FDA 21 CFR Part 11 Regulatory Compliance
As 21 CFR Part 11 requires ongoing attention in order to maintain compliance, BP Logix is delivering software allowing its clients to address the requirements of this regulation. Further, BP Logix understands that interpretations of FDA Title 21 CFR Part 11 may differ from company to company and sees this as an opportunity to continue to build on its 21 CFR Part 11 compliance portfolio.
It is BP Logix’s commitment to provide its clients with the best technology solutions for document management and workflow. The senior management of BP Logix will make every effort through good technology practices and internal operating procedures to develop and utilize systems which comply with interpretations of 21 CFR Part 11, and enable customers to establish compliance.
The regulation’s premise is to maintain proper identifiers for electronic data relevant to product safety, purity and efficacy. Just as printed documents provided a paper trail through the product life cycle, computer records need to create a similar electronic trail, identifying users, approvals and progressions that lead back to the original data.
BP Logix products provide comprehensive security management and auditing features that enable your organization to maintain compliance with 21 CFR Part 11.
- User authentication supports your existing compliant security systems (e.g. Windows Domain Security, Windows 2000 Active Directory, LDAP, etc.);
- Only authorized users have access to sensitive information;
- A predefined, automated workflow process provides consistent review, approval and update procedures for all content;
- Document version control maintains the identity of any user who modifies a document;
- A document history maintains every workflow run against a document, showing not only who updated a document, but who reviewed it, what their comments were and who approved the changes;
- Detailed auditing logs provide a complete audit trail of all users’ activities and system events for reporting and audit purposes;
- All document updates and approvals requiring an electronic signature are re-authenticated;
- User IDs can only be logged in from a single location at a time;
- Approval hierarchies can be established for document changes and updates;
- Software upgrades will not modify configuration parameters or settings on the existing system;
- All comments and annotations made to a document are identified by user and time;
- Access control lists allow security permissions to be established for the read, write, and delete of documents, preventing users with write permission from deleting archived documents;
- Automatic workstation logoff ensures inactive sessions require revalidation through authentication system to continue working;
- All security, permission or access changes are audited;
- All documents, workflows, permissions, etc. are stored in an enterprise database with documented schema allowing independent access, backup/restore, reporting, and administration.
