21 CFR Part 11 Compliance
FDA requirements for electronic records and electronic signatures. BioWise is designed from the ground up to meet these regulations.
What is 21 CFR Part 11?
21 CFR Part 11 is the FDA regulation that establishes criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
The regulation applies to all FDA-regulated industries including pharmaceuticals, biologics, medical devices, and food manufacturing. It covers any electronic records that are created, modified, maintained, archived, retrieved, or transmitted under FDA requirements.
Key Requirements & How BioWise Complies
§ 11.10(d) - Access Controls
Systems must limit access to authorized individuals and enforce role-based permissions.
BioWise Implementation:
- • Role-based access control (RBAC) with configurable permissions
- • Multi-factor authentication (MFA) support
- • Integration with enterprise identity providers (SSO/SAML)
- • Tenant isolation for multi-organization deployments
§ 11.10(e) - Audit Trails
Systems must create secure, computer-generated, time-stamped audit trails recording operator actions.
BioWise Implementation:
- • Immutable audit logs for all record changes
- • Captures who, what, when, and previous values
- • AI agent actions fully logged with reasoning
- • Export capabilities for regulatory review
§ 11.50-200 - Electronic Signatures
Electronic signatures must be unique, verifiable, and linked to records.
BioWise Implementation:
- • Unique user identification with credential verification
- • Signature manifestations include name, date/time, and meaning
- • Cryptographic binding of signatures to records
- • Support for biometric authentication where required
§ 11.10(c) - Record Authenticity & Integrity
Systems must ensure records are authentic, unaltered, and accurate.
BioWise Implementation:
- • Cryptographic hashing for document integrity verification
- • Version control with complete history
- • No deletion of records—only logical archival
- • Automatic backup and disaster recovery
§ 11.10(a) - System Validation
Systems must be validated to ensure accuracy, reliability, and consistent performance.
BioWise Support:
- • GAMP 5 Category 4 validated software
- • IQ/OQ documentation packages available
- • Risk-based validation approach
- • Pre-validated configuration options
Validation Documentation
Provided by BioWise
- System Description Document
- Functional Specifications
- Installation Qualification (IQ) Protocol
- Operational Qualification (OQ) Protocol
- Traceability Matrix
- Release Notes
Customer Responsibility
- User Requirements Specification
- Performance Qualification (PQ)
- Validation Summary Report
- SOPs for System Use
- Periodic Review Documentation
Ready to learn more about compliance?
See how BioWise helps pharmaceutical companies maintain 21 CFR Part 11 compliance while streamlining operations.
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