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	<title>Sitrof Technologies &#187; 21 CFR Part 11</title>
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	<link>http://sitrof.com</link>
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		<title>A trusted partner through the content migration process</title>
		<link>http://sitrof.com/resources/insights/life-sciences-content-migration-part-11-compliance/</link>
		<comments>http://sitrof.com/resources/insights/life-sciences-content-migration-part-11-compliance/#comments</comments>
		<pubDate>Tue, 31 Jan 2012 21:23:28 +0000</pubDate>
		<dc:creator>Sitrof</dc:creator>
				<category><![CDATA[Insights]]></category>
		<category><![CDATA[21 CFR Part 11]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[Content migration]]></category>
		<category><![CDATA[Document Management]]></category>
		<category><![CDATA[ECM]]></category>

		<guid isPermaLink="false">http://sitrof.com/?p=3824</guid>
		<description><![CDATA[There are nearly as many reasons for life sciences companies to perform content migrations as there are life sciences companies. A merger or acquisition often necessitates the process. But it could be a lack of support for legacy systems, or the increased cost of maintaining old hardware overshadowing the cost of migration. It could simply [...]]]></description>
			<content:encoded><![CDATA[<h3>There are nearly as many reasons for life sciences companies to perform content migrations as there are life sciences companies.</h3>
<h4>A merger or acquisition often necessitates the process. But it could be a lack of support for legacy systems, or the increased cost of maintaining old hardware overshadowing the cost of migration. It could simply be the desire to switch to a less expensive document management solution.</h4>
<p>In any case, running multiple document management systems parallel to one another is not an option – such a situation is confusing to end users, resulting in a productivity drain. Plus, IT expenses skyrocket as maintenance time increases and hard costs rise.</p>
<p>Analyzing processes, planning the transition, getting buy-in from staff, implementing the changes – who can companies trust to get it done right the first time? For more than a decade, Sitrof has performed complex migrations for Fortune 100 companies, successfully migrating content from a variety of sources to different target repositories. With a special focus on life sciences companies and regulated environments (including those governed by FDA 21 CFR Part 11), Sitrof is the trusted provider for complex content migrations.</p>
<h4>The Sitrof Approach</h4>
<p>Backed by years of life sciences experience and world-class software industry partnerships, Sitrof is the industry leader in vendor-neutral system integration services.</p>
<p>No two migrations are the same. Sometimes, an off-the-shelf migration tool – like Buldoser or FME’s migration-center – can get the job done. Sometimes, a custom solution is necessary. Sitrof offers best-of-breed solutions when it comes to either approach – or a combination of the two.</p>
<p>Recently, a large generic pharmaceutical manufacturer needed to migrate a subset of documents from their legacy GxPharma solution to a FirstDoc FDQM 5.0 system. The company elected to use CSC Configuration Management Utility to perform the migration, but a unique set of complicating factors required a unique solution. The GxPharma system was running Documentum version 4.2.8, while the FDQM system was running Documentum version 6.0 SP1. Because CMU 5.0 uses DFC 6.0 SP1 and cannot connect to a 4.28 repository, Sitrof issued CMU 4.2 to perform the export while using CMU 5.0 to perform the import and post-import processing steps.</p>
<p>Essentially, if a company owns a migration utility, Sitrof can use it. If a company does not, Sitrof can custom-create a solution based on need and cost. Any migration is possible – one system to one system, one system to many systems or many systems to one system. With years of experience moving data into and out of FirstDoc, Documentum, SharePoint, FileNet and DocuShare, Sitrof has the wide-ranging expertise it takes to get the job done.</p>
<h4>The Sitrof Process</h4>
<p>Sitrof-engineered migrations begin with an in-depth discovery process. By first determining the scope of the project and the tools necessary, Sitrof can, in many cases, even <a href="http://sitrof.com/solutions/fixed-price-content-migration-from-sitrof/">offer an upfront fixed price</a>.</p>
<p>One recent merger brought together two leading life sciences companies – with five distinct document management systems between them. Sitrof identified the requirements for migrating each into the target system, and standardized naming protocols and security procedures. By the time the actual migration started, careful planning had mitigated the risk of unpleasant surprises and bottlenecks. In the end, the complex migration and validation of terabytes’ worth of regulated content proceeded smoothly.</p>
<p>Sitrof’s proven process allows it to migrate a company’s data, content and metadata, no matter how many repositories they have or need. Just as importantly, Sitrof guarantees all migrations are performed successfully through strict validation requirements. Whether it’s a large customer with a set migration methodology or a smaller client in need of consultation, Sitrof ensures FDA and EMA compliance, no matter how rigorous the regulatory requirements.</p>
<h4>Don’t go it alone</h4>
<p>Trying to complete a migration project in-house can seem attractive from a cost and effort perspective – at first. While the actual migration process – moving documents from Location X to Location Y – seems relatively straightforward, what surrounds it is not. A migration is a golden opportunity to streamline and cleanse systems of outdated and unnecessary documents and files. Without the right people, processes and methodology, businesses can struggle to fully leverage the opportunities a migration provides.</p>
<p>Whatever the reason for undergoing the process, Sitrof offers life sciences companies maximum return on their migration investment, as well as proven, trustworthy, validated solutions for all client sizes.</p>
<p><em>Dan Wheeler is a managing partner and co-founder of <a href="http://www.sitrof.com">Sitrof Technologies</a>, 700 Alexander Park, Princeton, N.J. 08540.</em></p>
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		<title>E-Document Collaboration During The Clinical Trial Process</title>
		<link>http://sitrof.com/resources/insights/e-document-collaboration-during-the-clinical-trial-process/</link>
		<comments>http://sitrof.com/resources/insights/e-document-collaboration-during-the-clinical-trial-process/#comments</comments>
		<pubDate>Tue, 27 Dec 2011 20:03:33 +0000</pubDate>
		<dc:creator>Sitrof</dc:creator>
				<category><![CDATA[Case Studies]]></category>
		<category><![CDATA[Insights]]></category>
		<category><![CDATA[Published Articles]]></category>
		<category><![CDATA[21 CFR Part 11]]></category>
		<category><![CDATA[Document Management]]></category>
		<category><![CDATA[ECM]]></category>
		<category><![CDATA[SharePoint]]></category>

		<guid isPermaLink="false">http://sitrof.com/?p=3776</guid>
		<description><![CDATA[The benefits of peer-to-peer networking over email, fax, FTP or hosted third-party services  The need for life sciences companies to collaborate with external partners, whether it’s Legal Counsel, Contract Research Organizations (CRO’s), Manufacturers or Joint Venture partners, has become a daily occurrence. Documents such as Contracts, Informed Content and Protocols require authoring, review and approval [...]]]></description>
			<content:encoded><![CDATA[<h3>The benefits of peer-to-peer networking over email, fax, FTP or hosted third-party services</h3>
<h4> The need for life sciences companies to collaborate with external partners, whether it’s Legal Counsel, Contract Research Organizations (CRO’s), Manufacturers or Joint Venture partners, has become a daily occurrence. Documents such as Contracts, Informed Content and Protocols require authoring, review and approval from individuals both inside and outside the company. This trend will continue as life sciences companies increase outsourcing efforts at the same time the amount of unstructured content generated each year skyrockets.1</h4>
<p>There are many different use cases in the clinical trial process that require the need for this type of data exchange. For example, Investigator’s Brochures (IB) are exchanged between study sponsors, investigators and Institutional Review Boards (IRB). These are not static documents thus requiring collaboration as updates are needed whenever new relevant information is found during a trial. Creating, reviewing and approving Informed Consent language requires a collaborative process that involves input from investigators and IRBs. Investigators are required to complete a Form 1572 along with a summary of their qualifications (typically a CV) and provide it to the sponsor before participating in a trial.</p>
<p>Documents such as these are vital to the safety and efficient operation of a clinical study. Failure to have a reliable, consistent and compliant approach to document exchange and collaboration with relevant parties can result in unnecessary delays and additional costs</p>
<h4>Challenges with Common Document Sharing Methods</h4>
<p>Many CROs and life sciences companies today collaborate and exchange content either through email, fax, File Transfer Protocol (FTP) or hosted third-party solutions. Each of these methods has its disadvantages in terms of security, document versioning, cost, efficiencies and information loss.</p>
<h4>Email</h4>
<p>For example, email may be easy to use, and is by far the most widely used communication mechanism in the corporate world. However, sending attachments through email is typically not secure because most of us aren’t encrypting attachments. Attachments also cause our mailboxes to quickly exceed their quota. More troublesome is the fact that there is often confusion about which version of the attachment is the latest—a problem that is exacerbated as the number of collaborating users increases. The end result is a time-consuming, frustrating and error-prone process of manually merging multiple documents to ensure the latest edits and comments are incorporated into a single document.</p>
<h4>Fax</h4>
<p>Like email, facsimile technologies are commonplace in the workplace. Most fax solutions today convert incoming faxes to digital format and email the document to the recipient. This may be sufficient if the receiver does not need to modify the document. However, in a collaborative environment—where both the sender and receiver must author or edit the document—the resulting PDF or TIFF file is not an editable document and is unsuitable for this purpose.</p>
<h4>FTP</h4>
<p>FTP collaboration, while not as commonly used as email or fax, has a long history of providing a secure means of exchanging files. However, these solutions require more advanced technical knowledge, are cumbersome to use and typically require IT involvement to initially set up and configure permissions and access. Security aside, the lack of version management is as much a problem with FTP as it is with email.</p>
<h4>Third-Party Solutions</h4>
<p>Some hosted third-party ("on-demand") solutions solve some of the problems of email and fax by providing a common repository for all parties so there should be no question about which version of the document is the latest. Features such as document version control are useful in that you can go back to an old version of a particular document and have greater insight into how the document has changed throughout the collaborative process. However, not all on-demand solutions offer versioning features, including one of the leading solutions on the market. Some on-demand solutions do provide audit capabilities. This provides for better compliancy by tracking the user, date and time for each document change.</p>
<p>On-demand solutions have a potentially large cost downside, however. These services typically charge by the number of documents or the amount of storage space consumed. As such, they can quickly become expensive. In addition, these solutions require a username and password to connect, which is typically not synchronized with the user’s network username and password. This requires users to remember yet another username and password. This in turn leads to security and compliance issues—for example, users have been known to write passwords on a sticky note and keep it under their keyboard.</p>
<h4>Peer-to-Peer Data Sharing: The Ideal Solution</h4>
<p>The drawbacks associated with all of these methods—some of which are quite serious—has escalated the need to find a more secure, cost-effective and user-friendly way to manage documents. The solution at hand is peer-to-peer data sharing, one of the most effective content delivery methods available today. Peer-to-peer is an approach to computer networking where all computers share equivalent responsibility for processing data.</p>
<p>Of course, there is one critical consideration to make when selecting a document exchange and collaboration solution: Above all, it must be easy for the end-user to use. This speeds adoption of the new process, avoids costly upfront and ongoing training costs and eliminates the all-too-common scenario where end-users revert back to using email to share documents.</p>
<h4>Lower Cost, Improved Performance</h4>
<p>Peer-to-peer networking (also known simply as peer networking) differs from client-server networking, where certain devices have responsibility for "serving" the data and other devices consume or otherwise act as "clients" of those servers.</p>
<p>Peer networking significantly reduces technology costs for file sharing while dramatically improving the performance and scalability of the document creation, maintenance and review process. It allows organizations to seamlessly add speed and efficiency for content collaboration, while requiring no changes to the business's current technology infrastructure. This greatly improves the end-user experience and securely speeds up the process of document collaboration for both internal and external parties.</p>
<p>In a peer networking solution, desktop computers can easily be configured to allow sharing of files, printers and other resources across all connected devices, allowing data to be shared easily in both directions—whether downloads to or uploads from your computer. Peer networking can also handle a very high volume of file sharing traffic because the load is distributed across many computers.</p>
<h4>Improved Security</h4>
<p>Because trial-related documents contain proprietary information and/or sensitive patient data, improved security is a must. For example, if a CRO is working with three separate life sciences companies, it is important, from both a compliance and contractual standpoint, to have three separate workspaces to reduce the risk that a confidential document from Life Sciences Company A is not seen by Life Sciences Company B. Peer networking documents that are exchanged between any two parties are stored within their own individual workspace.</p>
<p>An effective peer network also automatically encrypts and replicates data among users, allowing every user to have constant access to the latest shared documents—even if they are not online. It is also important for the solution to encompass built-in disaster recovery by having the data stored in at least two separate locations.</p>
<h4>Accurate Version Control and Tracking</h4>
<p>Peer networking should allow CROs to track and manage documents in several ways, including version control and status change notifications via email or text. Additionally, automatic status update indicators should be displayed to alert users of new updates within the application interface. This allows for real-time interaction and updates among users, ensuring a more efficient and accurate collaboration process.</p>
<h4>Cost-Effective Infrastructure</h4>
<p>One of the most important benefits of a peer networking solution is the elimination of the storage and file-transfer costs typically associated with on-demand services. The ideal peer networking solution requires minimal end-user training and greatly reduces administration, resources and maintenance from a central IT infrastructure, lowering overall costs and accelerating the investment payback.</p>
<h4>Integration with Existing Document Management Systems</h4>
<p>An exchange and collaboration solution should allow for integration with an existing document management system. For example, take the scenario where an Investigator’s Brochures (IB) is initially created. The authoring and review should happen in a collaborative workspace but, once complete, it should be moved seamlessly into a document management system (DMS) such as Documentum or SharePoint where it can go through a formal approval process with electronic signatures. When the IB needs to be modified at a later date, a change request should be submitted, and once approved, the IB should seamlessly be copied back into the collaborative workspace. Then the IB can be modified by all relevant parties. After the IB is revised, it should be moved or published back into the DMS.</p>
<h4>Universal Platform Support</h4>
<p>As the Apple Mac is gaining popularity in the corporate world, any peer networking solution should be innately compatible with both Windows and Mac computers.</p>
<h3>Conclusion</h3>
<p>The most common methods of document sharing and collaboration in use today—predominantly email, fax and FTP—are inadequate and insecure. Expensive managed third-party solutions may also be insufficient, particularly for highly regulated life sciences needs.</p>
<p>A good peer networking solution, on the other hand, will allow life science companies and CROs to balance multiple factors such as total cost of ownership (TCO), ease of use, robust version control capabilities, auditing and integration into a true document management system. The end result: a comprehensive solution with improved workflow, 21 CFR Part 11 compliant electronic signatures, change management and records retention capabilities.</p>
<p>Life sciences companies that adopt peer networking will experience improved document exchange and collaboration processes with external business partners. This reduces risk, compliance and security issues, while at the same time promoting efficiencies and cost savings. CROs that offer robust exchange and collaboration solutions using peer networking also stand to gain a competitive advantage while providing benefit back to their life sciences customers. In turn, these customers will be able to launch products faster because the document-intensive clinical trial and submission management processes are streamlined and made more secure.</p>
<p>&nbsp;</p>
<p>1 J. Malek, Transforming Life Sciences: The Connected Life Sciences Company,</p>
<p>Cisco Internet Business Solutions Group (IBSG), July 2009</p>
<p>2 Peer-to-Peer, Harnessing the Power of Disruptive Technologies, March 2001</p>
<p>Dan Wheeler is a managing partner and co-founder of Sitrof Technologies, 700 Alexander Park, Princeton, NJ 08540</p>
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		<title>DIA 47th Annual Meeting-What we saw!</title>
		<link>http://sitrof.com/resources/insights/dia-recap/</link>
		<comments>http://sitrof.com/resources/insights/dia-recap/#comments</comments>
		<pubDate>Thu, 30 Jun 2011 13:57:16 +0000</pubDate>
		<dc:creator>Sitrof</dc:creator>
				<category><![CDATA[Insights]]></category>
		<category><![CDATA[21 CFR Part 11]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[DIA Annual Meeting]]></category>
		<category><![CDATA[linkedin]]></category>
		<category><![CDATA[Microsoft SharePoint]]></category>

		<guid isPermaLink="false">http://sitrof.com/?p=3206</guid>
		<description><![CDATA[We just arrived back from the 47th annual DIA meeting in Chicago. We spent our time meeting up with colleagues and friends, learning, and finding out what’s new in the industry. Sitrof was glad to hear that DDMAC submissions will be accepted in eCTD format by the FDA by 2012. Our product, Approve-PTS will be [...]]]></description>
			<content:encoded><![CDATA[<p>We just arrived back from the 47th annual DIA meeting in Chicago. We spent our time meeting up with colleagues and friends, learning, and finding out what’s new in the industry.</p>
<p>Sitrof was glad to hear that DDMAC submissions will be accepted in eCTD format by the FDA by 2012. Our product, <a href="http://sitrof.com/products/approve-pts/">Approve-PTS</a> will be enhanced to support this. Approve-PTS, built on Microsoft SharePoint 2010, connects outside creative agencies, marketing teams and regulatory reviewer--allowing marketing materials to get reviewed, approved and published in the most efficient manner possible.</p>
<p>Speaking of Microsoft, we saw their huge display booth along with NextDocs and Liquent – their offerings look good and traffic was high at all three booths.  We imagine booth traffic was higher for these vendors since both EMC (IIG) and CSC were not in attendance.</p>
<p>As expected, a lot of sessions and vendors were talking about the cloud.  In the content management space, companies like Box and SpringCM are gaining traction but it’s clear the life sciences industry is not ready to put their GxP related documentation in the cloud without it first being validated.  Vevva Systems is looking to change that with their <a href="http://veevasystems.com/vault/">Vault solution</a> which is a cloud enabled content management solution built from the ground up with the Life Sciences industry in mind.  It will be interesting to see how this solution can compete with traditional on-premise solutions like Documentum and SharePoint</p>
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		<title>Sitrof Technologies featured in Applied Clinical Trials cover story</title>
		<link>http://sitrof.com/resources/insights/sitrof-technologies-featured-in-applied-clinical-trials-cover-story/</link>
		<comments>http://sitrof.com/resources/insights/sitrof-technologies-featured-in-applied-clinical-trials-cover-story/#comments</comments>
		<pubDate>Mon, 20 Jun 2011 16:24:23 +0000</pubDate>
		<dc:creator>Sitrof</dc:creator>
				<category><![CDATA[Insights]]></category>
		<category><![CDATA[Published Articles]]></category>
		<category><![CDATA[21 CFR Part 11]]></category>
		<category><![CDATA[Best Practices]]></category>
		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[Document Management]]></category>
		<category><![CDATA[DocuShare Compliance Module]]></category>
		<category><![CDATA[linkedin]]></category>
		<category><![CDATA[Xerox DocuShare]]></category>

		<guid isPermaLink="false">http://sitrof.com/?p=3130</guid>
		<description><![CDATA["Innovation in Ethical Review," an article authored by Sitrof client Jennifer Sodrel, Director of Information Management at CGIRB, is featured the cover of the May issue of Applied Clinical Trials. Sodrel’s article is based on CGIRB’s transition to a fully paperless company, a process that started in mind-2008 when CGRIB teamed with Sitrof Technologies to [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/IT+Articles/Innovation-in-Ethical-Review/ArticleStandard/Article/detail/719558?contextCategoryId=43496"><img class="alignleft size-full wp-image-3131" title="Applied-Clinical-Trials" src="http://sitrof.com/wp-content/uploads/2011/06/Applied-Clinical-Trials.jpg" alt="" width="101" height="136" /></a><a href="http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/IT+Articles/Innovation-in-Ethical-Review/ArticleStandard/Article/detail/719558?contextCategoryId=43496" target="_blank">"Innovation in Ethical Review,"</a> an article authored by Sitrof client Jennifer Sodrel, Director of Information Management at CGIRB, is featured the cover of the May issue of Applied Clinical Trials.</p>
<p>Sodrel’s article is based on CGIRB’s transition to a fully paperless company, a process that started in mind-2008 when CGRIB teamed with Sitrof Technologies to install the Xerox DocuShare software and the <a title="DocuShare Compliance Module" href="http://sitrof.com/products/docushare-compliance-module/">Sitrof Compliance Module</a> for DocuShare. DocuShare was first configured to mange CGRIB’s non-regulated documents, such as vacation requests, business development information, training information, PowerPoint presentations, spread sheets, status reports, RFI’s and contracts. After giving the staff time to become familiar with DocuShare, Sitrof installed its compliance module a year later. These systems help to automate the workflow and decision process and improve efficiencies and customer service.</p>
<p>CGRIB was able to transform from a heavily paper-centered company into a completely digital, paperless organization in less than two years. Going paperless enabled CGIRB to become more efficient in all areas, with the added bonus of becoming more environmentally friendly. Sodrel encourages paperless transitions in order to help an IRB quickly collaborate, share documents, and review protocols.</p>
<p><a href="http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/IT+Articles/Innovation-in-Ethical-Review/ArticleStandard/Article/detail/719558?contextCategoryId=43496" target="_blank">Click here</a> to read the full article.</p>
<p>&nbsp;</p>
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		<title>Sitrof Technologies Introduces Approve-PTS at DIA Electronic Document Management</title>
		<link>http://sitrof.com/resources/news/sitrof-technologies-introduces-approve-pts-at-dia-electronic-document-management/</link>
		<comments>http://sitrof.com/resources/news/sitrof-technologies-introduces-approve-pts-at-dia-electronic-document-management/#comments</comments>
		<pubDate>Mon, 14 Feb 2011 08:00:49 +0000</pubDate>
		<dc:creator>Sitrof</dc:creator>
				<category><![CDATA[News]]></category>
		<category><![CDATA[21 CFR Part 11]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[linkedin]]></category>
		<category><![CDATA[Microsoft SharePoint]]></category>
		<category><![CDATA[Promotional Tracking System]]></category>
		<category><![CDATA[SharePoint]]></category>
		<category><![CDATA[SharePoint 2010]]></category>

		<guid isPermaLink="false">http://sitrof.com/?p=2514</guid>
		<description><![CDATA[Sitrof Technologies is proud to introduce Approve-PTS Promotional Material Tracking System at The Drug Information Association Electronic Document Management 2011 (DIA EDM). Please come visit Sitrof at DIA EDM in booth #205 to see how Approve-PTS can work for you. Approve-PTS, built on Microsoft SharePoint 2010, connects outside creative agencies, marketing teams and regulatory reviewer--allowing [...]]]></description>
			<content:encoded><![CDATA[<p>Sitrof Technologies is proud to introduce Approve-PTS Promotional Material Tracking System at The Drug Information Association Electronic Document Management 2011 (DIA EDM).</p>
<blockquote><p>Please come visit Sitrof at DIA EDM in booth #205 to see how Approve-PTS can work for you.</p>
</blockquote>
<p>Approve-PTS, built on Microsoft SharePoint 2010, connects outside creative agencies, marketing teams and regulatory reviewer--allowing marketing materials to get reviewed, approved and published in the most efficient manner possible. Jobs are routed via built-in workflows with annotations and version control to retain full audit trail.</p>
<p>“We developed Approve-PTS for a pharmaceutical company to reduce the time needed to circulate, review and approve promotional materials and maintain compliance,” says Bryan Reynolds, co-founder and managing partner of Sitrof. “There is a tremendous need for this product and building it on SharePoint 2010 has been key to quickly launching solutions in a timely fashion.”</p>
<p>Approve-PTS reduces previously untrackable delays and logjams. Reviewers are notified via email that a job is waiting their review. Digital signatures with automatic date and time stamp ensure 21 CFR Part 11 compliance.  In addition, advanced reporting tools allow marketing communication specialists and administrators to collect thorough metrics to resolve delays and improve the process.</p>
<p><strong>About Sitrof</strong></p>
<p>Sitrof provides premier consulting and technology solutions enabling organizations to improve efficiencies and mitigate risk. Backed by decades of industry knowledge and world-class industry partnerships, Sitrof has saved millions of dollars and countless months of time, for hundreds of companies. For more information about Sitrof or Approve-PTS please visit http://sitrof.com</p>
<p><strong>About DIA EDM</strong></p>
<p>For 23 years, DIA EDM Conference has served as a forum for the discussion of emerging standards and the processes for the creation, submission and retention of regulatory information.  This year’s show will focus on The Intersection of Data, Documents and Submissions.</p>
<p><strong>Media Contact:</strong><br />
Gwen Hoover<br />
<a href="http://www.altitudemarketing.com" target="_blank">Altitude Marketing</a><br />
<a href="mailto:gwen@altitudemarketing.com">gwen@altitudemarketing.com</a></p>
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		<title>Sitrof Technologies a Finalist for AIIM Best Practices Award</title>
		<link>http://sitrof.com/resources/news/sitrof-technologies-a-finalist-for-aiim-best-practices-award/</link>
		<comments>http://sitrof.com/resources/news/sitrof-technologies-a-finalist-for-aiim-best-practices-award/#comments</comments>
		<pubDate>Wed, 09 Feb 2011 21:00:22 +0000</pubDate>
		<dc:creator>Sitrof</dc:creator>
				<category><![CDATA[Awards and Speaking]]></category>
		<category><![CDATA[News]]></category>
		<category><![CDATA[21 CFR Part 11]]></category>
		<category><![CDATA[Best Practices]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[Document Management]]></category>
		<category><![CDATA[ECM]]></category>
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		<category><![CDATA[paperless office]]></category>
		<category><![CDATA[Xerox DocuShare]]></category>

		<guid isPermaLink="false">http://sitrof.com/?p=2511</guid>
		<description><![CDATA[Recognized for paperless transformation Sitrof Technologies is pleased announced the end customer, Copernicus Group IRB (CGIRB) was named a finalist for the 2011 AIIM Best Practices Award. The Carl E. Nelson Best Practices Award was established to recognize excellence in information management. Sitrof Technologies implementation of Xerox Corporation’s DocuShare® enterprise content management (ECM) was recognized [...]]]></description>
			<content:encoded><![CDATA[<h4>Recognized for paperless transformation</h4>
<h3>Sitrof Technologies is pleased announced the end customer, <a href="http://www.cgirb.com" target="_blank">Copernicus Group IRB (CGIRB)</a> was named a finalist for the 2011 AIIM Best Practices Award. The Carl E. Nelson Best Practices Award was established to recognize excellence in information management.</h3>
<p>Sitrof Technologies implementation of Xerox Corporation’s DocuShare® enterprise content management (ECM) was recognized as a finalist in the Small Company category for their work in transforming Copernicus Group IRB into a paperless company. CGIRB is now 96% paperless after the 2 year implementation. The paperless endeavor involved a massive legacy document scanning operation, including 1.5 million legacy documents totaling 5 million pages, as well as all internal documents and all inbound paper and electronic documents.  Utilizing the Sitrof Compliance Module for DocuShare, CGIRB is able to maintaining FDA 21 CFR Part 11 compliance.</p>
<p>“We are excited to be a finalist,” said Bryan Reynolds, Managing Partner of Sitrof Technologies. “This was a huge undertaking requiring a lot of time and resources.  The success of the project was due in a great part to the multi-phase plan developed by CGIRB’s director of IT, Jennifer Sodrel.  Internal change management can sometimes be the most difficult part of a paperless implementation and Jennifer nailed it.”</p>
<p>"The quality of the submissions for the Carl E. Nelson Best Practice Award continues to improve raising the bar on best practices while emphasizing innovation, benefits and lessons learned," said John Mancini, President, AIIM. "Our AIIM Emerging Technology Advisory Group (EmTAG) selected the finalists in each category for the Best Practices Award. Our professional members are determining the winner in each category. Each of the finalists share many valuable lessons learned to help others with their implementations.”</p>
<p>AIIM professional members will chose the winner from the finalists. Award winners will be announced at the AIIM Annual Awards Celebration, March 22 at The W Washington, DC, where John Mancini, AIIM’s President, will announce the winner.</p>
<p><strong>About Sitrof Technologies</strong></p>
<p>Founded in 1999, Sitrof Technologies provides a new breed of information management, data protection and compliance solutions.  Sitrof Technologies has earned trusted advisor status with an expanding repeat customer base of over 200 leading enterprise and emerging mid-market companies. Backed by decades of experience and world-class partnerships, Sitrof saves companies millions of dollars across many industries, improving efficiency and mitigating risk.</p>
<p>To learn more email <a href="http://sales@sitrof.com">sales@sitrof.com</a> or call 866-545-8954.</p>
<p><strong>Media Contact:</strong></p>
<p>Gwen Hoover<br />
<a href="http://www.altitudemarketing.com" target="_blank">Altitude Marketing</a><br />
<a href="mailto:gwen@altitudemarketing.com">gwen@altitudemarketing.com</a></p>
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		<title>Sitrof Technologies to Attend DIA EDM Tradeshow in February</title>
		<link>http://sitrof.com/resources/news/sitrof-technologies-to-attend-dia-edm-tradeshow-in-february/</link>
		<comments>http://sitrof.com/resources/news/sitrof-technologies-to-attend-dia-edm-tradeshow-in-february/#comments</comments>
		<pubDate>Tue, 25 Jan 2011 19:51:51 +0000</pubDate>
		<dc:creator>Sitrof</dc:creator>
				<category><![CDATA[News]]></category>
		<category><![CDATA[21 CFR Part 11]]></category>
		<category><![CDATA[Document Management]]></category>
		<category><![CDATA[linkedin]]></category>
		<category><![CDATA[unstructured data]]></category>

		<guid isPermaLink="false">http://sitrof.com/?p=2484</guid>
		<description><![CDATA[Experts in Unstructured Document Management to Premier New Product Princeton, NJ, January 21, 2011- Sitrof Technologies, a company that provides premier consulting and technology solutions, announced today that they will be attending the DIA Electronic Document Management 2011: The Intersection of Data, Documents and Submissions Conference (DIA EDM). DIA EDM will take place in National [...]]]></description>
			<content:encoded><![CDATA[<h3>Experts in Unstructured Document Management to Premier New Product</h3>
<p>Princeton, NJ, January 21, 2011- Sitrof Technologies, a company that provides premier consulting and technology solutions, announced today that they will be attending the DIA Electronic Document Management 2011: The Intersection of Data, Documents and Submissions Conference (DIA EDM).</p>
<p>DIA EDM will take place in National Harbor, MD from February 15-17, 2011. The Conference has served as a forum for the discussion of emerging standards and the processes for the creation, submission and retention of regulatory information. This year’s program has been enhanced to provide a more comprehensive and interactive experience. The renewed approach affords opportunities to learn about and discuss the benefits and challenges of global standards development and implementation. Please come visit Sitrof at booth #205, as we have some exciting new offerings to make document management and compliance a snap.</p>
<p>"We are excited to have the opportunity to attend this year’s conference," says Bryan Reynolds, managing partner and co-founder of Sitrof Technologies. “Stay tuned for an announcement of a new offering for life sciences to streamline the management of marketing and promotional materials.”</p>
<p>About Sitrof</p>
<p>Founded in 1999, Sitrof Technologies is a privately held profitable company with headquarters in Princeton, NJ, and offices in San Francisco and London. Sitrof Technologies has earned trusted advisor status with an expanding repeat customer base of over 200 leading enterprise and emerging mid-market companies. Backed by decades of experience and world-class partnerships, Sitrof saves companies millions of dollars across many industries, improving efficiency and mitigating risk. To learn more visit http://www.Sitrof.com, email sales@sitrof.com or call 866-545-8954.</p>
<p>About DIA EDM</p>
<p>Over the past 23 years, DIA EDM strives to teach participants to recognize the challenges and complexities of globally managing information, explain the importance of aligning standards, technology and leveraging interoperability, recognize the vital role of metadata in the intelligent management of data, documents and submissions as well as identify trends and standards in electronic records. To learn more about DIA EDM visit http://www.diahome.org/DIAHome/Home.aspx.</p>
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		<title>DIA EDM: Just around the corner</title>
		<link>http://sitrof.com/resources/insights/dia-edm-just-around-the-corner/</link>
		<comments>http://sitrof.com/resources/insights/dia-edm-just-around-the-corner/#comments</comments>
		<pubDate>Wed, 19 Jan 2011 17:46:20 +0000</pubDate>
		<dc:creator>Sitrof</dc:creator>
				<category><![CDATA[Insights]]></category>
		<category><![CDATA[21 CFR Part 11]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[Document Management]]></category>
		<category><![CDATA[ECM]]></category>
		<category><![CDATA[Enterprise Content Management]]></category>
		<category><![CDATA[FirstDoc]]></category>
		<category><![CDATA[FirstPoint]]></category>
		<category><![CDATA[linkedin]]></category>
		<category><![CDATA[Microsoft SharePoint]]></category>
		<category><![CDATA[SharePoint]]></category>
		<category><![CDATA[SharePoint 2010]]></category>

		<guid isPermaLink="false">http://sitrof.com/?p=2463</guid>
		<description><![CDATA[Electronic Document Management 2011: The Intersection of Data, Documents and Submissions Once again the team at Sitrof is looking forward to exhibiting at the DIA EDM show, February 15-16 at the Gaylord National Hotel and Convention Center. Please come visit us at booth #205, as we have some exciting new offerings to make document management [...]]]></description>
			<content:encoded><![CDATA[<p><strong>Electronic Document Management 2011: The Intersection of Data, Documents and Submissions</strong></p>
<p>Once again the team at Sitrof is looking forward to exhibiting at the DIA EDM show, February 15-16 at the Gaylord National Hotel and Convention Center. Please come visit us at booth #205, as we have some exciting new offerings to make document management and compliance a snap.  Our newest product is built  on the industry standard Microsoft SharePoint 2010 for ease of integration into all other collaborative and document management systems. A version is also available for EMC Documentum.  In addition we will continue to support, configure and install life sciences application on both CSC FirstDoc and CSC FirstPoint.</p>
<p>Over the past 23 years, the DIA EDM Conference has served as a forum for the discussion of emerging standards and the processes for the creation, submission and retention of regulatory information. This year’s program has been enhanced to provide a more comprehensive and interactive experience. The renewed approach affords opportunities to learn about and discuss the benefits and challenges of global standards development and implementation. Additionally, the design and development of business processes to facilitate the conversion of data into document components resulting in high quality regulatory submissions will be examined. Managing information in a completely electronic environment and enabling the current and future electronic submission standards landscape are key focuses.</p>
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		<title>Biomedical Research Group Relies on Xerox DocuShare to Store and Share Data; Expects to Save Millions</title>
		<link>http://sitrof.com/industry-trends/biomedical-research-group-relies-on-xerox-docushare-to-store-and-share-data-expects-to-save-millions/</link>
		<comments>http://sitrof.com/industry-trends/biomedical-research-group-relies-on-xerox-docushare-to-store-and-share-data-expects-to-save-millions/#comments</comments>
		<pubDate>Mon, 20 Dec 2010 18:56:06 +0000</pubDate>
		<dc:creator>Sitrof</dc:creator>
				<category><![CDATA[Industry Trends]]></category>
		<category><![CDATA[21 CFR Part 11]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[ECM]]></category>
		<category><![CDATA[Enterprise Content Management]]></category>
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		<category><![CDATA[paperless office]]></category>
		<category><![CDATA[Xerox DocuShare]]></category>

		<guid isPermaLink="false">http://sitrof.com/?p=2393</guid>
		<description><![CDATA[PALO ALTO, Calif. -- The Copernicus Group Independent Review Board (CGIRB) is using Xerox Corporation’s (NYSE: XRX) DocuShare® CPX Enterprise Content Management (ECM) software to share and store critical biomedical research documents for the Food and Drug Administration – and expects to save more than $2 million in doing so. CGIRB uses a secure Web-based [...]]]></description>
			<content:encoded><![CDATA[<p>PALO ALTO, Calif. -- The <a href="http://www.cgirb.com" target="_blank">Copernicus Group Independent Review Board (CGIRB)</a> is using Xerox Corporation’s (NYSE: XRX) DocuShare® CPX Enterprise Content Management  (ECM) software to share and store critical biomedical research documents for the Food and Drug Administration – and expects to save more than $2 million in doing so.</p>
<p>CGIRB  uses a secure Web-based portal with DocuShare to manage large volumes of electronic paper documents related to client studies and compliance audits. The ECM solution has saved CGIRB an estimated $160,000 annually on shipping, supplies and personnel costs, and has reduced the time to process requests from an hour to minutes. Before, CGIRB manually printed and shipped documents to multiple locations for review and filing – a timely and costly process.</p>
<p>“Federal guidelines require CGIRB to retain files up to 10 years, so we needed a solution that would eliminate the drain on our resources. DocuShare software has done that and helped us be more efficient and competitive,” said Jennifer Sodrel, director, Information Management, CGIRB.</p>
<p>The review board gains further efficiency and control by using a <a href="http://sitrof.com/products/docushare-compliance-module/" target="_self">DocuShare Compliance Module</a>, created by Sitrof Technologies, which generates a complete audit trail of edits made to each document, including when and by whom. It also offers e-signature capabilities that comply with pharmaceutical industry regulation FDA 21 CFR Part 11, and eliminates the need for written signatures.</p>
<p>“Paper-intensive organizations such as CGIRB are taking control of their documents, rather than feeling overwhelmed by them,” said David Smith, vice president, DocuShare Business Unit, Xerox Corporation. “With DocuShare, CGIRB has transformed its workplace – allowing them to concentrate on their core business while slashing costs, decreasing turnaround times and improving data accuracy.”</p>
<p><a href="http://news.xerox.com/pr/xerox/electronic.aspx?fid=122466&amp;id=E0C26839" target="_blank">Click here to see CGIRB video case study.</a></p>
<p><a href="http://sitrof.com/resources/copernicus-group-irb-case-study/" target="_self">Click here to read full case study.</a></p>
<p><strong>About Xerox DocuShare</strong></p>
<p>Xerox DocuShare is an enterprise content management platform developed by Xerox Corporation. DocuShare’s capabilities range from basic content services to more robust business process automation and paper-to-digital solutions. It offers a number of partner solutions for vertical and cross-industry business processes.<a href="http://news.xerox.com/pr/xerox/biomedical-research-group-relies-on-Xerox-DocuShare.aspx?link_page_rss=188977" target="_blank"> See full release at Xerox Newsroom.</a></p>
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		<title>FirstDoc Migration – A Different Approach</title>
		<link>http://sitrof.com/resources/case-studies/firstdoc-migration-%e2%80%93-a-different-approach/</link>
		<comments>http://sitrof.com/resources/case-studies/firstdoc-migration-%e2%80%93-a-different-approach/#comments</comments>
		<pubDate>Fri, 05 Nov 2010 16:59:34 +0000</pubDate>
		<dc:creator>Sitrof</dc:creator>
				<category><![CDATA[Case Studies]]></category>
		<category><![CDATA[21 CFR Part 11]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[Content migration]]></category>
		<category><![CDATA[Document Management]]></category>
		<category><![CDATA[Documentum]]></category>
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		<category><![CDATA[FirstDoc]]></category>
		<category><![CDATA[linkedin]]></category>

		<guid isPermaLink="false">http://sitrof.com/?p=2144</guid>
		<description><![CDATA[Technical Paper Background A large generic pharmaceutical manufacturer needed to migrate a subset of documents from their legacy GxPharma solution to a FirstDoc FDQM 5.0 system. Sitrof is a vendor neutral integrator, always looking for the best approach for individual customers.  We also believe in building on past successes. After much research and consideration with [...]]]></description>
			<content:encoded><![CDATA[<h2><strong>Technical Paper</strong></h2>
<h3><strong>Background</strong></h3>
<p>A large generic pharmaceutical manufacturer needed to migrate a subset of documents from their legacy GxPharma solution to a FirstDoc FDQM 5.0 system. Sitrof is a vendor neutral integrator, always looking for the best approach for individual customers.  We also believe in building on past successes.</p>
<p>After much research and consideration with a previous customer (<a href="http://sitrof.com/resources/insights/case-study-of-a-firstdoc-and-documentum-migration">See previous case study</a>), we decided to build a custom migration utility rather than use an off the shelf product like <a href="https://gallery.emc.com/docs/DOC-1039">Buldoser</a><strong> </strong> or <a href="http://www.migration-center.de/Migration-Center.568.0.html">FME’s migration-center</a>.  That approach proved to be successful and we had envisioned using this custom utility for future migrations.</p>
<p>This particular client preferred to use CSC Configuration Management Utility (CMU) to perform the migration.  They had confidence in CMU and had performed a similar migration several years ago.  They were looking to adopt a consistent migration approach and toolkit to perform the FDQM migration along with any other migrations needed in the future.  While Sitrof had experience using the CMU to move FirstDoc configurations from environment to environment, we had never used the tool to perform a migration to or from a repository outside of FirstDoc.</p>
<p>The FirstDoc solution was already in production, presenting an interesting set of circumstances.  Other complicating factors were the GxPharma system was running Documentum version 4.2.8 while the FDQM system was running Documentum version 6.0 SP1 as illustrated below.</p>
<p><img class="aligncenter size-full wp-image-2152" title="First Doc Migration" src="http://sitrof.com/wp-content/uploads/2010/11/First-Doc-Migration-Image.jpg" alt="First Doc Migration" width="256" height="74" /></p>
<h3><strong>The Sitrof Approach</strong></h3>
<p>We had hoped to use CMU 5.0 to perform the entire migration.  However, CMU 5.0, which uses DFC 6.0 SP1, cannot connect to a 4.2.8 repository.   We worked around this issue by using CMU 4.2 to perform the export while using CMU 5.0 to perform the import and any post import processing steps.</p>
<p>A typical E-T-L (extract, transport, load) model for this type of migration would be to export the content, apply metadata transformation rules and then import into the FirstDoc repository.  With past migrations, we exported the metadata into database tables which provides an efficient and convenient way to update metadata values based on migration rules (e.g. existing documents with r_object_type of sop will have a document_type value of Standard Operating Procedure).</p>
<p>CMU does not provide a way to write metadata to a database but instead, writes it to an XML file.  Fortunately, rather than having to modify values within the XML export file, the CMU provides a means to transform values during the export itself so that the metadata in the resultant XML already has the transformed value.  Using the ‘transform’ attribute in the CMU ObjectExporter allows you to call your own JavaScript code where more advanced transformation rules can be applied.  Many of our transformation rules were handled in JavaScript code where either the rule was hard coded or read in from spreadsheets that contained the mapping rules.</p>
<p>Once the export was complete, the exported metadata resided in XML and the content resided on a file system.  The import process was very straightforward; we just used the CMU ObjectImporter to import the exported XML files.  The ObjectImporter provided a handy “save_object_id_map” feature that produced a CSV file that created a map of the old r_object_id to the new r_object_id.  This map can be useful if you wish to import audit trail values but need to update the old object Id to the new object Id.</p>
<p>Once the documents were imported, there were several post import steps that had to be performed.  These tasks included creating FirstDoc relationships between documents (e.g. an SOP related to a Form), calling the FirstDoc methods AutoNumber (to assign a new document number), SetACL (to apply the appropriate document security based on the document’s type and subtype) and SetLinks (to link the document to the correct folder location).  The CMU TaskManager was used to call a series of JavaScript programs to perform these tasks.</p>
<h3><strong>Observations</strong></h3>
<p>We were pleasantly surprised by the number of CMU options available to facilitate a migration.  For this particular migration, 40,000 documents (all versions) and tens of thousands of audit trail records were migrated.  While the performance was adequate for a migration of this size, the CMU would not be our tool of choice for a larger scale migration.  Also, the CMU would not be a viable option if there was a need to migrate from a non-Documentum based source system.  Nonetheless, since most FirstDoc customers already own the CMU it should be considered as an option for your next migration.</p>
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