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	<title>Comments on: Pedigree Models and Supply Chain Master Data</title>
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	<link>http://www.rxtrace.com/2009/10/pedigree-models-and-supply-chain-master-data.html/</link>
	<description>A comprehensive exploration of the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance</description>
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		<title>By: Dirk Rodgers</title>
		<link>http://www.rxtrace.com/2009/10/pedigree-models-and-supply-chain-master-data.html/comment-page-1/#comment-17</link>
		<dc:creator>Dirk Rodgers</dc:creator>
		<pubDate>Wed, 21 Oct 2009 00:03:11 +0000</pubDate>
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		<description>Both of my anonymous commenters are jumping ahead of me.  I am planning an essay on what I think state legislatures and Congress are trying to accomplish when they pass pedigree or track and trace legislation.  Only by knowing that will we be able to tell whether SCMD ought to be allowed by regulators or not.  &lt;br /&gt;&lt;br /&gt;As my second commenter rightly points out, unless the regulator explicitly gives you permission in writing to deviate from the text of a law or regulation, you had better follow it as it is written.  If the end side-effects of the use of SCMD are in conflict with the reason these laws were created in the first place, no amount of explaining modern software patterns will cause the regulator to bend the rules to allow it.&lt;br /&gt;&lt;br /&gt;On the other hand, if there is no conflict, then maybe they will...but don&#039;t count on it even then.&lt;br /&gt;&lt;br /&gt;Dirk.</description>
		<content:encoded><![CDATA[<p>Both of my anonymous commenters are jumping ahead of me.  I am planning an essay on what I think state legislatures and Congress are trying to accomplish when they pass pedigree or track and trace legislation.  Only by knowing that will we be able to tell whether SCMD ought to be allowed by regulators or not.  </p>
<p>As my second commenter rightly points out, unless the regulator explicitly gives you permission in writing to deviate from the text of a law or regulation, you had better follow it as it is written.  If the end side-effects of the use of SCMD are in conflict with the reason these laws were created in the first place, no amount of explaining modern software patterns will cause the regulator to bend the rules to allow it.</p>
<p>On the other hand, if there is no conflict, then maybe they will&#8230;but don&#39;t count on it even then.</p>
<p>Dirk.</p>
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		<title>By: Anonymous</title>
		<link>http://www.rxtrace.com/2009/10/pedigree-models-and-supply-chain-master-data.html/comment-page-1/#comment-16</link>
		<dc:creator>Anonymous</dc:creator>
		<pubDate>Tue, 20 Oct 2009 17:04:11 +0000</pubDate>
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		<description>I believe the answer is simpler than that.  Unlike other systems&#039; designs, where you may get to haggle over the requirements, laws are often pretty strict.  If it states that an address is required, than you provide an address, not a pointer to an address.&lt;br /&gt;&lt;br /&gt;Being able to use a GLN could require a change in the law or the regulation.  We technologists don&#039;t get to make this call (even for a reasonable reason like reduced data volumes) if we want to call ourselves compliant with the law(s).</description>
		<content:encoded><![CDATA[<p>I believe the answer is simpler than that.  Unlike other systems&#39; designs, where you may get to haggle over the requirements, laws are often pretty strict.  If it states that an address is required, than you provide an address, not a pointer to an address.</p>
<p>Being able to use a GLN could require a change in the law or the regulation.  We technologists don&#39;t get to make this call (even for a reasonable reason like reduced data volumes) if we want to call ourselves compliant with the law(s).</p>
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	<item>
		<title>By: Anonymous</title>
		<link>http://www.rxtrace.com/2009/10/pedigree-models-and-supply-chain-master-data.html/comment-page-1/#comment-15</link>
		<dc:creator>Anonymous</dc:creator>
		<pubDate>Tue, 20 Oct 2009 13:31:30 +0000</pubDate>
		<guid isPermaLink="false">http://rxtrace.com/?p=16#comment-15</guid>
		<description>In your post you indicate:&lt;br /&gt;&lt;br /&gt;“Use of SCMD doesn’t comply with any pedigree laws because they all specify exactly what must be contained in a pedigree, and this always includes the full address of those who owned and/or had possession of each unit.”&lt;br /&gt;&lt;br /&gt;There are some whoe would say SCMD could enable compliance with pedigree laws.  Continuing your use of the GLN example, the GLN number can be used to retrieve the full address and include that in the pedigree to the regulators when needed.&lt;br /&gt;&lt;br /&gt;The benefits of this approach are smaller amounts of data need to be passed between trading partners.&lt;br /&gt;&lt;br /&gt;However, there are &quot;persistency&quot; risks with the approach:&lt;br /&gt;- downstream recipients don’t have the full MD.  Whoever maintains the MD could change it after the fact.&lt;br /&gt;- at the point the downstream trading partner tries to retrieve the full MD the information may not be available (system down, company no longer in business, etc).  &lt;br /&gt;&lt;br /&gt;So a key question is whether the reduction in data volumes is worth the &quot;persistency&quot; risks?</description>
		<content:encoded><![CDATA[<p>In your post you indicate:</p>
<p>“Use of SCMD doesn’t comply with any pedigree laws because they all specify exactly what must be contained in a pedigree, and this always includes the full address of those who owned and/or had possession of each unit.”</p>
<p>There are some whoe would say SCMD could enable compliance with pedigree laws.  Continuing your use of the GLN example, the GLN number can be used to retrieve the full address and include that in the pedigree to the regulators when needed.</p>
<p>The benefits of this approach are smaller amounts of data need to be passed between trading partners.</p>
<p>However, there are &quot;persistency&quot; risks with the approach:<br />- downstream recipients don’t have the full MD.  Whoever maintains the MD could change it after the fact.<br />- at the point the downstream trading partner tries to retrieve the full MD the information may not be available (system down, company no longer in business, etc).  </p>
<p>So a key question is whether the reduction in data volumes is worth the &quot;persistency&quot; risks?</p>
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