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

CGIRB uses a secure Web-based portal with DocuShare to manage large volumes of electronic paper documents related to client studies and compliance audits. The ECM solution has saved CGIRB an estimated $160,000 annually on shipping, supplies and personnel costs, and has reduced the time to process requests from an hour to minutes. Before, CGIRB manually printed and shipped documents to multiple locations for review and filing – a timely and costly process.

“Federal guidelines require CGIRB to retain files up to 10 years, so we needed a solution that would eliminate the drain on our resources. DocuShare software has done that and helped us be more efficient and competitive,” said Jennifer Sodrel, director, Information Management, CGIRB.

The review board gains further efficiency and control by using a DocuShare Compliance Module, created by Sitrof Technologies, which generates a complete audit trail of edits made to each document, including when and by whom. It also offers e-signature capabilities that comply with pharmaceutical industry regulation FDA 21 CFR Part 11, and eliminates the need for written signatures.

“Paper-intensive organizations such as CGIRB are taking control of their documents, rather than feeling overwhelmed by them,” said David Smith, vice president, DocuShare Business Unit, Xerox Corporation. “With DocuShare, CGIRB has transformed its workplace – allowing them to concentrate on their core business while slashing costs, decreasing turnaround times and improving data accuracy.”

Click here to see CGIRB video case study.

Click here to read full case study.

About Xerox DocuShare

Xerox DocuShare is an enterprise content management platform developed by Xerox Corporation. DocuShare’s capabilities range from basic content services to more robust business process automation and paper-to-digital solutions. It offers a number of partner solutions for vertical and cross-industry business processes. See full release at Xerox Newsroom.

DOCUMENT Strategy Forum (Chicago-September 13-15)  features the most comprehensive conference focused on connecting everyone within the enterprise who is responsible for the transactional document performance from Creation, Production, Delivery (Mail/Electronic), Remittance, Preservation and Management. Attendees will have the opportunity to spend up to three full days networking, learning and meeting with companies that understand the unique and ever-changing challenges.

DOCUMENT Strategy Forum will honor its “Preferred” pricing program through June 18th which means you can still save up to $300 on your conference registration.  Click Here for Registration.

As I was traveling back from the symposium, I could not help but think about all the great case studies I heard.  I was grateful that Xerox Canada asked Sitrof to speak at the event. We heard some great stories about how a whole host of different companies are leveraging the functionality of Xerox DocuShare.

Kellie Barron, of  Kawartha Pine Ridge School Division, spoke about their five-year strategic model for document and records management. She shared their road map to document success and how their partnerships with Xerox has resulted in a unique licensing structure and a staged approach to DocuShare adoption.  She also shared how Sitrof helped them migrate from EMC Documentum to Xerox DocuShare and the great success of that project.

We also heard from Mike P. Gagel and Maggie Li, of the BC School Trustees Association. They spoke about the evolution of BCSTA DocuShare and how they earned user acceptance through targeted training.  One of the key tools they were using for training is called Camtasia Studio.  They demonstrated its features and how they used it to record and deliver Xerox DocuShare training.  I did further research on the tool and determined it is an inexpensive and easy to use screen capture tool that allow you to easily create robust video demos.  I thought this was a great find.

Another interesting presentation came from Judy Cameron, of Canadian Union of Public Employees (CUPE), one of the largest unions in Canada.  CUPE is using DocuShare to manage its electronic documents, creating a virtual research library and managing its records, archives and e-mail through Xerox DocuShare. How  interesting that they are using traditional library bibliographic control to manage the thousands of publications and records produced by CUPE yearly.  Because of this indexing, they can quickly find needed documents--making the deployment a success.

After lunch we heard from Mark Bamford of Edmonton Northlands.  Northlands is in the business of producing major events to venues all over Canada. He spoke about why document management is so important and how it allows Northlands to manage its business better. I enjoyed learning more about their relatively large implementation and how they approached eating the elephant--implementing a large project--one bite at a time.  Much like the others, they chose to move forward with precaution, good analysis and a phased approach.  This has created a great experience for all users of the system and strong ROI for the business.

Once Mark was done, it was my turn to present.  I spoke about one of our customers, Copernicus Group IRB, and their case study defining how they achieved a 95% paperless office while remaining 100% Compliant. I discussed their back-file scanning project of 5 million pages of legacy documents, the elimination of printing incoming electronic documents and their automated all paper processes and workflows including electronic routing and digital signature approval with Xerox DocuShare and the Sitrof Compliance Module.

Click here to see the slides:  Sitrof-Copernicus-Case-Study

One element of the symposium that really rang true had to do with phased deployments.  Every case study detailed how they deployed the solution one phase at the time.  This is key to their success.  The best way to move forward with any document management deployment is with proper planning.  It is very important to make sure you allow enough time for strong requirements and design. Furthermore during the process, involving as many users of the system in the beginning ensures that you can achieve total buy-in for the solution.  Over the hundreds of implementations I have been involved in, we have found with these fundamental project principals in place,  you can always achieve success.

I am already looking forward to next year, thank you to all who contributed at the symposium!

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 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.

In addition to discussing measurable ROI, Mr. Mitchell spoke about huge returns that are more difficult to quantify, such as compliance which he said is "priceless".  Copernicus is now 99% paperless using DocuShare with the Sitrof Compliance Module for 21 CFR Part 11 compliance.

In response to "have we gotten any better at measuring ROI in Enterprise Content Management (ECM) systems?" Mr. Wheeler replied, "I think we are forced to get better in these economic times, every company Sitrof talks to is scrutinizing their purchases--so unless we can demonstrate ROI in these solutions, they are not going to buy. It is important that we help them come up with those hard cost savings."

The full podcast is available from Xerox here.

Sitrof will be live-tweeting this discussion and podcast on their Twitter account. A link to the podcast will be available from Xerox soon.