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.
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.
- 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.
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.
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.
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.
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.
CGIRB’s award-winning 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.