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21 CFR Part 11

The life sciences industry is challenged with increasingly stringent regulations, requiring enormous volumes of documentation. Electronic document management has helped to streamline these documentation processes, and the way in which it is governed is known as 21 CFR Part 11.

Xythos content management platform meets 21 CFR 11 guidelines by:

• Providing Central Repository To Store, Manage and Share Documents: Xythos provides a secure, scalable, enterprise solution which can collect and manage thousands, even millions, of documents. No matter where a document originated—a scientist’s laptop, a scanner, or even automated test equipment—Xythos can help capture and store this information. Xythos also provides a variety of document management features, including file-level security, integration with LDAP, document version control, and file auditing and locking, which can help organization’s consistently manage information control policies. When it comes to sharing documents, Xythos makes it easy and safe. Xythos allows encrypted links to files and documents to be sent to users inside and outside the organization—eliminating the risks associated with email attachments.
• Securing and Maintaining Documents and Emails As Records: 21 CFR 11 mandates that organizations define and maintain records of any document that is a significant part of the research and development process, including: research protocols, results of experimental trials, and logs of regular maintenance for research equipment. Xythos Enterprise Document Manager allows documents, emails and content of all types to be stored as records according to the U.S. Department of Defense 5015.2-Standard for integrated records management systems. Users can define and modify Document Classes, Document Class Properties, Retention Rules, Permission Templates and more— in accordance with this regulation. Xythos also allows emails and attachments to be archived as records, permitting them to be searched, filtered and reported on.
• Providing an Audit Trail: According to 21 CFR 11, every record must have a history of who wrote, edited, and read research related documents. The change history of key documents also must be preserved so that regulators can reconstruct every aspect of a research project. Xythos provides both document versioning and auditing features to help maintain the complete history of a document, including its earlier drafts. Users can also configure directories so that auditing and versioning occur automatically. With comprehensive access logging, record managers can audit all records and actions performed on records throughout the Xythos system, helping an organization adhere to 21 CFR 11.