Background

Copernicus Group IRB (CGIRB), with assistance from Sitrof and employee-driven change management, was able to transform from an entirely paper-reliant company with millions of pages of legacy documentation into a completely digital paperless organization in less than two years. As a result, the company dramatically reduced expenses and created a truly “green” work environment by nearly eliminating paper, printing, storage, shipping and other hard document handling costs.

With a three-phase implementation approach, employee-led review and oversight committees, CGIRB fostered a positive, productive atmosphere for long-term change management. CGIRB gained competitive advantage and improved service to pharmaceutical clients by becoming more efficient in review and approval process—thus enabling clients to accelerate their study start up and increase the speed in getting drugs approved and into the market.

The Challenge

In the fall of 2006, CGIRB sought a document management solution to handle incoming electronic documents so they did not have to be printed and circulated in hard copy. It approached Sitrof Technologies, a company specializing in unstructured document management with extensive experience Part 11 compliance. CGIRB wanted to install a 21 CRF Part 11 compliant document management system with workflow, version control and electronic signatures to handle incoming documents.

CGIRB is an IRB which under FDA regulations means it’s an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. Running the day-to-day business at an IRB is incredibly paper intensive and requires a great deal of internal and external collaboration. But by 2006, 96% of incoming documents to CGIRB were received electronically via digital fax, portals and email—and then printed out because CGIRB did not have a FDA 21 CFR Part 11 certified process for electronic document handling.

CGIRB knew something had to change in this process and set to work with Sitrof to implement a solution to becoming paperless.

Initially, CGIRB only sought a way to handle incoming electronic documents, and nothing more. However, early in the investigation process, CGIRB realized it was entirely possible to become a completely paperless company and so established a very aggressive goal of doing so. This paperless evolution would involve 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.

The project also required extensive system integration with CGIRB’s internal Protocol Tracking Systems and its customer-facing portal, Connexus. It also necessitated reengineering and converting of the company’s existing paper processes and workflows—which in turn necessitated a critically important cultural/change management solution for CGIRB employees.

Objectives included:

• To install a 21 CRF Part 11 compliant document management system with workflow, version control and electronic signatures to handle incoming documents.
• To improve efficiency, reduce the need for paper (cost, storage and environmental reasons) and most of all, improve their competitive advantage.
• Overall objective was for CGIRB to become a paperless company.

The Solution

To transform CGIRB into a paperless company, Sitrof undertook 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. Due to the requirements of 21CFR Part 11, CGIRB must validate all regulated systems. Each of these phases included documentation and validation effort to ensure CGIRB systems remained in an appropriately validated state.

Sitrof worked with CGIRB to create an efficient and successful implementation process using a three-phase approach.

• Phase One: Using DocuShare out of the box.
• Phase Two: Scanning and uploading 5 million legacy pages to an e-file room for viewing purposes only.
• Phase Three: Adding Sitrof’s Compliance Module to DocuShare to automate the workflow and decision process for electronic records while maintaining Part 11 compliance.

Phase One:

From the very start, CGIRB improved employee adoption and buy-in immeasurably by creating subcommittees, focus groups, team meetings and best-practices teams from lines of business and IT. In mid-2008 Sitrof installed Xerox DocuShare software for use with CGIRB’s non-regulated documents, such as vacation requests, business development information, training information, PowerPoint presentations, spreadsheets, status reports, RFIs and contracts. Employees quickly became familiar with the DocuShare interface, easing them out of their comfort zone in a non-threatening, time-relaxed manner.

Subcommittees, focus groups, team meetings and best practices teams involved as many staff members as possible. Phase One also allowed CGIRB and Sitrof to fine-tune processes and customize the software before launch, again minimizing risk before full implementation.

Phase Two:

To become truly paperless, a major legacy scanning operation was necessary. CGIRB commissioned a local established outsource firm, SCDATA, Inc., to work on-site, scanning, indexing and archiving 5 million pages of legacy documents (more than 200,000 pages scanned per month). Proper check-in/check-out of these live paper documents was essential throughout the conversion process, because at any point in time, CGIRB had to be able to locate any specific document—even if it had already been pulled for scanning.

Initially, the scanned documents were available through a DocuShare e-file room for “read only” purpose. This allowed users to become familiar with the system and working with electronic records. However, because the system was not yet Part 11 compliant for decision-making, the original paper was still routed to board members. Thus by the end of phase two, and before full launch, users already had nearly a year’s worth of hands-on experience with the system.

In addition to making a certified and trustworthy duplicate through scanning, Optical Character Recognition (OCR) was applied to each page, converting it to digital text and allowing full text search of all 5 million pages of documentation. Adding OCR and full text search was very forward thinking on part of the team and resulted in further streamlining of the clinical research process. Each document was also compressed to within 5% of its original size. The OCR and compression process continues today for all newly entered hardcopy and electronic documents.

Phase Three:

Both CGIRB and Sitrof knew from the start that Xerox DocuShare alone would not meet all functional requirements for a new paperless system, including Part 11 compliance. Yet, by design, it wasn’t until a full year later—after thorough testing with non-regulated documents, working through process changes and getting buy-in—that Sitrof installed its Compliance Module to ensure 21 CFR Part 11 compliance. Until that point the mission critical documents were still being handled in paper.

DocuShare, when combined with the Sitrof Compliance Module, is a robust document management collaboration tool supporting CGIRB’s mission critical function.

The Results

CGIRB’s paperless evolution is green, efficient, cost-effective, compliant and competitive. With over 96% of documents received electronically at CGIRB, eliminating the need to print documents reduced cost and allowed for a green work environment. An ROI of 51% represents the implementation of CGIRB’s DocuShare paperless environment.

By scanning and performing OCR all the 1.5 million documents in the legacy repository can now be searched in a Google-style manner by the DocuShare software. This enables board members to quickly find the right passage in typically 200-page long protocols and investigative brochures. In addition to the time savings, the risk of missing something is virtually eliminated.

In the past, thousands of approval documents and correspondence were shipped out to sites and clients each day. Now, with updated SOPs and the technology in place to exchange electronic documents, paper is conserved, shipping costs are reduced and approval documents can be accessed instantly.

Because study documents are dynamic documents that are never fully retired, they can be in use for more than ten years. Converting all paper to digital dramatically expedited the retrieval process of these valuable documents and nearly eliminated hard storage costs. CGIRB no longer risks losing paper documents, and a single document can easily and securely be shared among numerous board members.

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:

Background

Founded in 1882, our client is a leading provider of commercial, specialty and personal insurance to customers worldwide. Our client ranks among the Top 10 publicly traded insurance organizations, based on revenues, in the United States. With more than 10,000 employees throughout North America, Europe, South America and the Pacific Rim, our client serves property and casualty customers from more than 132 offices in 33 countries. Our client works closely with 5,000 independent agents and brokers worldwide.

Business Challenge

The insurance industry is currently undergoing a high degree of change. Carriers are challenged to post an Underwriting profit. Government deregulation is enabling new competition from traditional Financial Services companies, who are now able to market products to their customers which in the past, had only been available from Insurance companies.

Fierce competition, product commoditization and catastrophic losses are increasing pressure on eroding margins. Leading companies are exiting unprofitable business lines and streamlining expenses. At the same time, agents, brokers and consumers are demanding specialized products, high quality services and access to information from any location, using any medium at any time. Accordingly, carriers are leveraging information technology to:

• Reduce costs because the bottom-line counts now more than ever
• Increase efficiency by streamlining and automating manual processes
• Improving productivity
• Create new demand for products
• Enhance services to keep one step ahead of the intensifying competition

Objectives

Our client needed to integrate existing fax servers so that all incoming faxes would be received and routed to a centralized document management repository. Furthermore, our client needed to have the fax index information automatically stored on the document when it was filed. In addition, our client required a robust Lotus Notes integration to allow users to add incoming and outgoing email to the document management system. Finally, our client also had the need to implement a distributed and easy to use imaging solution.

Technical Solutions

Sitrof Technologies, Inc. was able to build a system that met all of the user requirements. The system consisted of a .NET architecture with HTML/LotusScript, and Visual Basic user interface. The applications connected to and retrieved the documents from a newly implemented document management repository. Faxes came in through their Zetafax Fax Gateway Server and routed to the inbox in Lotus Notes. Users were able to select one or more e-mails/faxes from a desired folder. The users select an integrated menu option, prompting with an input screen. The screen is used to classify (document type) the emails/faxes and enter any relevant metadata required from the document management server. Sitrof also customized and implemented their scanning solution and integrated a document classification/acl schema to the chosen document management server in accordance with the user and functional requirements specification.

Results

Our client is now able to eliminate most of the paper documents in their process and have web-based access to all their documents on time and without problems. What used to take minutes or hours now takes seconds. They are now confident that all the documents are sent to their customers and if any problems do arise, they can respond in minutes as opposed to hours and days. The project was completed on time and within budget.

Background

The Public Employees' Retirement System was established in 1955. The Division of Pensions and Benefits is assigned all administrative functions of the retirement system for investment.

Business Challenge

To redesign and develop a workflow system to be used by the Division of Pensions and Benefits to process the purchasing of retirement time. The original system had become old and outdated and was no longer going to be supported by FileNET. This system, originally developed using the FileNET WorkForce Desktop 4.0 scripting language, needed to be rewritten to use the latest FileNET Visual WorkFlo.

Objectives

• Redesign and develop a workflow system to manage the retirement process of municipal and state employees.
• The new system required a tight integration to the IBM Mainframe, Oracle Databases, and UNIX FileNET imaging repositories.
• A sophisticated automated letter creation module was required for correspondence to state employees.
• The new system had to be Y2K compliant.

Technical Solutions

Used FileNET Panagon to develop a client-server based solution.

Application

Customized application interface containing all of the needed information for the Purchasing group to process their work. It included imaging which allowed the user to access documents scanned in as well as storing correspondence printed from the custom letter generation service. The applicant would start the process by submitting an application which would generate a work object. As the work object traveled through the workflow, different users would interact with the data. In the event of certain flags produced by that interaction, the system would automatically generate correspondence which was printed on a nightly batch process server. Once the applicant was approved a form was generated and sent to the payroll department so that they could begin deducting the agreed amount from the applicants biweekly or monthly pay checks.

Tools

Visual Basic for customized components. FileNET's IDM Desktop API's and Visual WorkFlo.

Results

• Applicants are now reviewed and approved 50% faster.
• Fewer mistakes are made during the process.
• The administrator now has the ability to reassign workload to different users decreasing the bottleneck when someone is out on sick leave or vacation
• Users now have timely access to the documents needed to process the work.
• Pre-defined from letters can be pre-populated from the applicant's information as stored in the FileNET System.

Background

Our client is a major international consumer products company. They worked with an Application Service Provider (ASP) who contracted with them to hold and supply all of their MSDS documents. Due to poor service from the ASP they wanted to create a custom system allowing them to manage their own access to the MSDS documents.

Business Challenge

Our client wanted to leverage their existing Documentum repository where the MSDS documents already existed. In addition they wanted to create a Web-Based application for their users to access the documents. The site needed to be able to print, fax, or email large amounts of documents as well as track each request.

Objectives

• Deploy application in Piscataway, New Jersey for use by the Consumer Affairs division located in New York City, New York.
• Leverage the existing Documentum DocBase located in Piscataway, New Jersey.
• Build a Web-Based Architecture with a consistent user interface across all desktops.

Technical Solutions

Sitrof Technologies, Inc. was able to build a system that met all of the user requirements. The system consisted of an ASP/COM+ architecture with HTML/JavaScript user interface. The application connected to, and retrieved the documents from their existing Documentum DocBase and handled all of the reporting requirements.

Results

Our client is now able to access the MSDS documents on time and without problems. What used to take minutes or hours now takes seconds. They are now confident that all the documents are sent to their customers and if any problems do arise; they can respond in minutes as opposed to hours and days. The project was completed on time and within budget. In addition, the project won a company award for the Best Managed Project of the Year.

Background

Our client is a pharmaceutical business unit of Akzo Nobel NV, a multinational company based in the Netherlands. Today, our client has nearly 10,000 employees and is active in more than 100 countries.

Business Challenge

Our client's West Orange, NJ, facility faced a growing challenge of managing their Standard Operating Procedure (SOP) documents. With the volume of documents increasing at 20% per year, their paper-based approach was very labor-intensive, expensive and error prone.

Objectives

Create an electronic document management system that will accomplish the following:

• Decrease review and approval times
• Reduce copying and shipping costs
• Provide better reporting capabilities.

Technical Solutions

Sitrof Technologies, Inc. used Documentum 4i server with customized Desktop Client (DTC) front-end.

Application

Customized DTC components such as Check-In, Properties, and Task Manager. New DTC components such as Reassign Tasks, Pull Reviewer Tasks, and Submit Change Request.

Tools

Visual Basic for customized DTC components. Active Server Pages and XML for web based workflow reports.

Results

• Documents are now reviewed and approved 50% faster.
• Thousands of dollars a year have been saved in photocopy and shipping charges.
• Web-based workflow status reports eliminate the need to track down who is currently working on a document and gives the Document Administrator the control to improve productivity.
• Electronic sticky notes make it easier for document authors to read reviewer comments.
• Electronic backups reduce the amount of storage space needed SOPs available to all users via the company Intranet.

Closing Statement

Sitrof built a custom electronic SOP system that has greatly reduced the amount of time spent reviewing and approving documents. This has allowed our client to re-deploy resources that were previously dedicated to make photocopies and collecting hand signatures.

Background

Our client is a global pharmaceutical company headquartered in Kenilworth, NJ. Our client has over 32,000 employees worldwide and sells product in over 120 countries.

Business Challenge

The Clinical Documentation department Within the Research Institute was drowning in paper. As a result of an increasing number of Phase III studies, the number of case report forms and other study related documentation was growing dramatically A content management solution was needed to manage the high volume of documents created.

Objectives

• Provide a solution to manage the increasing amount of paper
• Provide a solution for generating microfilm for long-term archive purposes
• Provide a solution for generating bookmarked PDF files that the Regulatory group could include in FDA submissions

Technical Solutions

An InputAccel imaging solution was implemented for scanning up to 10,000 pages a day. These images were stored in a Documentum repository and access through a custom PowerBuilder front-end. A custom microfilm module was developed to ensure all images that were put into the repository could be microfilmed with the Kodak ArchiveWriter. A custom PDF export tool was also developed that published multiple case report forms and data correction forms into a single PDF file that was bookmarked by visit, module and discrepancy.

CYA HOTBackup was later implemented to provide hot backups of the Documentum repository to minimize data loss in the event of a disaster.

Results

As a result, documents can now be found much more quickly since they are available electronically. Less office space is needed for storing documents since they can be shipped to long term storage as soon as they scanned.

Background

Our client is on of the oldest and largest wealth management firms in the United States managing over 33 billion dollars in assets for over 1,800 clients. Our client is universally recognized for the depth and quality of the personal service they provide their clients.

Business Challenge

The challenge was to migrate an outdated non-supported Watermark Imaging System into a FileNET Panagon IDMCS Document Management System. This required converting 1 million documents from the legacy system into FileNET Panagon. In addition, both systems had to run in parallel over a three month period during the enterprise roll out.

Objectives

• Migrate an outdated legacy system
• Create a new Web-based document retrieval application
• Create a new Scan Application to interface with the new Document Management System
• Create a Backend batch process to sync data from the Legacy Mainframe application and the Web-based document retrieval application

Technical Solutions

Used FileNET Panagon to develop a Web and Client-Server based solution.

Application

Created a series of three major applications. The first was a robust migration tool which was used to migrate the documents stored in two Watermark systems (Palm Beach, FL and New York City, NY). This process was ongoing through the entire project.

The second application was a robust web-based retrieval system that adhered to the complex business rules of the client. It gave the users the ability to view documents, add electronic documents, create barcode scan header sheets, change properties, email documents and sort them in many different views.

The third application was a custom client-server scan tool which leveraged the FileNET Capture toolkit. This application could process barcodes off of the scan header sheets, get the information from an Oracle table, and commit the document with minimal user interaction. The scan application followed the process of Doc Prep, Scan, Image Verification, Doc Processing, Indexing and Committal.

Tools

Visual Basic, Active Server Pages, MSXML. FileNET's IDM Desktop API's and Capture Scan Module

Results

• Users are able to add information directly from their hard drives into the repository in much less time than before.
• Users are able to retrieve the information in a tenth of the time it took with the old system.
• Scanning throughput increased by 200% with the new automated process.
• The number or rejected scan header sheets went from 50-100 per month to 1-2 per month.