities, you should seek the advice of your legal counsel.</em></p>
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					<h4 class="et_pb_module_header">Author: Jared Walker, JD</h4>
					<p class="et_pb_member_position">Senior Research Analyst, Team Lead / Licensed Attorney</p>
					
					
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