21 CFR Part 11 Compliant LIMS
FDA-compliant electronic records and signatures with complete audit trails for pharmaceutical and medical device laboratories.
Complete 21 CFR Part 11 Coverage
Electronic Signatures (§11.70)
- Cryptographic digital signatures
- User authentication and authorization
- Non-repudiation controls
System Access (§11.300)
- User access control and permissions
- Session management and timeouts
- Failed login attempt monitoring
Audit Trail (§11.10e)
- Secure, timestamped change records
- User identification for all actions
- Data integrity and tamper evidence
Data Integrity (§11.10)
- Data validation and verification
- Backup and recovery procedures
- Protection against data loss
FDA Inspection Ready
Validation Documentation
Complete IQ/OQ/PQ protocols and validation reports included.
Audit Trail Reports
Generate comprehensive audit reports for FDA inspections.
Risk Assessment
Built-in controls address common FDA 483 observations.
Change Control
Managed system updates with validation impact assessment.
Pharmaceutical & Medical Device Testing
Specialized workflows for FDA-regulated industries
Drug Testing
Stability, dissolution, potency
Medical Devices
Biocompatibility, sterility
Clinical Testing
Sample chain of custody
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