Make 21 CFR Part 11 compliance easier to navigate
21 CFR Part 11 defines the controls required to ensure the integrity, security, traceability and reliability of electronic records and signatures in regulated life sciences environments. But translating regulatory clauses into practical system controls can be complex. Our 21 CFR Part 11 Feature-to-Standard Mapping Guidebook makes it easier by connecting each requirement to the corresponding BPA Medical capabilities, from access control and version management to audit trails, electronic signatures and record retention. Built on Microsoft SharePoint, BPA Medical helps Quality, Compliance, IT and Regulatory teams implement these controls within a familiar, secure quality management environment.
Want to understand exactly how BPA Medical supports 21 CFR Part 11 compliance? Download the guidebook to explore a practical clause-by-clause mapping that explains what each requirement means, which BPA Medical features address it, and what controls organizations should consider when implementing a compliant electronic records environment. Download the guidebook and turn 21 CFR Part 11 from a regulatory requirement into a clear, actionable compliance roadmap.
Discover how BPAMedical365 supports traceability, accountability and data integrity.
21 CFR Part 11 Audit trails are critical for demonstrating who did what, when and why. In BPAMedical365, audit trail capability is implemented and validated as follows:
Time-stamped event logging
For each document (or record) the system captures create-date, modify-date, version history, user ID, and nature of change (edit, comment, check-in/out, approve, reject).
Signature event capture
When an electronic signature (or approval) is executed in a workflow, the system logs the signer’s ID, timestamp, signature meaning (approved, reviewed), and links that to the record version.
Immutable log storage
Audit trail entries cannot be modified or deleted by normal users; administrative or privileged users may only perform log archival or purging under controlled procedure (and such actions are themselves logged).
Version history
Document versioning ensures previous versions are retained; each version is linked to who made the change, when, and why (via metadata or workflow fields).
Workflow transition history
The history of document state changes (e.g., draft → review → approved → released) is logged in the workflow audit log.
Log retention aligned with document retention
The audit log entries are retained at least as long as the underlying document record (or longer if required) and are accessible for review.
Search and reporting
QA or compliance personnel can query audit trails (by user, date, document type, event type) to support internal audits or regulatory inspection.
System check-in/out events
The system logs check-in, check-out, deletion attempts, restore events, and other repository management activities.
Review of audit logs
Our clients conduct regular scheduled reviews of audit logs are defined in QA policy (e.g., monthly review of high-risk document types for unauthorized edits), with findings documented.
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