FDA 21 CFR Compliance
What is FDA 21 CFR?
FDA 21 CFR Part 11 establishes requirements for electronic records and electronic signatures (ERES) used by organizations regulated by the U.S. Food and Drug Administration. It helps ensure that electronic records are trustworthy, reliable, secure, and equivalent to their paper-based counterparts.
Key Requirements Under FDA 21 CFR
Compliance requires controls across electronic records, signatures (ERES), access, and system activity, including:
Electronic Records
Records must remain accurate, reliable, and protected from unauthorized changes.
Electronic Signatures
Signatures must be securely linked to the signed record and attributable to the individual.
Audit Trails
System activity and changes must be recorded in a traceable, time-stamped audit trail.
Access Controls
User access must be restricted based on roles and authorization.
System Validation
Systems must be validated to ensure they consistently perform as intended.
Record Retention
Electronic records must remain accessible and protected throughout the required retention period.
Why FDA 21 CFR Compliance Matters
For pharmaceutical, healthcare, life sciences, and other regulated organizations, non-compliant electronic processes can increase audit risk, documentation errors, and operational complexity. Part 11-aligned controls help organizations protect data integrity, demonstrate accountability, and maintain reliable records throughout the document lifecycle.
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How MSB Docs Supports FDA 21 CFR Compliance
MSB Docs provides compliance-focused controls that help organizations manage electronic records and signatures within secure digital workflows.
Role Access
Helps control who can view, create, approve, or e-sign records.
Audit Logs
Provide visibility into document and workflow activity.
Electronic Signatures
Support attributable and traceable approvals.
Encrypted Storage
Helps protect electronic records from unauthorized access.
Document Integrity Controls
Help maintain reliable records throughout their lifecycle.
Validated Systems
Support consistent and controlled digital processes.
With these controls, MSB Docs replaces fragmented paper-based processes with secure digital workflows while improving traceability, operational efficiency, and audit preparedness.
Build secure, compliant digital workflows with MSB Docs.