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	<title>The Integrated Lab &#187; Records Retention</title>
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		<title>eOrganizedWorld Online Information Management Newsletter</title>
		<link>http://theintegratedlab.com/2010/08/eorganizedworld-online-information-management-newsletter-7/</link>
		<comments>http://theintegratedlab.com/2010/08/eorganizedworld-online-information-management-newsletter-7/#comments</comments>
		<pubDate>Fri, 13 Aug 2010 15:33:11 +0000</pubDate>
		<dc:creator>Charlie Sodano</dc:creator>
				<category><![CDATA[Compliance]]></category>
		<category><![CDATA[Document Management]]></category>
		<category><![CDATA[IP Protection]]></category>
		<category><![CDATA[Industry]]></category>
		<category><![CDATA[Legal]]></category>
		<category><![CDATA[Newsletters]]></category>
		<category><![CDATA[Records Retention]]></category>

		<guid isPermaLink="false">http://theintegratedlab.com/?p=841</guid>
		<description><![CDATA[<p>Media for Learning
It wasn’t that long ago when the only books to read were printed on paper.  Electronic books have been around for more than 15 years, but only recently have caught on with the public.  Try to remember the last time that you read a one of two pages that was hand written. [...]]]></description>
			<content:encoded><![CDATA[<p><strong>Media for Learning</strong><br />
It wasn’t that long ago when the only books to read were printed on paper.  Electronic books have been around for more than 15 years, but only recently have caught on with the public.  Try to remember the last time that you read a one of two pages that was hand written.  Do you really want to? Are you able to handwrite 2 pages anymore? </p>
<p>I scribble notes on a pad when I conduct interviews for my business.  I don’t write many words because I’m trying to understand what people are saying and can’t write and think at the same time. (Half-Polish, can’t chew gum either).  My notes are becoming more difficult to reread after a period of time too because my handwriting skills have diminished.  Except for my grocery shopping list, I rarely use paper Post Its anymore, preferring electronic versions that are available on most newer PCs and phones.  Like most people with Smart phones, I take out mine out frequently so see the reminders often. So this approach works well for me.  I do have a paper scribble pad (recycled paper!) that I use every day with a pencil to capture transient bits of information that I use during the day.  I throw out the scribbles next day and start a new sheet.  This is still more efficient and convenient than a computer based approach.</p>
<p>The way that we read information to acquire knowledge has been gradually transforming.  Before electronics, brief communication of information (today’s tweets, text messages or emails) was commonly done via oral interaction or sign images like smoke signals, semaphores, etc.  The telegraph and telephone replaced these and has broadened the potential audience.  Global electronic networks are the phase that we are in now.  These kinds of communications usually only convey relatively small bits of information or knowledge. Think about trying to get a university degree by only reading tweets and text messages.  That’s not going to get it done.</p>
<p>The applicability of collaborative space has been spotty.  There are some specific successes, but in general this idea has not expanded significantly over the past 20 years.  Remember Lotus Notes?</p>
<p>Conveying more complex concepts and ideas, requires a much more structured use of many words than these communication vehicles can easily provide.  Most people scan through pages bought up by web search results looking for key words of phrases.  They rarely read a page word by word.</p>
<p>So what’s the best medium to read a book or long document?  I can tolerate reading no more than 3 pages max word for word on my PC screen.  Some days, like today, it’s less than one page. It’s the screen angle and overall brightness that gets to me.   You can carry around and tilt paper pages, books and eReaders to accommodate your sitting or standing position.  Also, most eReaders have the capability of increasing font size which I often do when my eyes get tired at the end of a day. They also are not overly bright, but have good black/white contrast.  Most models can’t be read in the dark.  I often print a few pages of information to read and then reuse the paper for scribbling.  I don’t keep the printed sheets for very long.</p>
<p>I print fewer items to read than I did last year and think that this is because I am scanning, skimming speed reading more.  Everyone seems to be doing this and I’m not sure whether it is good or bad. Are we learning less and just recycling information more?</p>
<p>When paper was king, I read many articles and books word for word then composed my original work.  I’m sure I plagiarized some things without giving credit to the proper author, but I (as do many university professors) are seeing many articles, blogs and white papers that are primarily information that has been cut and pasted from other sources and advertised as “original” work.</p>
<p>I think that we have to be more selective in the use of our time to acquire new knowledge.  Texting, tweeting, information skimming, social networking and other activities can take away too many hours every day and inhibit our capability to compose original ideas.</p>
<hr/>
What’s new?</p>
<hr/>
<strong>Records &#038; Archiving</strong><br />
Iron Mountain Incorporated is combining its services for document scanning, file archiving, data backup and more into one solution for hospitals and healthcare organizations converting hardcopy patient files into an electronic medical record (EMR) system. The new Iron Mountain EMR Enablement Solution offers healthcare organizations a complete set of tools for digitizing patient records, archiving electronic files, protecting them from disaster, and then destroying outdated records.</p>
<p><strong>Electronic Lab Notebooks / Lab Information Management Systems</strong><br />
Labtronics Inc. has released a Connector for Nexxis ELN that allows the Electronic Laboratory Notebook to connect to any LIMS.<br />
Nexxis ELN makes use of the industry standard integration tool, LimsLink, to provide direct connection with any LIMS. The connection provides bi-directional connectivity allowing the Electronic Notebook to retrieve sample lists from LIMS and report results back to LIMS</p>
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		<item>
		<title>eOrganizedWorld Online Information Management Newsletter</title>
		<link>http://theintegratedlab.com/2010/07/eorganizedworld-online-information-management-newsletter-6/</link>
		<comments>http://theintegratedlab.com/2010/07/eorganizedworld-online-information-management-newsletter-6/#comments</comments>
		<pubDate>Fri, 16 Jul 2010 13:46:01 +0000</pubDate>
		<dc:creator>Charlie Sodano</dc:creator>
				<category><![CDATA[IP Protection]]></category>
		<category><![CDATA[Industry]]></category>
		<category><![CDATA[Newsletters]]></category>
		<category><![CDATA[Records Retention]]></category>

		<guid isPermaLink="false">http://theintegratedlab.com/?p=826</guid>
		<description><![CDATA[<p>Why are People Afraid of Change?
My entry into Records and Information Management came about when I got an assignment about 20 years ago to bring new technology into my company.  I soon discovered that scientific breakthroughs were good, but the potential to run your business better and faster, with less manpower, via business process management [...]]]></description>
			<content:encoded><![CDATA[<p><strong>Why are People Afraid of Change?</strong><br />
My entry into Records and Information Management came about when I got an assignment about 20 years ago to bring new technology into my company.  I soon discovered that scientific breakthroughs were good, but the potential to run your business better and faster, with less manpower, via business process management was much more appealing.</p>
<p>A lot of the early projects I implemented concerned the conversion of paper based business operations to computer based.  Through these experiences I learned that the biggest obstacle to implementing new processes was peoples’ inherent fear of change.  This is a basic characteristic of people that has been developed through evolution.  Men are driven by nature to find the highest place for them within a hierarchy and are motivated to protect their position and move up when possible.  Women have different motivations which are concerned with social influence.  But they too will fight to maintain their position and status.</p>
<p>Fear is an emotional response to a perceived threat. It is a basic survival mechanism occurring in response to a specific stimulus, such as pain or the threat of danger.<br />
I have seen all of the following common reactions to fear in some people when I was trying to introduce change:</p>
<ul>
<li>Anger</li>
<li>Increased blood pressure</li>
<li>Tightening of muscles</li>
<li>Dilation of the pupils (to let in more light)</li>
<li>Increased sweating</li>
</ul>
<p>If you see that a lot of people are reacting with fear to the changes you are proposing, things have gone very wrong and most likely the program that you are trying to implement is in serious danger of failing.  Fear is contagious and will spread rapidly.</p>
<p>Here are a few hints on how to minimize the fear reaction.</p>
<p>A person trying to introduce change must first of all be likeable and unthreatening.  This is much more important initially than extensive explanations about why the change will be a good thing for all. You can be likeable when you sincerely try to learn about people whose job scope will be affected.  Be a friend; don’t push your agenda too hard at the beginning.</p>
<p>For many people change will mean making some information that they currently control more public.  They will cease to be the exclusive “go to” person.  This is the “I know something important that no one else knows” power position.  Their new role will be to manage the life cycle of the information collection assuring that it is complete and up to date.  If they are the information authors the new process should advertise that they are the “inventors” and will fortify their position.<br />
Explain this to them.  It may take a little while to sink in, but most of them will get it.</p>
<p>There will always be a few people whose fear level will be too high to overcome initially.  However, after they see that others are not afraid they will come around.</p>
<hr /><strong>What’s new?</strong></p>
<hr /><strong> RECORDS &amp; ARCHIVING</strong><br />
After only a month that Autonomy announced it was buying CA’s information governance business it has already integrated its IDOL search platform into what was CA’s Message Manager<br />
ZL Technologies Inc, announced new enterprise-class social media archiving capabilities. Using FaceTime’s Unified Security Gateway, ZL´s Customers can manage a variety of electronic content, from emails to instant messenger, Sharepoint and social media, using the single repository, policy engine and search interface of ZL Unified Archive.</p>
<p>Iron Mountain Incorporated has expanded its partnership with InterVision to allow the Santa Clara, Calif. IT firm to offer users of NetApp and Microsoft Exchange Iron Mountain&#8217;s newly-acquired NearPoint(TM) solution for archiving, accessing and protecting email. InterVision&#8217;s customers can now enjoy high performance, manageability and lower operating costs by combining leading technology from NetApp and Iron Mountain in a single integrated solution for managing Microsoft Exchange.</p>
<p><strong>ELN / LIMS</strong><br />
In order to minimize disruption to their existing processes and procedures, Novozymes chose to develop their own, custom-built ELN solution. By taking their lab processes digital, Novozymes saves the time it takes for teams of scientists to assemble and authorize paper-based documentation. Through the ELN, documents proving scientific discovery and product inventions (which are later used in patent applications) are approved and trusted via standard digital signatures, and made electronically available to an unlimited number of researchers from remote locations, for years into the future. The potential benefits of enhanced collaboration and document control influenced Novozymes’ decision to base their ELN solution on a SharePoint foundation, a document management platform which they were already using for various other business processes. The addition of digital signatures to the ELN makes the entire solution electronic through-out.</p>
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		<title>The Perpetual Data Machine</title>
		<link>http://theintegratedlab.com/2010/07/the-perpetual-data-machine/</link>
		<comments>http://theintegratedlab.com/2010/07/the-perpetual-data-machine/#comments</comments>
		<pubDate>Mon, 05 Jul 2010 10:06:49 +0000</pubDate>
		<dc:creator>John Trigg</dc:creator>
				<category><![CDATA[Industry]]></category>
		<category><![CDATA[Informatics]]></category>
		<category><![CDATA[Records Retention]]></category>
		<category><![CDATA[data]]></category>
		<category><![CDATA[Data Format]]></category>
		<category><![CDATA[integration]]></category>
		<category><![CDATA[Standards]]></category>

		<guid isPermaLink="false">http://theintegratedlab.com/?p=813</guid>
		<description><![CDATA[<p>Whichever way you look at laboratory integration, sooner or later the &#8216;data&#8217; problem will rear its ugly head.  For years LIMS projects have wrestled with the vagaries of proprietary interfaces and data formats, and it is increasingly becoming an issue within ELN projects.  If you are a LinkedIn member, take a look at this [...]]]></description>
			<content:encoded><![CDATA[<p>Whichever way you look at laboratory integration, sooner or later the &#8216;data&#8217; problem will rear its ugly head.  For years LIMS projects have wrestled with the vagaries of proprietary interfaces and data formats, and it is increasingly becoming an issue within ELN projects.  If you are a LinkedIn member, take a look at this discussion on <a href="http://www.linkedin.com/groupAnswers?trk=view_disc&amp;gid=2723825&amp;commentID=18913031&amp;viewQuestionAndAnswers=&amp;discussionID=23456296" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.linkedin.com/groupAnswers?trk=view_disc_amp_gid=2723825_amp_commentID=18913031_amp_viewQuestionAndAnswers=_amp_discussionID=23456296&amp;referer=');">handling large files in an ELN</a>.</p>
<p>We generate more and more data in the pursuit of further scientific knowledge, and paradoxically, the more we know, the less certain we become, and so we need more data to seek the truth; the perpetual data machine.  Data volumes grow to overwhelming levels; we need to store it somewhere for future reference, and for re-interpretation.  We may also need it for regulatory or legal purposes which means we may need to keep it a long time.  We may need to transfer it to other programmes for processing.  We may need to reduce it to graphical images in order to understand it.  We may need to derive a set of conclusions for inclusion in reports or presentations.  We may need to import data from external agencies, such as CROs.  And we know that data volumes will still continue to grow.</p>
<p>And yet, we don&#8217;t have any accepted intentional standards for the interchange of laboratory data; we don&#8217;t have any agreed integration standards or strategies for data communication; we cannot be confident that today&#8217;s applications, operating systems and media will survive for as long as we need the data to survive.  All in all, it is not a healthy situation or one that inspires confidence, so what hope is there that it could ever get better?  There are perhaps three alternative means by which the situation could change.  Firstly, by force; if a regulatory or legal agency were to demand that all data comply with international standards, then the industry would need to respond, but this seems highly unlikely, certainly in the short term.  Secondly, by community action;  there have been several worthy attempts to evolve international standards either through the adoption of commercially based de facto standards, or by &#8216;standards&#8217; associations formulating standards.  In some instances, this has worked out well.  For example, the adoption of PDF and PDF/A as ISO standards has shown that a global demand for document standards can be achieved by adopting a de facto standard.  However, most initiatives with laboratory data have failed to acquire adequate uptake, and therefore have struggled to have any substantial impact.  The third option is to sit back and wait for technology to provide us with a solution.  To some extent this is already happening with the increasing use of XML for data interchange, but without suitable ontologies, there are still limitations.</p>
<p>Two specific community initiatives are currently addressing the laboratory data problem.  The <a href="http://www.pistoiaalliance.org/" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.pistoiaalliance.org/?referer=');">Pistoia Alliance</a>, an initiative to provide an open foundation of data standards, ontologies and web-services to streamline the Pharmaceutical Drug Discovery workflow (Chemistry, Biological Screening, Logistics) through common business terms, relationships and processes.  The work is currently being undertaken by member companies to develop open standards to support the interchange of data between CROs and their major customers in the Pharmaceutical industry.  With a growing number of members, including vendors, the initiative faces a number of challenges, but probably represents the broadest approach to date to tackle the problem.</p>
<p>The other initiative is <a href="http://animl.sourceforge.net/" target="_blank" onclick="pageTracker._trackPageview('/outgoing/animl.sourceforge.net/?referer=');">AnIML</a>, the goal of which is to serve as the open-source development platform for a new XML standard for Analytical Chemistry Information. The project is a collaborative effort between many groups and individuals and is sanctioned by the ASTM under subcommittee E13.15.  AnIML is receiving attention from vendors, a critical step towards adoption, but lacks the focused business case that is driving the Pistoia Alliance.   Of course, if the Pistoia Aliiance were to adopt AnIML for analytical data interchange……….</p>
<p>The other consideration is how much of the Pistoia Alliance&#8217;s objectives have been addressed within the clinical world where a number of data interchange standards already exist.  There are sufficient parallels with clinical chemistry at the laboratory level to believe that there may be no need to reinvent the wheel, but to adapt existing open standards to the requirements of non-clinical laboratories.  The progress of Pistoia and AnIML will be observed closely</p>
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		<item>
		<title>eOrganizedWorld Online Information Management Newsletter</title>
		<link>http://theintegratedlab.com/2010/06/eorganizedworld-online-information-management-newsletter-5/</link>
		<comments>http://theintegratedlab.com/2010/06/eorganizedworld-online-information-management-newsletter-5/#comments</comments>
		<pubDate>Fri, 18 Jun 2010 13:33:25 +0000</pubDate>
		<dc:creator>Charlie Sodano</dc:creator>
				<category><![CDATA[IP Protection]]></category>
		<category><![CDATA[Industry]]></category>
		<category><![CDATA[Newsletters]]></category>
		<category><![CDATA[Records Retention]]></category>

		<guid isPermaLink="false">http://theintegratedlab.com/?p=799</guid>
		<description><![CDATA[<p>Signatures and the Law
When a person writes his name, that is his signature.  However, this is a relatively recent development in human history.  Beginning around 3 BC, documents were authenticated and made somewhat tamper resistant with wax seals that were imprinted with information that identified the author.  Signatures were usually made with a [...]]]></description>
			<content:encoded><![CDATA[<p><strong>Signatures and the Law</strong><br />
When a person writes his name, that is his signature.  However, this is a relatively recent development in human history.  Beginning around 3 BC, documents were authenticated and made somewhat tamper resistant with wax seals that were imprinted with information that identified the author.  Signatures were usually made with a stamp or signet ring which had raised impressions that could be inked and fixed to paper or wax.  The rings made pictures that varied from a cross to depictions of animals or buildings.  The use of initials or names gradually came into vogue.  In the 16th century, Phillip the Handsome of France adopted the simple signature and laws supporting the use of name only quickly became the law of the land.</p>
<p>A common definition of a signature is: a mark or sign made by an individual on a document to signify knowledge, approval, acceptance, or obligation.  I recall when I was in my 30’s creating a distinctive, artsy signature like you see on the U. S. Declaration of Independence.  I employed this bold signature for many years with gusto.  It was huge and overflowed all boundaries.  Over the years the number of times that I had to write my signature decreased substantially.  E-mail, banking on line and document work flow software contributed to this.  I also became aware that very few people even looked at my signature except for over eager seasonal retail clerks.  In fact, one recently questioned why my 6&#215;2 inch signature on a receipt looked different from the 3&#215;0.5 inch one on the back of my credit card. Duh!</p>
<p>I’ve noticed that more and more retail stores have installed hardware and software that has eliminated signatures on paper.  After you swipe your credit card, you make your mark on a touch screen with a special “pen”.  The legibility of my signature has virtually disappeared, but it doesn’t matter.  Making the mark signifies acceptance of the transaction and is legally binding.</p>
<p>The E-Sign Act validates electronic contracts in interstate and foreign commerce. The act does not apply to certain types of documents, including wills, Divorce notices, and documents that are associated with court proceedings.</p>
<p>A digital signature is based on cryptography, which uses mathematical formulas, or algorithms, to scramble messages. Using encryption and decryption software, the sender can scramble the message and the recipient can unscramble it. To affix a digital signature to an electronic document, a signer must obtain electronic &#8220;keys.&#8221; The keys are assigned in pairs: a private key and a public key.</p>
<p>A person creates his keys using a software program. The digital signature is affixed to the electronic document using the private key. The &#8220;signer&#8221; types in a password, similar to a personal identification number for an automatic teller machine. The private key then generates a long string of numbers and letters that represent the digital signature, or public key. The recipient of the message runs a software program using this public key to authenticate that the document was signed by the private key and that the document has not been altered during transmission.</p>
<p>It is mathematically infeasible for a person to derive another person&#8217;s private key. The only way to compromise a digital signature is to give another person access to the signature software and the password to the private key.</p>
<p>Will name signatures eventually go away?  Probably not for awhile.  But the act of composing the name certainly will.  We seem to be moving towards electronic signet rings and away from hand signed signatures.</p>
<hr />
<strong> What’s new?</strong></p>
<hr />
<strong> RECORDS &amp; ARCHIVING</strong><br />
DotGov, Inc. launched PageFreezer.com, a website archiving solution that complies with record management laws, benefiting governments, finance and public traded companies legally required to archive electronic data, including websites.<br />
PageFreezer is a web-based service that archives daily snapshots of websites. Website archives can be accessed by logging into the secured PageFreezer site from any computer, any time.<br />
Tracking all changes on the websites with PageFreezer offers these organizations trusted, non-refutable evidence in case of liability claims, which complies with public records laws, FINRA and SOX archiving regulations.</p>
<p>Autonomy Corporation plc announced the availability of Autonomy Social Media Governance, the industry&#8217;s first solution designed to monitor, govern, and protect organizations across social media channels. Autonomy Social Media Governance extends Autonomy&#8217;s market-leading supervision, policy, and compliance platform &#8211; used today by the world&#8217;s leadto enable businesses to maintain compliance with new regulatory requirements for employees engaging on social media sites.</p>
<p>Iron Mountain Incorporated announced its Mimosa NearPoint™solution is the first email archiving solution to be certified for the Dell™ DX Object Storage Platform. The newly launched Dell DX Object Storage Platform is an integrated hardware and software solution designed to efficiently access, store and distribute billions of files and other digital content. With the NearPoint solution, the unified content management offering will help organizations reduce the costs and risks of managing unstructured data from Microsoft® Exchange®.</p>
<p><strong>ELN / LIMS</strong></p>
<p>Rescentris, Inc. announced iPad and iPhone platform clients to extend mobile use of its award-winning CERF Electronic Laboratory Notebook (ELN). CERF is a scalable, cross-platform software solution that helps life sciences and other R&amp;D organizations migrate away from paper-based recordkeeping to increase efficiency and collaboration.</p>
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		<title>Paper vs Electronic</title>
		<link>http://theintegratedlab.com/2010/03/paper-vs-electronic-2/</link>
		<comments>http://theintegratedlab.com/2010/03/paper-vs-electronic-2/#comments</comments>
		<pubDate>Tue, 30 Mar 2010 14:42:51 +0000</pubDate>
		<dc:creator>John Trigg</dc:creator>
				<category><![CDATA[Compliance]]></category>
		<category><![CDATA[Document Management]]></category>
		<category><![CDATA[Legal]]></category>
		<category><![CDATA[Patents]]></category>
		<category><![CDATA[Records Retention]]></category>
		<category><![CDATA[ELN]]></category>
		<category><![CDATA[Note Taking]]></category>
		<category><![CDATA[Records management]]></category>

		<guid isPermaLink="false">http://theintegratedlab.com/?p=765</guid>
		<description><![CDATA[<p>In the relentless pursuit of increased efficiency and better productivity in our laboratories we turn to computers and automation to drive out inefficient human and paper-based processes.  So it was with some surprise that amongst my daily news feeds that keep me informed of the latest and greatest breakthroughs in laboratory matters, I came across [...]]]></description>
			<content:encoded><![CDATA[<p>In the relentless pursuit of increased efficiency and better productivity in our laboratories we turn to computers and automation to drive out inefficient human and paper-based processes.  So it was with some surprise that amongst my daily news feeds that keep me informed of the latest and greatest breakthroughs in laboratory matters, I came across a blog post by Benjamin Wilcox entitled ‘<a href="http://www.benjamintwilcox.com/introducing-exhibit-one-the-defendents-journal/" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.benjamintwilcox.com/introducing-exhibit-one-the-defendents-journal/?referer=');">Introducing Exhibit One, The Defendant&#8217;s Journal</a>’. The post offered detailed advice on keeping a (paper) notebook.  There were cross references two other posts, one by Tim Ferriss (&#8216;<a href="http://www.fourhourworkweek.com/blog/2007/12/05/how-to-take-notes-like-an-alpha-geek-plus-my-2600-date-challenge/" target="_self" onclick="pageTracker._trackPageview('/outgoing/www.fourhourworkweek.com/blog/2007/12/05/how-to-take-notes-like-an-alpha-geek-plus-my-2600-date-challenge/?referer=');">How to Take Notes Like an Alpha-Geek</a>&#8216;) and another by Jill Hubbard Bowman (&#8216;<a href="http://www.iplawforstartups.com/properly-documenting-the-creation-of-your-startups-ip/" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.iplawforstartups.com/properly-documenting-the-creation-of-your-startups-ip/?referer=');">Properly Documenting the Creation of Your Startup’s IP</a>&#8216;).</p>
<p>All three posts serve as a timely reminder that there are basic skills in some of the processes that we try to automate or computerise, and no amount of slick software can replace that.  But there were a few other points in the blog posts that could raise eyebrows.  I’m totally impressed by Tim Ferriss’ organisational skills and habits with paper notebooks, but there’s a lot of us who aren’t in his league.  And when it comes to any requirement for sharing&#8230;.I have to conclude that Tim’s notebooks are for his eyes only.</p>
<p>The other point that caught my attention was in Jill Hubbard Bowman’s post, which contains some great advice on recording and maintaining intellectual property; Jill made the point that ‘Courts don’t trust electronic documents’.  Well, this seems to run contradictory to a lot of the advice Lawyers and Patent Attorneys are passing on in organisations where paper lab notebooks are being replaced with electronic lab notebooks.  Since courts make decisions based on evidence, it is the relevance, integrity and authenticity of the evidence, not the medium, that determine trustworthiness.  Of course, the approach with digital records is different to that with paper records, but courts in the US and Western Europe are quite comfortable with electronic records, to the extent that most major pharmaceutical companies have switched to fully electronic records for their scientific IP.  But it does mean that a robust and reliable process for managing electronic records, able to stand up to the court’s scrutiny, is essential.  This throws a lot of emphasis on the underlying process; so the advice given in Jill’s post is very valid.</p>
<p>Here’s a couple of links to relevant posts on this site:<br />
<a href="http://theintegratedlab.com/2009/06/good-laboratory-notebook-practice/" target="_blank"> Good Laboratory Notebook Practice</a><br />
<a href="http://theintegratedlab.com/2009/10/legal-issues-of-elns/" target="_blank"> Legal Issues of ELNs</a></p>
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		<title>eOrganizedWorld Online Information Management Newsletter</title>
		<link>http://theintegratedlab.com/2010/03/eorganizedworld-online-information-management-newsletter-4/</link>
		<comments>http://theintegratedlab.com/2010/03/eorganizedworld-online-information-management-newsletter-4/#comments</comments>
		<pubDate>Fri, 26 Mar 2010 09:40:11 +0000</pubDate>
		<dc:creator>Charlie Sodano</dc:creator>
				<category><![CDATA[IP Protection]]></category>
		<category><![CDATA[Industry]]></category>
		<category><![CDATA[Records Retention]]></category>
		<category><![CDATA[newsletter]]></category>
		<category><![CDATA[Records management]]></category>

		<guid isPermaLink="false">http://theintegratedlab.com/?p=757</guid>
		<description><![CDATA[<p>The Fight for Space
I’m sure most of you have run into a situation that I’m facing.  I bought a new laptop 2 years ago with a 90 GB hard drive.  Actually you only get 88+ GB of usable space out of this kind of drive. I could have bought a bigger drive, but remember [...]]]></description>
			<content:encoded><![CDATA[<p><strong>The Fight for Space</strong><br />
I’m sure most of you have run into a situation that I’m facing.  I bought a new laptop 2 years ago with a 90 GB hard drive.  Actually you only get 88+ GB of usable space out of this kind of drive. I could have bought a bigger drive, but remember thinking, “there’s no way I’m going to run out of space before this PC is obsolete”.  Do you have any idea how many times I’ve said that over the years?  I didn’t even notice that I had gradually accumulated almost 80 GB of stuff.  My PCs performance was gradually falling off and I remember thinking that I needed to do some system tweaking.  That’s when I saw the overload.  It has been recommended to have a minimum of 10% of your hard drive available to be used as virtual memory.  The first fix was pretty easy, get rid of excess files, remove unused programs, running defrag, etc.  That lasted for a few months, now I’m back to where I was before.</p>
<p>I had preached before about the importance of having good external backups and disaster recovery systems.  My good works paid off when my 4 year old external terabyte drive died a few weeks ago.  I was also periodically burning DVDs, annually to preserve archive information in addition to keeping it on the terabyte drive.  I only lost a month of two of semi-important information in the end.</p>
<p>I found that the price and size of terabyte external drives had dropped enormously over the past few years so decided to buy 2 terabyte USB drives, keep them on-line all of time and structure my information warehouse, disaster recovery plan and PC hard drive management accordingly.</p>
<p>The first place to start is deciding what kinds of information do you really need to cart around on your PC no matter where you are.  This logic should be the same whether you have a home office like me or work in a corporate environment.</p>
<p>Let’s first consider your email files.  For many of us, this means Outlook.  Unless you constantly refer to old email information move your archive pst files off of your PC.  It is very easy to access in a repository if/when you need it.  We’ll talk more about other ways to manager your emails next month.  There is a lot to learn!</p>
<p>So do you really need to carry around ALL of your information?  Organize by year.  That way you can decide whether to carry around only new stuff and maybe some old stuff.  If you don’t have it sorted by year you will not have a choice.  No big trick here.  If you organize by year, then you will have to capability in the future to destroy old information too.  If you keep it in a big jumble, the percentage of worthless information will continue to accumulate.  And some day, you will run out of room, just like your attic or basement.</p>
<p>Getting back to disaster recovery, now that I have 2 external terabyte drives, I run my backups, using Microsoft utilities once a week writing to alternate drives.  All of my libraries and a system image are saved.  If one of the external drives goes kaput, I have the other.<br />
Yes I know that if my house blows up, all may be lost.  I’ll play the odds for now.  There are other redundancies I could work in like keeping a copy of my stuff in “the Cloud” but I really don’t want to go there.</p>
<p>My success story is that I now have control over how much I store on my PC.  The only factor that will change this is the installation new software.  When this occurs, I try to uninstall something that I rarely if ever use.</p>
<hr /><strong>What’s new?</strong></p>
<hr /><strong>Records Management / Archiving</strong><br />
Iron Mountain acquired Mimosa Systems, a provider of content archiving solutions.   The move gives Iron Mountain “on-premises” archiving and data protection capabilities, joining existing SaaS-based offerings.</p>
<p>Recent AIIM research (<a href="http://www.aiim.org/marketiq" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.aiim.org/marketiq?referer=');">http://www.aiim.org/marketiq</a>) found that 90% of organizations are using the PDF file format for long-term storage of scanned documents, and 89% are converting Office files to PDF for distribution and archive. Not surprisingly, paper is currently used by 100% of organizations, but when asked to predict the situation in 5 years time, use of paper for long-term storage dropped to 77%, whereas PDF rose to 93%.</p>
<p><strong>ELN / LIMS</strong><br />
The NeuroScholar Project is the flagship project for the Biomedical Knowledge Engineering Research Group at the Information Sciences Institute in Marina Del Rey.<br />
The NeuroScholar system is the flagship application of this project but they have developed other tools to be used in conjunction with the system. These deliver specialized functionality to a neuroscience knowledge user such as the &#8216;Electronic Laboratory Notebook&#8217; (ELN), support for schematic diagrams (Diagrammar) and neuroanatomical mapping functions (NeuARt II). The NAWS system is a method for using NeuroScholar to be able to run analyses on it&#8217;s contents as a remote webservice, and the Sangam project is concerned with intergrating information between different web services (of which NeuroScholar could be one). They have also built software engineering tools to assist with the construction of NeuroScholar-like knowledge bases. This subsystem is called the &#8216;View-Primitive Data Model framework&#8217; (VPDMf&#8217;).</p>
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		<title>Raw data</title>
		<link>http://theintegratedlab.com/2009/12/raw-data/</link>
		<comments>http://theintegratedlab.com/2009/12/raw-data/#comments</comments>
		<pubDate>Fri, 04 Dec 2009 10:39:30 +0000</pubDate>
		<dc:creator>John Trigg</dc:creator>
				<category><![CDATA[Compliance]]></category>
		<category><![CDATA[IP Protection]]></category>
		<category><![CDATA[Records Retention]]></category>
		<category><![CDATA[Requirements]]></category>
		<category><![CDATA[Records management]]></category>

		<guid isPermaLink="false">http://theintegratedlab.com/?p=681</guid>
		<description><![CDATA[<p>The subject of raw data has crept into the vocabulary of the media recently with alleged wrong doings amongst scientists in connection with data related to climate change.  The matter has unsurprisingly been dubbed ‘climategate’ and is currently chalking up over 28,000,000 hits on Google.  The underlying issues, if they are real, are political, and in [...]]]></description>
			<content:encoded><![CDATA[<p>The subject of raw data has crept into the vocabulary of the media recently with alleged wrong doings amongst scientists in connection with data related to climate change.  The matter has unsurprisingly been dubbed ‘climategate’ and is currently chalking up over 28,000,000 hits on Google.  The underlying issues, if they are real, are political, and in the normal spirit of popular news reporting, why let the data get in the way of a good story?  However, once you work your way through the political overtones, the issue does draw attention to something that must be close to the heart of any scientist, the preservation of data</p>
<p>Within the context of laboratory data and information management, raw data tends to draw out some interesting debate along the lines of what constitutes raw data, how and where do we store it, and for how long?</p>
<p>Those of us involved in the business of laboratory systems and laboratory integration can be kept pretty busy with the technological challenges of acquiring, managing and storing ever increasing volumes of raw data, but behind these challenges are some more fundamental questions that need to be answered before we can even start thinking about a solution.</p>
<p>So, if we assume that we know what the raw data is, the decision about how long we keep it is influenced by three different considerations.</p>
<p>Firstly, scientists are often hoarders of data and like to hang on to raw data as basic scientific evidence, for reference purposes,  or for re-assessment in the light of future scientific or technological advances. This requirement has no definable timeframe.</p>
<p>Secondly, there is an ethical position, largely determined by regulatory bodies, to allow for the re-examination of data in the light of the consequences of unforeseen defects, failures or adverse effects of products or processes.  This timeframe may be determined by, or related to the lifetime of the product or process.</p>
<p>Thirdly, there is a business requirement to address IP protection in terms of the underlying value of the data to the business.  This may have a long timeframe if it is relevant to a patent, but could in other circumstances have a relatively short timeframe.</p>
<p>Making the decision on what to store and for how long has its complexities, but the combination of regulatory and legal guidance, business best practice, good technology and hopefully, common sense, is helping shape a way forward.  However, it is always good to remember that the scientific knowledge food-chain starts with the raw data, and an item by Derek Lowe (<a href="http://pipeline.corante.com/archives/2009/12/02/data_raw_and_otherwise.php" target="_blank" onclick="pageTracker._trackPageview('/outgoing/pipeline.corante.com/archives/2009/12/02/data_raw_and_otherwise.php?referer=');">Data, Raw and Otherwise</a>), loosely connected to ‘Climategate’ on <a href="http://pipeline.corante.com/" target="_blank" onclick="pageTracker._trackPageview('/outgoing/pipeline.corante.com/?referer=');">In the Pipeline</a> serves as a good reminder of the importance of raw data from the scientist’s perspective.</p>
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		<title>Tales from the Crypt, part deux</title>
		<link>http://theintegratedlab.com/2009/07/tales-from-the-crypt-part-deux/</link>
		<comments>http://theintegratedlab.com/2009/07/tales-from-the-crypt-part-deux/#comments</comments>
		<pubDate>Thu, 09 Jul 2009 17:51:43 +0000</pubDate>
		<dc:creator>Sebastien Dupuis</dc:creator>
				<category><![CDATA[Compliance]]></category>
		<category><![CDATA[Document Management]]></category>
		<category><![CDATA[Implementation]]></category>
		<category><![CDATA[Records Retention]]></category>
		<category><![CDATA[Regulatory]]></category>

		<guid isPermaLink="false">http://theintegratedlab.com/?p=347</guid>
		<description><![CDATA[<p>Hello everyone! As a new contributor to The Integrated Lab and my first time ever writing a blog entry, I was wondering how I would start contributing to the site and also how do you blog?</p>
<p>John&#8217;s earlier post &#8220;Tales from the Crypt&#8221; gave me that answer: Document Management.  Having done some projects related to document management, [...]]]></description>
			<content:encoded><![CDATA[<p><span style="font-family: Calibri;">Hello everyone! As a new contributor to The Integrated Lab and my first time ever writing a blog entry, I was wondering how I would start contributing to the site and also how do you blog?</span></p>
<p><span style="font-family: Calibri;">John&#8217;s earlier post <a href="http://theintegratedlab.com/2009/06/tales-from-the-crypt">&#8220;Tales from the Crypt&#8221;</a> gave me that answer: Document Management.  Having done some projects related to document management, I thought I could contribute with what I know.</span></p>
<p><span style="font-family: Calibri;">A good example supporting John&#8217;s point (and I&#8217;m sure it happened to others out there!) is when the lab I worked in at the time (around 1997-98) decided to upgrade our old HPLC&#8217;s controlled by PC&#8217;s with Windows 3.1 and the Chromatography software installed.  All instrument and software validation had gone well and we were up and running on the new systems when came the day where we had to review and reprint some older data.  Oops, we couldn&#8217;t retrieve the old data on the newer software.  Fortunately, we had kept the PC&#8217;s aside just for that.</span></p>
<p><span style="font-family: Calibri;">A laboratory, or any organization for that matter, can store all the information it wants but if there&#8217;s no way to read that data at a later point in time, storing that data is useless.  Organizations need a well-defined strategy for managing their documents and electronic records.</span></p>
<div><span style="font-family: Calibri;"><a href="http://www.aiim.org/" onclick="pageTracker._trackPageview('/outgoing/www.aiim.org/?referer=');">AIIM</a> is a good place to start when it comes to documents and records management.  They provide a lot of information on best practices as well as training on how to implement a documents and records management strategy.</span></div>
<div></div>
<p><span style="font-family: Calibri;"></p>
<div><span style="font-family: Calibri;">One of the things AIIM has been doing in the last few years is pushing for the adoption of the PDF standard, which was <a href="http://www.iso.org/iso/pressrelease.htm?refid=Ref1141" onclick="pageTracker._trackPageview('/outgoing/www.iso.org/iso/pressrelease.htm?refid=Ref1141&amp;referer=');">finally adopted last year</a>.  This adoption is a big step forward and details are available if you look for ISO 32000-1:2008 and is freely available <a href="http://www.adobe.com/devnet/acrobat/pdfs/PDF32000_2008.pdf" onclick="pageTracker._trackPageview('/outgoing/www.adobe.com/devnet/acrobat/pdfs/PDF32000_2008.pdf?referer=');">here</a>.</span></div>
<p> </p>
<p></span></p>
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		<title>Tales from the Crypt</title>
		<link>http://theintegratedlab.com/2009/06/tales-from-the-crypt/</link>
		<comments>http://theintegratedlab.com/2009/06/tales-from-the-crypt/#comments</comments>
		<pubDate>Mon, 29 Jun 2009 15:18:07 +0000</pubDate>
		<dc:creator>John Trigg</dc:creator>
				<category><![CDATA[Document Management]]></category>
		<category><![CDATA[Industry]]></category>
		<category><![CDATA[Records Retention]]></category>
		<category><![CDATA[Requirements]]></category>
		<category><![CDATA[e-discovery]]></category>
		<category><![CDATA[Records management]]></category>

		<guid isPermaLink="false">http://theintegratedlab.com/?p=322</guid>
		<description><![CDATA[<p>It’s hardly the most exciting subject, but long term retention is one of those topics that seem to lurk in the background whenever the subject of electronic records comes up.  With several centuries experience behind us, we’ve learned quite a bit about preserving paper records; Leonardo Da Vinci wrote his notes over 500 years ago, and [...]]]></description>
			<content:encoded><![CDATA[<p>It’s hardly the most exciting subject, but long term retention is one of those topics that seem to lurk in the background whenever the subject of electronic records comes up.  With several centuries experience behind us, we’ve learned quite a bit about preserving paper records; <a href="http://www.bl.uk/onlinegallery/features/leonardo/ttp.html" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.bl.uk/onlinegallery/features/leonardo/ttp.html?referer=');">Leonardo Da Vinci</a> wrote his notes over 500 years ago, and we can still read them, but ask someone whether it will be possible to read our electronic laboratory records in 500 years time, and the answers can get a bit evasive.  Since laboratories started the digital journey, we’ve probably all got some sad and sorry tales of data loss.  Proprietary data formats, redundant applications, new forms of digital media, not to mention the failure to recover from hardware problems because you just didn’t get round to doing the backups have all conspired to create gaps in our record systems.  In fact there is a fear that the early years of the ‘information age’ may come to be looked upon as a ‘<a href="http://en.wikipedia.org/wiki/Digital_Dark_Age" target="_blank" onclick="pageTracker._trackPageview('/outgoing/en.wikipedia.org/wiki/Digital_Dark_Age?referer=');">digital dark age</a>’, as our enthusiasm to embrace new technologies has raced ahead of our diligence in ensuring the preservation of their output.</p>
<p>One of the more significant stories has been the problems with the NASA records from the early space program.   I came across this article <a href="http://pcworld.co.nz/pcworld/pcw.nsf/feature/7A6BCA446DC440D5CC2575E4001CDB07" target="_blank" onclick="pageTracker._trackPageview('/outgoing/pcworld.co.nz/pcworld/pcw.nsf/feature/7A6BCA446DC440D5CC2575E4001CDB07?referer=');">The lost NASA tapes: Restoring lunar images after 40 years in the vault</a> which describes some of the superhuman effort involved in reclaiming important data that may otherwise be lost forever.  The data may probably be a bit more significant than some of the stuff we have in our labs, but who knows?  But this is exactly the scenario that a good records management process and a good records’ manager has to save us from.  If Records Managers become the heroes of the 21st century, so be it!</p>
<p>The NASA story makes interesting reading and raises the question ‘it couldn’t happen to us, could it?’  An earlier item from Charlie Sodano  <a href="http://theintegratedlab.com/2009/04/getting-started-with-records-management/" target="_blank">Getting Started with Records Management</a>, was posted to draw attention to the problems and how to make a start on solving it.  And the big question is, how ready are we now?  It’s not unusual to come across surveys quoting the number of companies who feel they have a robust records management strategy in place being frighteningly low.  Unfortunately, investing in records management doesn’t show a plus on the bottom line…..but if disaster strikes, then it can prevent a very big minus.  Just like buying an insurance policy, really.</p>
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		<title>Six Risks to Intellectual Property</title>
		<link>http://theintegratedlab.com/2009/06/six-risks-to-intellectual-property/</link>
		<comments>http://theintegratedlab.com/2009/06/six-risks-to-intellectual-property/#comments</comments>
		<pubDate>Mon, 08 Jun 2009 10:22:11 +0000</pubDate>
		<dc:creator>John Trigg</dc:creator>
				<category><![CDATA[Compliance]]></category>
		<category><![CDATA[Document Management]]></category>
		<category><![CDATA[IP Protection]]></category>
		<category><![CDATA[Legal]]></category>
		<category><![CDATA[Patents]]></category>
		<category><![CDATA[Records Retention]]></category>
		<category><![CDATA[NGP]]></category>
		<category><![CDATA[Partnerships]]></category>

		<guid isPermaLink="false">http://theintegratedlab.com/?p=228</guid>
		<description><![CDATA[<p>One of the big challenges for research laboratories is getting the balance right between &#8216;need to know&#8217; and &#8216;want to know&#8217;.  Most scientists will fall into the later category; after all, innovation depends on an inquisitive mind, and an open and sharing environment should act as a stimulus for discovery.  On the other side of the [...]]]></description>
			<content:encoded><![CDATA[<p>One of the big challenges for research laboratories is getting the balance right between &#8216;need to know&#8217; and &#8216;want to know&#8217;.  Most scientists will fall into the later category; after all, innovation depends on an inquisitive mind, and an open and sharing environment should act as a stimulus for discovery.  On the other side of the equation is the question of the security and protection of intellectual property.  These two scenarios create a paradox that presents a social and technical challenge.  <a href="http://www.linkedin.com/pub/jeff-spitzner/0/821/715" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.linkedin.com/pub/jeff-spitzner/0/821/715?referer=');">Jeff Spitzner</a> recently wrote an article for NGP (<a href="http://www.ngpharma.eu.com/" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.ngpharma.eu.com/?referer=');">New Generation Pharmaceutical</a>) Magazine (<em>requires a free subscription</em>) entitled <a href="http://www.ngpharma.eu.com/article/Issue-7/Research-AND-Development/Six-risks-to-intellectual-property/" target="_blank" onclick="pageTracker._trackPageview('/outgoing/www.ngpharma.eu.com/article/Issue-7/Research-AND-Development/Six-risks-to-intellectual-property/?referer=');">Six Risks to Intellectual Property</a>, which specifically addresses this paradox in the context of parnerships in the drug development lifecycle, and pinpoints the necessity of protecting investments by enforcing adequate procedural and technical controls.</p>
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		<title>Getting Started with Records Management</title>
		<link>http://theintegratedlab.com/2009/04/getting-started-with-records-management/</link>
		<comments>http://theintegratedlab.com/2009/04/getting-started-with-records-management/#comments</comments>
		<pubDate>Tue, 28 Apr 2009 14:20:57 +0000</pubDate>
		<dc:creator>Charlie Sodano</dc:creator>
				<category><![CDATA[Records Retention]]></category>
		<category><![CDATA[Records]]></category>
		<category><![CDATA[Records management]]></category>

		<guid isPermaLink="false">http://theintegratedlab.com/?p=115</guid>
		<description><![CDATA[<p class="MsoPlainText">Are you responsible for managing a collection of records that are currently stored in filing cabinets, boxes, computers and servers? Is the collection growing rapidly? Do you feel that no one really cares, except when there’s a legal or regulatory action?</p>
<p class="MsoPlainText">You are not alone. Even with all of the publicity about companies getting into [...]]]></description>
			<content:encoded><![CDATA[<p class="MsoPlainText"><span style="font-size: 12pt; font-family: &quot;Garamond&quot;,&quot;serif&quot;;">Are you responsible for managing a collection of records that are currently stored in filing cabinets, boxes, computers and servers?<span> </span>Is the collection growing rapidly?<span> </span>Do you feel that no one really cares, except when there’s a legal or regulatory action?</span></p>
<p class="MsoPlainText"><span style="font-size: 12pt; font-family: &quot;Garamond&quot;,&quot;serif&quot;;">You are not alone.<span> </span>Even with all of the publicity about companies getting into trouble because they had inadequate records programs, records management still does not get much respect.</span></p>
<p class="MsoPlainText"><span style="font-size: 12pt; font-family: &quot;Garamond&quot;,&quot;serif&quot;;"> </span></p>
<p class="MsoPlainText"><span style="font-size: 12pt; font-family: &quot;Garamond&quot;,&quot;serif&quot;;">Many people fall into the habit of doing as little organizing as possible, hoping that nothing bad will happen during their watch.<span> </span>I have that attitude about earthquakes in California, where I live.<span> </span>The downside is that if something bad does happen, you will be overwhelmed and may resort to half-truths to get through the ordeal.<span> </span></span></p>
<p class="MsoPlainText"><span style="font-size: 12pt; font-family: &quot;Garamond&quot;,&quot;serif&quot;;">It doesn’t have to be like this, especially if your record collection is only a few years old.<span> </span>Even if it’s older you can plan and implement a program for new records, then gradually incorporate your legacy collection.</span></p>
<p class="MsoPlainText"><span style="font-size: 12pt; font-family: &quot;Garamond&quot;,&quot;serif&quot;;"> </span></p>
<p class="MsoPlainText"><span style="font-size: 12pt; font-family: &quot;Garamond&quot;,&quot;serif&quot;;">Here’s what to do to get started.<span> </span>Compose a simple listing of all records in an Excel spreadsheet.<span> </span>Come up with 5-10 general categories’ and assign each record to one of them via a new Excel column.<span> </span>You may have one category called “unknown”.<span> </span>That’s OK.<span> </span>You can spend time in the future sorting out what these records really are.<span> </span></span></p>
<p class="MsoPlainText"><span style="font-size: 12pt; font-family: &quot;Garamond&quot;,&quot;serif&quot;;"> </span></p>
<p class="MsoPlainText"><span style="font-size: 12pt; font-family: &quot;Garamond&quot;,&quot;serif&quot;;">With the help and assistance of the record author/owners determine a retention schedule for each category.<span> </span>Some research will probably be necessary to identify records that have to be kept for legal or regulatory purposes.<span> </span>Business needs are usually the most significant factor in establishing retention.<span> </span>You should NEVER keep records permanently unless they have historical significance.<span> </span>I recommend that the maximum retention should be no more than 50 years.<span> </span>All records should be reviewed at the end of their retention to determine whether they need to be retained longer, destroyed or reclassified.<span> </span>I have heard good arguments about keeping some type of records permanently.<span> </span>The problem with this way of thinking is the assumption that nothing will change over the next 50 years.<span> </span>And we know that things do change.<span> </span>Companies get bought and sold, laws change, policies change, etc.<span> </span>Historically significant records should be moved to a different repository and managed separately.</span></p>
<p class="MsoPlainText"><span style="font-size: 12pt; font-family: &quot;Garamond&quot;,&quot;serif&quot;;"> </span></p>
<p class="MsoPlainText"><span style="font-size: 12pt; font-family: &quot;Garamond&quot;,&quot;serif&quot;;">Record categories and retention schedules should be reviewed annually.<span> </span>Laws, regulations and business needs constantly change.<span> </span>It’s not cheap to store records.<span> </span>Get rid of them as soon as possible.<span> </span>One box of paper records can cost you upwards of $30 a year.<span> </span>Electronic record storage also is not inexpensive.<span> </span>The total cost of storing a gigabyte of information on a secure network server is about $30 a year.</span></p>
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