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.

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.

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.

The Sitrof Approach

Backed by years of life sciences experience and world-class software industry partnerships, Sitrof is the industry leader in vendor-neutral system integration services.

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.

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.

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.

The Sitrof Process

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 offer an upfront fixed price.

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.

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.

Don’t go it alone

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.

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.

Dan Wheeler is a managing partner and co-founder of Sitrof Technologies, 700 Alexander Park, Princeton, N.J. 08540.

• By a financial institution to communicate with or service the financial institution's customers
• By the financial institution's employees in their personal or professional capacities
• By the financial institution's employees or contractors outside the office

The guidance thus addresses sector-specific regulatory requirements, such as Gramm-Leach-Bliley Act compliance and FINRA rules applicable to securities firms.  It also addresses concerns that are relevant to financial institutions as employers, such as bank employees' personal use of social media.

The BITS report is particularly significant because it responds to a need for guidance in an industry that is increasingly using social media, but still lacks clear rules from regulators regarding such activities.  While FINRA has issued guidance on use of social media by firms subject to FINRA's oversight, the federal banking agencies have not , to date, issued detailed guidance to the banking industry on banking compliance issues raised by use of social media.  

Also, while targeted at the financial services sector, the report also has relevance to many other types of users of social media.  It gives guidance, for instance, on coordinating a company's social media policies with its other policies, and performing a risk assessment to determine the risks a company's social media activities could pose.

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 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.

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.

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 Vault solution 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

The panel will discuss topics around capture, store, share and control within ECM, focusing on going paperless. Attendees will be provided with recommendations, best practices and challenges that businesses and organizations face when trying to move to a paperless environment.

"Sitrof has led a number of paperless initiatives in highly regulated industries," said Reynolds. "I’m looking forward to speaking about the numerous benefits of going paperless, as well as the challenges involved."

The AIIM Garden State Chapter panel event will be on Tuesday, May 10 at the Woodbridge Hilton in Iselin, NJ. The event starts with a networking session at 5:30pm. Click here to learn more or to register.

About Sitrof
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 email sales@sitrof.com.

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 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.

“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.”

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.

About Sitrof

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

About DIA EDM

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.

Media Contact:
Gwen Hoover
Altitude Marketing
gwen@altitudemarketing.com

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 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.

“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.”

"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.”

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.

About Sitrof Technologies

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.

To learn more email sales@sitrof.com or call 866-545-8954.

Media Contact:

Gwen Hoover
Altitude Marketing
gwen@altitudemarketing.com

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.

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.

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.

“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.

The review board gains further efficiency and control by using a DocuShare Compliance Module, 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.

“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.”

Click here to see CGIRB video case study.

Click here to read full case study.

About Xerox DocuShare

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. See full release at Xerox Newsroom.

A major pharmaceutical company, and long standing Sitrof client, used a very highly customized Documentum WDK Application for content authoring and submission management. While this system served the company well for many years, it ran counter to the company’s IT philosophy of moving to commercial off-the- shelf solutions.

Computer Science Corporation (CSC) was contracted to gather application requirements, perform production configuration and installation. Sitrof was engaged to gather the extensive document, user, configuration and customization migration requirements as well as to perform the design and execution.

This case study discusses the unique challenges such a migration and upgrade effort presents, including:

• Key factors influencing the migration approach ( rolling  vs. an in-place “all-at-once” migration)
• Porting customizations from the legacy system to the upgraded system
• Ensuring external systems that interfaced with the legacy system continued to work with the new system

Migration Approaches

Two Migration Approaches were considered and reviewed for the migration effort:

Rolling Migration

A rolling migration is broken up over time to facilitate a gradual, incremental migration. The migration is divided into distinct chunks using business specific criteria. Documents are migrated from the legacy system on a department- or product-level basis to the new system.

For such an approach, the configurations and customizations to support the entire migration effort over its entire timeline are installed in the new system before any actual content is migrated. This ensures that all the functionality is always available as soon as the content is.

The following diagram illustrates such an effort:

Often the different departments slated to use the new system convert their business processes at non-coinciding times in support of the migration. If this had been a limiting factor, then a rolling migration approach would be the only possible approach. However, this was not the case in this project, which allowed us to explore following migration approach.

In-Place “All-At-Once” Migration

An “all-at-once” migration is where all the documents, users, configurations and customizations necessary for a complete migration are done in a single chunk, usually over an extended weekend.

An in-place upgrade is one where an upgrade to the existing software is done instead of migration to a new system with the new software. An advantage of this approach from a Documentum perspective is that the unique object identifiers are left intact whereas a rolling migration requires that the object identifiers change. This was the main driving factor for the selection of this migration approach, because the business used a submission publishing system that stored these identifiers. Updating the object identifiers in the publishing system would have added increased project complexity and extended project timelines.

The following high-level process was followed in order to move the legacy system to a new FirstDoc Research & Development (FDRD) environment:

1.      Clone the existing docbase (database + content) to new target hardware and perform an in-place Documentum upgrade

2.      Install FDRD into the upgraded docbase

3.      Convert all documents to FirstDoc aware objects (i.e. change the documents’ object types to the FirstDoc specific object types)

4.      Call the FirstDoc SetACL and SetLink routines to ensure that the documents’ permissions and folder locations are set to business requirements

These steps are illustrated in more detail below:

Configurations & Customizations

Because migration involved moving from a legacy Documentum System to a FirstDoc FDRD system, it was necessary to convert all documents to FirstDoc objects.  Sitrof interacted closely with the client Subject Matter Experts (SMEs) to determine the FirstDoc type/subtype/units for all the existing documents. In cases where documents could not map to existing document inventory, Sitrof worked with CSC in order to have new types/subtypes/units added to the system.

The client also had WDK Customizations in the legacy systems, which Sitrof helped port over to the FDRD system by merging this functionality into the FDRD UI where possible.

Secure Login

The client’s IT security policy dictated that all passwords traveling on their networks be encrypted. However, using network sniffers, it was found that passwords were being passed from the WebTop/FirstDoc login screen in the application server to the Content Server in clear text.  Sitrof customized the WebTop/FirstDoc login component to encrypt the passwords passed to the Content Server.

Remote Import

A customization of the legacy system was the ability to import documents from a list of pre-defined FTP servers directly into the Documentum repository. Sitrof merged this functionality into the FirstDoc Bulk Import function so that document import from FTP Servers is treated in an identical manner to the documents imported from the File System.

Product Dictionary Loader

The client had an existing data warehouse that contained product, regulatory, clinical and nonclinical information, and did not want to manually maintain these dictionaries within FDRD.  Sitrof developed a series of custom jobs that queried the data warehouse on a daily basis and automatically created the appropriate FirstDoc Product dictionaries within FDRD whenever new data appeared in the data warehouse.

Architecture Sizing / Performance Testing

Because this was a mission-critical system, the client wanted to ensure that it was properly sized to handle current and future volume.  Sitrof worked with the client’s internal testing and infrastructure teams to develop performance tests to stress all individual components of the system. The joint team also stress-tested the overall system itself by designing “day in the life” scripts.

External Systems

Special attention was paid to all external systems that interfaced with the legacy system to ensure that the interfaces would work after migration. If a modification to the interface was needed, Sitrof made this change.

Trackwise Integration

The existing legacy system was integrated with Trackwise, allowing users to view content residing in Documentum from a Trackwise screen.  Sitrof ported this customization to work with the latest version of Documentum and FirstDoc.  Sitrof also customized FirstDoc to write the unique Documentum identifier to Trackwise any time a health authority correspondence document was approved within FirstDoc.

Conclusion

Sitrof was involved from inception to the finish of the project, and oversaw a large part of the development and migration efforts that were required for a successful completion of the project. The client was able to decommission their legacy solution shortly after going live with the FDRD solution.

Together they transformed CGIRB from an entirely paper-reliant company with millions of pages of legacy documentation into a completely digital paperless organization. CGIRB chose Sitrof to handle this project because of Sitrof's specialty in unstructured data management and extensive experience in FDA 21 CFR Part 11 compliance. Sitrof installed Xerox DocuShare and the Sitrof Compliance Module to automate the workflow and decision process; to improve efficiencies and customer service; all while remaining compliant. The benefits of going paperless have been numerous for CGIRB and the clinical trial sponsors they work with on a daily basis. Most notably, the solution, which ties into CGIRB’s proprietary Protocol Tracking System (PTS) has sped up their review process and given clients real time access to status and documentation through an enhanced web portal, Connexus. The article, which notes CGIRB's large donation of paperclips to local schools, also touches on CGIRB's evolution as a greener, more efficient company.

"Taming the Beast," is in the November-December 2010 issue of Bio IT World and can be read online here.

The full Copernicus Group IRB Case Study can be read here.