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.

 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

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.

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

Challenges with Common Document Sharing Methods

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.

Email

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.

Fax

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.

FTP

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.

Third-Party Solutions

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.

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.

Peer-to-Peer Data Sharing: The Ideal Solution

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.

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.

Lower Cost, Improved Performance

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.

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.

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.

Improved Security

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.

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.

Accurate Version Control and Tracking

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.

Cost-Effective Infrastructure

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.

Integration with Existing Document Management Systems

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.

Universal Platform Support

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.

Conclusion

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.

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.

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.

1 J. Malek, Transforming Life Sciences: The Connected Life Sciences Company,

Cisco Internet Business Solutions Group (IBSG), July 2009

2 Peer-to-Peer, Harnessing the Power of Disruptive Technologies, March 2001

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

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 Sitrof Compliance Module 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.

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.

Click here to read the full article.

Copernicus Group IRB is a paperless office whose shift from being paper-based was led by Sitrof Technologies in a large, three-phase project. This has saved the organization more than $2 million on shipping, printing, postage, and file storage. Sitrof’s installation has translated to CGIRB becoming 98% paperless.

CGIRB was honored by InfoWorld for being one of the most innovative IT initiatives that fall under the umbrella of sustainability. The award honors companies who have embraced green technology to drive projects and develop products aimed at boosting energy efficiency, trimming waste, and reducing or eliminating the use or the production of harmful substances are selected for the Green 15.

CGIRB staff can now digitally search through 5 million pages' worth of legacy documents and process client submissions into the electronic workflow in an average of 3.7 minutes, as compared to 104 minutes in its paper-based era. Less time, money and effort are spent on everyday tasks, making CGIRB more efficient and green, thanks to the Sitrof installation.

To learn more about the InfoWorld Green 15 and read the complete list of winners, please click here.
To read the full case study on Sitrof and CGIRB, please click here.

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.

The Challenge

Most petitions or submissions received by the Agency arrive through regular mail and are manually routed to various departments. The balance of submissions are received as attachments to email. This creates a number of inefficiencies such as duplication of documents, the inability to know where various submissions are within the process, as well as the inability to provide feedback to petitioners on the status of the submission. The Agency was searching for an electronic document management system, to alleviate the identified issues within the current paper process and increase the efficiency of the state agency. It was imperative that the electronic process closely mimic the one currently followed.

The Solution

The Agency hired Sitrof Technologies of Princeton, NJ to design and implement a document management system and workflows based on Microsoft SharePoint 2010. First the team developed a process requiring all submissions, regardless of their origin and how they were received, be converted into electronic form and then sent to SharePoint for tracking and storage. The format of the document, physical or electronic, dictates the next step in the process. If the document received is in paper form it must be scanned into PDF format, utilizing the existing Xerox multifunction devices with are Extensible Interface Platform (EIP) enabled to streamline and customize the process.

If the document received is already in electronic format it will be uploaded directly to SharePoint to a specific folder related to the submission for further processing.

The ScanFlowStore converts the scanned paper document to a text searchable PDF and place it on the file system. ScanFlowStore is utilized to break apart batches of submissions so that the mail room can scan multiple documents at the same time enabling them to improve efficiency.

The Sitrof Ingester takes the output from ScanFlowStore and routes to SharePoint 2010. Knowledge workers in the mail room use an indexing screen to define the type of submission which then automatically distributes the submission to the appropriate division(s) within the Agency. Once the document has been indexed, a set of validations execute to ensure that the data the user entered matches the rules set in the system for submission properties and starts the appropriate actions. Newly indexed documents are automatically routed to the appropriate folder within SharePoint 2010.

For example, if supporting documentation is required before a submission can be approved, the workflow will enter a paused state until additional support documentation is received. Once a supporting document is received, the workflow will continue allowing the knowledge worker to determine if the additional documentation is sufficient to continue the process or if more documentation is required.

Two submission workflows were created in SharePoint 2010 for the business process related to non-delegated and delegated submissions.

Delegated Submission

After a delegated submission is assigned by the department admin and email is automatically generated to the assigned knowledge worker notifying them of a task within SharePoint. Once within SharePoint they have access to all the available information about the submission from a single screen as well as the original submission and any supporting documentation which is related to the specific submission. The knowledge worker has an option to Approve, Reject, Request Information or escalate as a Non Delegated Authority Process. The knowledge worker would also have an option to reassign the task.

Non-Delegated Submissions

Non-delegated Authority Submissions are submissions that require a public hearing. These submissions go to a number of distribution groups and require a number of different reviews before a decision is made by the Commissioners at the Public Hearing. The specific groups which receive the submission are dictated by the type of submission received. All of the different groups review and provide various comments on the submission. General Counsel can annotate the submission. After all knowledge worker reviews are completed, General Counsel prepares an opinion document that takes the reviews into consideration and is used by the Commissioners for the public hearing. General Counsel may also redact portions of content related to the submission.

Similar to the delegated workflow, the non-delegated submission is indexed by the mailroom clerk and then distributed to the relevant department administrators in the respective divisions that will review the submission. The department admin would then assign reviewers who would have the ability to comment on the submission. Apart from assigning reviewers, the admin would also click on the hyperlink to open the submission in Adobe Acrobat and invite reviewers to gather the comment.

Shared Review, Comments and Tracking Submissions

The department admin enters the email address of all the reviewers who are to participate in the workflow, automatically generating an email notification inviting them to review the submission. The reviewers then comment on the submission, which are all tracked in the system. Pre-determined due dates are set for tasks automatically generating a reminder email to the reviewers.

Once all the reviewers complete their tasks, a new task is created for a pre-assigned user to prepare the memo/opinion for the submission. This user views all the review comments and has to write up an opinion based on the comments. After the memo is prepared, the clerk is then notified to update the action date on the submission. This action date is the actual date of public hearing.

Following the public hearing, the clerk updates the status of the submission depending on the decision made by the commissioners. The clerk also uploads any documents from the public hearing to the ‘Submissions Drop Box’ with the appropriate index values related to the submission.

The Results

As common with every state in the Union, budget cuts have necessitated deep personnel cuts. The old adage ‘Do more with less’ is actually true with the Sitrof/SharePoint solution.

• Reduced Paper: Routing and reviewing petitions electronically to multiple people greatly reduced the need to print duplicate copies which also reduced the printer costs.
• Improved Productivity: Entire staff ranging from Clerks to General Counsel spent far less time in document routing, petition reviewing and searching, and scheduling Public Hearings.
• Petition Tracking: SharePoint Workflow reports and logs meant every petition filed could be tracked at a granular level which was very important due to the time sensitive nature of the petitions.
• Improved Compliance: All petitions are now processed within the time deadlines specified by the legislation.

Next Steps

The State has several initiatives to implement SharePoint 2010 document management and collaboration workflows in various departments and divisions across the State.

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

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 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.

"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.”

About Sitrof

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.

About DIA EDM

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.

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.

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.