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

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.

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

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.

With deep domain expertise, CSC designed FirstDoc and FirstPoint to meet global regulatory compliance requirements and to improve an organization’s overall business productivity. FirstDoc is based on Documentum and is also available with a full featured SharePoint user experience (SPX) and can extend the use of FirstDoc to secure collaboration portals. FirstDoc SPX enables familiar user interfaces of SharePoint and Microsoft Office tools to enable controlled, real-time co-authoring and edit capabilities while maintaining the rich functionality and security of Documentum.

FirstPoint utilizes the built-in functionality in SharePoint, adds those features necessary for highly regulated environments, and fully complies with the FDA’s 21 CFR Part 11 requirements including audit trail, electronic signature and enhanced security.

Sitrof Technologies has many years of experience providing solutions built on the FirstDoc platform. Custom integrations into legacy systems, training and support are a few of the additional services Sitrof has provided to many top 20 pharmaceutical companies.

"We are proud to have received certified status with CSC," said Bryan Reynolds, Managing Partner, Sitrof Technologies. "With years of experience with FirstDoc in the life sciences market we are anxious to begin implementing FirstPoint solutions as well as continuing our expansion of robust content management solutions into other regulated industries."

About Sitrof Technologies

Sitrof Technologies is a document and records management consulting company that provides the technology to enable companies to create, manage, deliver and archive documents and records across their organizations. Known for their expertise in unstructured data for information management, data protection and compliance, Sitrof brings together people, processes and documents to help clients prosper. Backed by decades of experience and world-class partnerships, Sitrof saves companies millions of dollars across many industries, improving efficiency and mitigating risk.

About CSC

CSC's Global Healthcare Group, which serves healthcare providers, health plans, pharmaceutical and medical device manufacturers, and allied industries around the world, is a global leader in transforming the healthcare industry through the effective use of information to improve healthcare outcomes, decision-making and operating efficiency. For more information, visit http://www.csc.com/ecmc

Yesterday I sat on a panel discussion in New York.  I sat between 2 different open source ECM vendors, Alfresco and Nuxeo in front of over 70 members of the ARMA and AIIM's New York Metro chapters.  Being the consultant on the panel,  I felt I was in a unique position to cut through some of the hype regarding the two different "infomercials" we have become accustom to in these types of settings with vendors.

As I listen to the stories go back an forth about how open source is good and closed source is bad, I cant help but wonder;  am I moving from one "locked-in" situation to another if I implement open source.   I realize the open source vendors say that if I am not happy with the direction of the software I can take the source and own it.  Lets be realistic here, there are very few, if any, companies that will take the million plus lines of source code and know what to do with it.  That being the case I think it is very important to go into your choice with your eyes wide open.

While Sitrof does work with Alfresco and has a strong working knowledge of the platform we also work very closely with many different traditional software vendors like Microsoft and EMC.  I feel if I were to walk away from this meeting with a clear point of view it would be - regardless whether you are interesting in traditional software like Microsoft SharePoint or if you want to embrace the world of open source like Alfresco and Nuxeo - you must first have a very clear understanding regarding your end user requirements.  Requirements will determine if open source or traditional software is right for you.

As part of the panel the questions were handed out ahead of time.  I wanted to spend a some time sharing my answers.

Defining Open Source ECM

What is Open Source ECM and what is it not?

• The term “open source” refers primarily to a type of outbound licensing paradigm, but also to a method of software development. To understand it you need to focus on the word “Source”. This refers to the code that developers write. In the case of Windows this source is closed and not accessible to the public to work on. In the case of “Open Source” the source code is open and available for edit by anyone who has access and ability. As this relates to Enterprise Content Management there is no difference. The “open source” code related an ECM project is rich with features and functions that help organizations work with business processes related to unstructured data. The key is the code associated is available for enhancement and modification to the general public / community member.

How did it begin?

• It’s beginnings are not new. Many people would say it is as old as the software industry. Basically back in the 70’s AT&T was under a lot of heat for being monopolistic. They developed a new operating system call UNIX (Uniplexed Information and Computing System – allegedly a pun on the work “eunuchs”). In my opinion, that was the true beginning however, I think the biggest growth came when Linux came on the scene. A new operating system that allowed for alternatives to proprietary software and could be used on the rapidly growing Intel chip.

What is the premise?

• Free redistribution
• Source code available
• Derivative works permitted
• Integrity of author’s source
• No discrimination against persons or groups
• No discrimination against fields of endeavor
• Distribution of license with derivative works
• License must not be specific to a product
• License must not restrict use of other software
• No provision of license may be predicted on any individual technology or style of interface.

Is it freeware?

• In some cases it is freeware however, licensing is much more complex than just calling it freeware. Free really refers to the freedom of use rather than to price. There are no restrictions on putting a price on the distribution of the software however; it is usually prohibited to place restrictions on exercise of a sub-license agreement. Thus in practical terms, it is impossible to charge license fees for free software. However, it is possible to charge for maintenance, customization and other services.

How is Open Source ECM licensed?

• Typically these are direct licensing models. In other words, a licensee that accepts software under the terms of the GPL and distributes it to another does not sub-license the rights in the software. Most open sources licenses are direct grants from the author to anyone that wishes to take the software under license. There are a lot of different licenses out there and you can locate most of them with a simple web search. Mozilla Public License, Apache and GNU General Public License (GPL) are a few.  Alfresco is the only software we work with under the open source ECM vendor space and it uses the Mozilla Public License v. 1.1 with an attribution clause added.

What are the component parts of Open Source, E.g.: RIM, Imaging, DAM, etc.

• Access & User Functions - Check in, Check out, Versioning, Ranching, DRM,DAM, Search, Subscriptions, Renditions, etc.
• Analysis - Categories, Document structures, metadata management, language translation, etc.
• Collaboration - Calendar, document sharing, threaded discussions, etc.
• Administration - Management, reporting, etc.
• Security - ACL, User authentication, End user management, etc.
• Records Management - Classification, Automation, Hold, File Plan management, etc.
• Storage - Hierarchical storage, Database, Native document storage, etc.
• Web Publishing - Content management, portal management, etc.
• Workflow Processing Management - Workflow management, Graphical tools, APIs, etc.

Comparing Open Source ECM to established ECM suites

What are the costs and how are costs compared?

• Established ECM suites usually charge by the user/server/both with annual maintenance tack on to cover issues, bugs, new releases. In the open source model you typically get the community editions of the software at no cost. These are only supported by the community though forums and a reasonable knowledge base depending on the following of the product. If you are looking for enterprise level support it can be purchased. In most cases they will charge a fee per user or per sever CPU. Depending on the size of the system there does come a point where established ECM can cost equal to or even less than open source.

How can we categorically analyze capabilities?

• Yes, this can be done. We typically use a spreadsheet that list of over 200 features that should exist in the perfect ECM solution. We work with our customers when they are making a decision to move forward with a solution to compare and contrast the different tools against our spreadsheet. In addition the feature comparison we also map out detailed end user requirements and weight the appropriate features. This allows us to categorically chose the appropriate solution.

What is the development effort required to implement?

• This ties back to the detailed user requirements and the delta between the chosen solutions out-of-the-box features vs. customizations required to fully meet the requirements. In some cases the effort is minimal. In other cases the effort is very costly. One of the things we do is to determine the hard ROI that can be obtained when deploying and ECM solution. This can be used to determine whether the project will be profitable or not. This is true if the project is traditional ECM or an open source ECM.

What technical level of expertise is required to implement?

• Depends on the user requirements in order to determine the level of development required. Typically on a medium sized project you need a project manager, business analyst and technical lead. In more complex projects you need multiple resources.  For the most part you do not need any special resources for either open or closed software.  They should be interchangeable.

Organizations expect 80% out of the box capabilities. Is this met?

• Again, this depends on the user requirements.  There are a lot of different features and functions available is open and closed source ECM solutions.  In order to determine if you can get 80% usage out-of-the-box you must do due diligence by mapping your requirements to the features and functions and determining the delta between the two.

What about support?

• In most cases the companies provide email, and phone support if you are paying for their maintenance plan. You also have access to the knowledge base and FAQs. There are also companies, like Sitrof that offer supplemental support for most of the major ECM products including open source products like Alfresco.

What are the negatives, the red flags? Where would OS not be applicable?

• Depends on the user requirements the level of customization needed to make the software meet your requirements.  If you have to make customizations you run the risk of costly migrations or an inability to upgrade.

Maturity and capabilities aspects of Open Source ECM products

Are current standards adhered to?

• In our experience, most main stream open source solutions follow good open standards.

What is the sweet spot of appropriateness in terms of size of application and aspect of ECM?

• I don’t think there are any limitations in size. Alfresco has numerous enterprise deployments.

Future direction

Where is development headed for these products?

• I would let Alfresco speak to this. I would say they are headed in the same direction that traditional ECM solutions are headed in.

Are there Web 2.0 (Social Networking) capabilities that will be integrated?

• I would let the open source vendors answer this question as well regarding their road map.  For the most part these capabilities are developed by the vendor and associated community.  I would hope that they are headed in this direction because there are a very rich set of features available in social networking built in to SharePoint 2010.

Is there a cultural shift phenomenon that impacts Open Source in general?

• SharePoint

Are there any trends we can look for?

• SharePoint

The fact is that Microsoft and SharePoint have landed and there is no escaping the power and productivity of this amazing product. From the Microsoft Executive Keynotes, partner spotlight sessions and the impressive real-world customer implementation stories--it truly was a SharePoint summit. I spoke with many people who told me the only reason they came was to see SharePoint 2010. Their goal was to learn how to enhance what they were already doing with SharePoint or how to migrate from their existing solution and begin to embrace the SharePoint 2010 technology. One vendor told me the only reason most of the vendors returned, including them, was because the focus of the show would be on Microsoft’s flagship product.

Case in point, the Microsoft booth was buzzing with SharePoint solutions solving all kinds of collaboration and ECM problems. It is undeniable that SharePoint has changed the landscape of enterprise content management. In the 2005 Magic Quadrant for ECM, Gartner showed Microsoft at the top of being a niche player with and ability to execute. In 2009 Gartner showed Microsoft in second place under the Leadership quadrant. I would be surprised to not see Microsoft in the number one position this year. One thing is truly for sure; they absolutely stole the show at AIIM 360 this year.

Bryan Reynolds is Managing Partner of Sitrof Technologies, 700 Alexander Park, Princeton, NJ 08540, email: breynolds@sitrof.com

A global pharmaceutical company and Sitrof client uses FirstDoc R&D for managing their FDA submission content.  After acquiring another life sciences company that were left with submission content in three disparate content repositories; one in FirstDoc and the other two lightly customized versions of Documentum. The company tasked Sitrof with defining the migration mapping requirements, evaluating configurations and customizations in the source system and implementing a technical solution in order to migrate this mission critical  content and metadata.

Key points to consider when performing such a migration include:

• FirstDoc Object Model
• Migration of FirstDoc Configurations
• FirstDoc API
• FirstDoc Migration

FirstDoc Object Model

When performing a migration from one FirstDoc system to another, it is important to remember that FirstDoc interfaces rely on the FirstDoc object model to function correctly. The FirstDoc object model for the FDRD module is reproduced below:

All objects that extend from the fdk_document type are recognized by the FirstDoc interface to be FirstDoc documents. If types are to be mapped from one FirstDoc system to another, this is important since mapping to a type that does not extend from fdk_document will cause the document to become a normal non-FirstDoc document.

Properties of the fdk_document in all FirstDoc:

FirstDoc extends the Documentum Type architecture to Subtype, Unit, and Subunit. Thus, a mapping of the Types, Subtypes, Units and Subunits is required from one system to the other. This is usually achieved in the requirements gathering phase, after mapping has been decided upon. Furthermore, each FirstDoc module has other special mapping requirements which are unique to each module. For example, in the FDRD module, all FirstDoc documents extend from the r_and_d_document type which has the required attribute ‘product’. Each unique product is associated with a Product Dictionary in the FDRD system.

When migrating from one repository which has a different set of products to another, all product dictionaries must be created from the source system in the target one. Products may also be mapped from the source system to the target one in which case a new product dictionary does not need to be created. This is illustrated below:

For a successful migration of all documents, all products must be completely mapped or created in the target system since the FDRD module will not allow documents to have products which do not have a Product Dictionary.

Migration of FirstDoc Configurations

FirstDoc is a client-driven enforcement of server-side configurations, meaning that all FirstDoc rules and security are enforced at the Web layer. The rules are implemented and stored in the Content Server. Every FirstDoc configuration is associated with at the minimum a Type and a Subtype and at maximum the Unit and Subunit.

During migration, this presents us with two scenarios:

• All Types and Subtypes are mapped completely from the Source System to the Target System. In this case, migration of FirstDoc configurations might not be necessary--unless the configurations from the Source System to the Target system are in conflict with each other. In this case, the business owners of the source system and the target system must decide which configurations to keep.
• Some Types and Subtypes from the Source system are created as new Types and Subtypes in the Target System. In this case, the configurations associated with these type-subtypes might have to be migrated to the Target System. These new type-subtypes must also be added to the FirstDoc Dictionary of the Target System. To assist in the migration of the configurations, the FirstDoc CMU Tool could be employed.

FirstDoc API

FirstDoc provides developers with an extensive set of JAVA API to perform many of the server-side functions that are executed upon user-interaction. For the purposes of migration, only the API related to the following two functions are important:

• Refoldering API: Documents in FirstDoc are foldered according to their Type and Subtype. This is stored in a FirstDoc configuration. During import of the documents, one must run the Refoldering API so that the documents are foldered at the right place.
• Security API: Documents in FirstDoc inherit their ACL according to their Type and Subtype. This is also stored in a FirstDoc configuration and during import of the documents, one must run the Security API so that documents attain the correct ACL according to the FirstDoc rules.

The flow of the Import program is thus illustrated as below:

FirstDoc Migration

This section summarizes all the above points and provides a visual for the overall FirstDoc Migration:

Microsoft SharePoint is an Enterprise Content Management (ECM) tool that enables organizations to collaborate efforts and work more efficiently as a cohesive unit, through shared knowledge, documents, workflows, metrics and structure. One of the most commonly noted benefits of implementing SharePoint as an organization’s ECM tool is end-user familiarity. As SharePoint is a Microsoft product, users tend to adapt quickly to the program due to its familiar Windows-based look and functionality.

Organizations considering implementing a content management tool should keep in mind the impact on compliance and governance SharePoint has provided its users. For organizations in highly regulated industries (i.e. life sciences, financial services, government, etc.) compliance, both internal and external, remains a top priority. The four key areas they must consider when adopting a SharePoint environment are: authentication requirements; restricted access to personally identifiable information; permission based, secure login only access to such sensitive intellectual property; and data retention.

Before deploying a SharePoint environment, companies need to create a governance plan to step up an information architecture structure and an enterprise search strategy. This governance plan needs to outline user policies, set guidelines for appropriate applications, and content and standards for review. This plan will enhance the organizations collaboration efforts and maintain consistency, thus obtaining the most out of the intranet. The plan must identify key roles and responsibilities, and set up lines of communication between managers, administrators and standard users; this will identify permission statuses and identify where restrictions need to be set.

Defining the information architecture will help to increase user access to the relevant information. Faster, accurate information retrieval will result in increased productivity and enhanced collaboration capabilities. The framework of the information architecture should be built in advance, starting with basic uniform pages including the home page, the procedure and policy outline page, the search page and a department page. These pages will be the most commonly accessed, landing pages for the system. Creating a site map defining the structure of the site, by department, will help to organize all sub-pages and what intellectual property will be housed in each.

The team developing the governance plan will also need to set taxonomy guidelines, so consistent naming conventions will be used when labeling documents. A pre-determined group should be responsible for controlling the taxonomy so it is maintained and consistent. This will help to standardize the site and allow for more efficient and accurate searches.

Consistency throughout the site is crucial to its effectiveness; this includes the appearance or branding of pages across the site. A consistent look makes users aware that they are in fact on the company intranet, and as the look of higher level pages can be tailored with sub-branding to reaffirm with users working on these pages that they are in a restricted area. SharePoint has a ‘master page’ feature to ensure a consistent look and create a standard page design and layout elements that will be shared by all pages. The layout elements can include navigational controls, company logo, copyright notices, disclaimers, etc; if these elements require updating it can be done via the master page instead of on each individual page.

The governance plan must include an official approval process to ensure compliance. It must also establish user policies that render areas with sensitive intellectual property restricted and require higher levels of security to access these areas. User policies will establish who can access, edit and add to content in restricted, high security areas. This policy must also establish security measures for accessing information remotely. System back-ups and testing are also key elements of the governance plan. Scheduling regular system back-ups and setting schedules for regular content review provides necessary security for the site. Test plans should also include checking all of the systems functionality to ensure all capabilities are running efficiently.

Extensive training needs to be mandatory for all users to ensure all of the aspects of the governance plan are being met. In addition to general policy and procedure training that all users must receive, training will need to be tailored to meet the needs of the different user groups; for example site managers will require a more in depth training detailing policies and set-up procedures, whereas end users will need training geared toward the functionality of the tool and key areas like search capabilities. All users need to be trained to maximize collaborative efforts and learn the key features of the system to help them work smarter and more efficiently. Users will need to be trained in how to connect to the server remotely and access information off-site to maximize productivity. Documenting all training and providing the documentation to all users is essential in managing an ECM tool.

With a well thought out governance plan established, implementing a SharePoint environment is a seamless, effective way to increase productivity and collaborative efforts throughout an organization. If planned effectively, SharePoint can be put into place with minor to no noticeable disruption of the business. As the cost of implementing a SharePoint environment is significantly lower in contrast with its competitors, and the Windows-based application is something users are familiar with and instantly identify and feel comfortable using, this tool is a wise choice when selecting an ECM tool.