FDA 21 CFR Part 11 Electronic Records & Signatures Compliance
FDA Title 21 CFR Part 11 validation guide with cryptographic digital signatures, dual-custody verification, and audit trails.
FDA Title 21 CFR Part 11 Electronic Records & Electronic Signatures
Designed specifically for clinical diagnostic laboratories, bioanalytical research organizations, and molecular pathology facilities operating under United States FDA regulatory oversight. AILS enforces electronic records authenticity, integrity, and non-repudiation.
System validation, operational sequencing checks, role authority checks, and device checking to ensure record authenticity.
Every signed record includes the printed signer name, UTC date/timestamp, and the explicit clinical meaning (Review, Approval, Release).
Electronic signatures are cryptographically bound to the respective patient PDF report using RSA-256 to prevent copying or tampering.
Electronic signatures require distinct identification codes and passwords or biometric/smart-card credentials ensuring non-repudiation.
Computerized System Validation (CSV)
AILS provides standard Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation documentation packages to streamline FDA auditor inspections.
Immutable Audit Trail Generation
Any modification to an existing test parameter, reference range, or patient result automatically records the previous value, new value, reason for change, and approving pathologist ID without overwriting original records.
Have Specific Laboratory Accreditation Questions?
Our biomedical engineering and compliance specialists can review your laboratory SOPs and assist with LIMS validation checklists.