FDA 21 CFR Part 11 Assessment
IQ, OQ & PQ Services (GMP/GDP)
Readiness assessment for FDA 21 CFR Part 11 electronic records and signatures requirements. Includes gap analysis against audit trail, data integrity, and electronic signature requirements with formal compliance documentation.
FDA Part 11 Compliance Gap Assessment
Companies supplying the US market or operating under FDA jurisdiction must ensure that electronic monitoring records and any associated electronic signatures meet the specific technical and procedural controls defined in 21 CFR Part 11 — a requirement that is frequently misunderstood or only partially implemented. An undetected gap in audit trail completeness or data integrity protection can render electronic monitoring records inadmissible during FDA inspections. Seemoto's assessment identifies exactly which Part 11 requirements your current monitoring setup satisfies and what corrective actions are needed.
How it's deployed
Assessment is delivered remotely or on-site and covers the Seemoto platform configuration as deployed in your environment: user role and permission settings, audit trail capture scope, record export integrity controls, and time-stamp synchronization. The output distinguishes between gaps in the software configuration, gaps in SOPs, and gaps in training documentation — so remediation effort is accurately scoped.
Evidence & Reporting
The deliverable is a formal FDA 21 CFR Part 11 Gap Analysis Report mapping each assessed requirement to a compliance status (compliant, gap, not applicable) with supporting evidence references and recommended corrective actions prioritized by regulatory risk. A Compliance Summary matrix suitable for inclusion in regulatory submissions or inspection preparation packages is included. Where all identified gaps are remediated, Seemoto can issue a supplemental Compliance Attestation.
Included and Optional Capabilities
Included
- Validation Master Plan
Complete validation planning documentation
- IQ/OQ/PQ Protocols & Reports
Full protocol and report packages
- Risk Assessments
Comprehensive risk analysis
Optional add-ons
- On-site Audit Support
Expert support during audits
- Annual Revalidation
Yearly revalidation services
Related IQ, OQ & PQ Services (GMP/GDP) Offerings
Frequently Asked Questions
Part 11 applies to any electronic records created, modified, maintained, archived, retrieved, or transmitted under FDA regulations — this includes temperature monitoring logs used to support batch release, complaints, or deviation investigations, regardless of whether electronic signatures are applied. Electronic signatures are subject to additional requirements, but the audit trail, access control, and data integrity controls in §11.10 apply broadly.
Yes — the gap analysis report includes prioritized remediation recommendations, and Seemoto can implement configuration changes to the monitoring platform (such as enabling additional audit trail fields or tightening user permission structures) as a follow-on activity. For procedural gaps in SOPs or training, Seemoto provides template documents and guidance.
The FDA 21 CFR Part 11 assessment is specifically scoped to electronic records and signature controls under US federal regulations and does not cover the equipment qualification activities (IQ/OQ/PQ) required under GMP or GDP frameworks. The two activities are complementary: qualification demonstrates the system measures correctly, while the Part 11 assessment demonstrates that the resulting records are legally admissible under FDA rules.
Plan FDA 21 CFR Part 11 Assessment
Talk with Seemoto about the sensor, gateway, reporting, and compliance setup for fda 21 cfr part 11 assessment.