Biotech Firm Implements Efficient Document Management System to Meet Compliance Needs
A leader of in-vitro diagnostics, Roche Diagnostics manages a vast and expanding volume of molecular insights and translates it into products with high medical value for physicians and patients. Because of the complex and detailed nature of this work, Roche Diagnostics has stringent requirements for document management and storage.
The company wanted to replace its existing document management system for IT projects with a new solution offering a more robust feature set. With help from Microsoft® Gold Certified Partner, Alegri International, Roche Diagnostics built a solution based on Microsoft Office SharePoint® Server 2007, providing comprehensive security features, workflow support for the entire document life cycle, and automated PDF rendering and publishing. The solution is designed to comply with strict U.S. Food and Drug Administration regulations.
Roche Diagnostics and its innovative diagnostic tests and systems play a pivotal role in integrated healthcare solutions, covering the early detection, targeted screening, evaluation, and monitoring of disease. With more than 18,000 employees worldwide, Roche Diagnostics is active in all market segments, from scientific research and clinical laboratory systems to patient self-monitoring.
Roche Diagnostics decided it was time to replace its aging EMC Documentum-based software for managing and storing electronic IT documents. “We set out to take advantage of the possibilities offered by a new cutting-edge document management solution,” says Dr. Erich Weyrauther, Head of Content Management and Collaboration at Roche Diagnostics Global Informatics.
Because its work involves the development of in-vitro tests, Roche Diagnostics is required to adhere to strict regulations set by the U.S. Food and Drug Administration (FDA). Any document management system used would need to comply with Part 11 of Title 21 of the U.S. Code of Federal Regulations (21 CFR Part 11), which determines the rules for electronic records. The rules cover system access authorization, document audit trails, electronic signatures, and validation requirements for computer systems.
Roche Diagnostics had other requirements for its new IT document management solution as well. The organization wanted to be able to:
- Easily manage, update, and publish documents using the company’s intranet
- Automatically generate Portable Document Format (PDF) versions of documents, including cover sheets containing complete metadata
- Provide reference links between documents stored in different locations
- Implement a consistent document storage structure
Ease of migration would be a key selling point for any candidate solution because Roche Diagnostics had more than 100,000 documents in its existing system, including multiple versions and metadata such as project association, document owner, and workflow data. These documents had been created, edited, and archived by 3,000 employees worldwide using approximately 120 applications spanning 350 projects. “It was a huge challenge,” notes Simona Scheele-Cretulov, Senior Enterprise Document Management Consultant at Roche Diagnostics.
Roche Diagnostics enlisted the help of consultants at Microsoft® Gold Certified Partner Alegri International to implement a new IT document management system. The team felt that Microsoft Office SharePoint® Server 2007 offered the functionality needed to build a robust, feature-rich solution. “The outstanding user-friendliness and collaboration features of Office SharePoint Server 2007 within the familiar Microsoft Office environment were incredibly compelling,” says Scheele-Cretulov.
To efficiently organize information within the new system, the team used the site collection capability in Office SharePoint Server 2007 to implement a document hierarchy that corresponds to real-life project organization. Each site collection represents an application; the documentation for associated projects is stored in folders that follow an IT project management methodology. Documents spanning multiple applications can be managed at higher levels.
Because a single document may be needed for several projects at the same time, Roche Diagnostics created an intelligent linking mechanism to allow users to reference valid documents and their metadata from multiple projects. This way, employees do not need to maintain multiple versions of a document. Office SharePoint Server 2007 ensures that file permissions are observed so only authorized users can make edits.
Permissions are assigned to users according to a team-based security concept. There are three user groups that can perform different tasks, depending on their permission level: Reader, Contributor, and Manager. Readers can only view documents, Contributors can create and edit documents, and Managers can also perform administrative tasks related to their projects.
Beginning with the draft version, documents follow a tightly controlled life-cycle workflow that typically includes multiple approval cycles and ends when the workflow specifies that the document should be retired. Only users with the appropriate permissions are included as part of the life-cycle workflow. These users receive e-mail that informs them of required actions and provides a link to access the documents. Within Office SharePoint Server 2007, users can view documents, approve them if necessary using an electronic signature, or decline them and provide comments.
The system saves all signatures used in the workflow alongside the relevant version of the document. At any time, users can see who approved which version, when, and their respective role. In addition, the solution is integrated with Adlib Express to automatically generate a PDF version of each completed document, containing the original content and all relevant workflow data.
Documents whose content becomes obsolete and should no longer be used are locked down to prevent further editing. The documents are still available for viewing for archiving reasons, but they can no longer be edited.
Overall, the implementation of the new document management system took about six months. The old and new systems existed side by side for about a year. During that time, existing projects and their documents were migrated, and retired documents were archived. “Using Office SharePoint Server 2007, we implemented a highly complex IT project in a reasonably short time,” says Scheele-Cretulov.
Roche Diagnostics built a robust document management solution that makes it easier for employees to manage their IT documents, create PDF versions, and publish them on the company intranet. The new system is designed to comply with all applicable FDA regulations.
Improved Document Management
Roche Diagnostics employees can easily manage and update documents associated with their projects. The documents are accessible from a Web site where users can view them or check files in and out for editing. Employees can rely on the solution’s workflow capabilities to ensure that documents follow the appropriate route for editing and approvals, and that two team members never end up working with different versions of the same document, which could result in version conflict or data loss.
Automatic PDF File Generation
Within the new document management system, approved documents are automatically converted to unalterable PDF files when the workflow is complete. Each PDF version contains the original content and a cover sheet with all the relevant workflow data. “This was very important for us,” explains Scheele-Cretulov. “The cover sheet printed with the PDF file shows immediately which document version was printed, who approved it, etc.”
After the PDF version is generated, the system automatically stores the file associated with its project in the document repository and links it to its source document. Users can retrieve and view the documents at any time.
Simplified Intranet Publication
Roche Diagnostics employees can easily publish approved documents by using a link on the company’s intranet. This makes the files available to users outside the document management system, and it avoids administrative headaches associated with managing local copies of documents.
The new IT document management system was designed and implemented to be fully compliant with all applicable FDA 21 CFR Part 11 regulations, and was successfully audited by an independent expert after project completion.