Audit Trails
Computer-generated records of every operator action on regulated data — date, time, identity — retained with the record, tamper-protected, and available for FDA inspection.
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What 21 CFR Part 11 Compliance Covers
Part 11 defines the technical and procedural standards electronic systems must meet to be accepted by the FDA as equivalent to paper records and handwritten signatures.
Electronic Signatures
Unique per individual, cryptographically linked to their record, and displaying the signer's full name, timestamp, and meaning — review, approval, or authorship.
System Validation
Systems must be validated through IQ, OQ, and PQ phases with documentation updated whenever changes affect the validated state.
Access Controls
Identity verification and role-based controls limit each user to authorized functions, enforce permitted sequencing, and anchor reliable audit trails.
Record Integrity and Retention
Records must stay accurate and retrievable across multi-decade retention periods. Archive formats and backup procedures are planned from day one.
FDA Predicate Rule Mapping
Part 11 governs electronic systems where a predicate rule requires records. Mapping each rule — GCP, Part 820, CLIA — defines the compliance perimeter and drives validation scope.
How We Implement 21 CFR Part 11 Compliance
From predicate rule mapping to validation documentation — each step produces specific deliverables that determine whether a system will pass FDA inspection.
Why Part 11 Compliance Is a Market Access Requirement
Pharmaceutical companies, contract research organizations, and medical device manufacturers will not deploy software that has not been designed and validated with Part 11 requirements in mind — doing so would jeopardize their own FDA compliance posture. Click through to see what is at stake.
Book a Part 11 Compliance ConsultationMarket Gate
For digital health companies building products for clinical research, medical device quality systems, or regulated laboratory environments, Part 11 compliance is a market access requirement. Regulated customers will not deploy non-compliant systems because doing so creates their own FDA inspection exposure.
Inspections
FDA inspections of pharmaceutical manufacturers and clinical trial sponsors routinely include examination of the computer systems used to generate and maintain regulated records. Audit trail deficiencies and improperly controlled electronic signatures are among the most commonly cited Part 11 findings in FDA warning letters.
Warning Letters
Part 11 deficiencies found during FDA inspection can result in warning letters, import alerts, or clinical hold actions that disrupt the regulated entity's operations. Software vendors whose systems contributed to Part 11 deficiencies face loss of customer relationships and significant reputational damage in the regulated industry.
Built In
Audit trails, electronic signature linkage, and validation documentation are architecture decisions — not features that can be added to an existing system at low cost. Systems designed without Part 11 requirements in mind require significant rework to achieve compliance, and the documentation trail for a retrofitted system is harder to defend.
Validated
System validation is not a one-time event. Any change that affects the system's validated state requires a change control assessment and potentially revalidation. Organizations that treat validation as a project milestone rather than an ongoing program discover this during inspections.
Part 820
Medical device manufacturers operating under 21 CFR Part 820 must meet quality system requirements for design history files, device master records, and corrective action records. When those records are electronic, Part 11 applies. Companies building software for device manufacturers must understand both regulations and how they interact.
The Part 11 Requirements That Drive System Architecture
Each requirement maps to specific software design decisions and validation deliverables — architectural commitments made before development begins. Hover a card to see what each demands.
Audit Trail Requirements
Computer-generated audit trails must capture every action on regulated records — date, time, operator identity, and create/modify/delete events — in tamper-protected storage retained with the record and available for FDA inspection.
Electronic Signature Requirements
Electronic signatures must be unique, non-reusable, and cryptographically linked to the record — displaying full name, date, time, and the meaning of the signature.
Computer System Validation
Systems must be validated through a structured three-phase protocol — IQ, OQ, PQ — with traceability matrices, a Validation Summary Report, and a change control program before generating regulated records.
Access Control Requirements
System access must be limited to authorized individuals with role-appropriate function restrictions — identity verification, unique user IDs, permitted-sequence enforcement, and session management controls.
Record Integrity and Retention
Electronic records must remain accurate, complete, and retrievable across multi-decade retention periods — technology-independent archiving, backup and recovery, format stability, and audit-trail co-retention.
FDA Predicate Rule Scope
Part 11 applies only where a predicate rule requires records — 21 CFR Part 820, GCP, CLIA, GMP, and submission records. Scope definition is the first compliance step.
The Part 11 Compliance Stack We Build With
Validation frameworks, audit logging infrastructure, electronic signature tooling, and regulated cloud environments — selected to match the predicate rule scope and inspection readiness requirements of FDA-regulated software deployments.
G
GAMP 5
I
IQ / OQ / PQ
F
FDA 21 CFR Part 11
F
FDA CSV Guidance
T
Traceability Matrix
I
Immutable Audit Logs
D
DocuSign eSignature
A
AWS CloudTrail
A
Azure Monitor Logs
P
PKI Signature Chain
A
AWS GxP
A
Azure GxP
G
Google Cloud GxP
A
AWS HealthLake
V
Veeva Vault
E
EDC Platforms
L
LIMS Integration
2
21 CFR Part 820
I
ISO 13485
E
eCTD Submissions
FDA Customers Won't Deploy Software Without Part 11 Validation.
We build Part 11 compliance into clinical trial, medical device, and laboratory software — audit trails, electronic signatures, IQ/OQ/PQ validation, and the documentation package FDA inspectors require.
Book a Part 11 Compliance Consultation
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Frequently Asked Questions
[ 1 ]
Does Part 11 apply to all software used in healthcare?
No. Part 11 applies specifically to electronic records that are required to be maintained or submitted to the FDA under an applicable FDA predicate rule, and to electronic signatures used on those records. Clinical trial data management software, medical device quality management systems, laboratory systems used in FDA-regulated research, and manufacturing execution systems in pharmaceutical facilities are common Part 11 environments. Electronic health record systems used in routine clinical care, patient-facing health apps, and other health technology products that do not support FDA-regulated activities are not subject to Part 11, though they may be subject to other regulatory requirements including HIPAA.
[ 2 ]
What is the difference between 21 CFR Part 11 and 21 CFR Part 820?
21 CFR Part 11 governs electronic records and electronic signatures. 21 CFR Part 820, commonly called the Quality System Regulation, governs the quality management requirements for medical device manufacturers. Part 820 requires that medical device manufacturers maintain design history files, device master records, quality records, and complaint files, among others. When those records are maintained electronically, Part 11 applies to the electronic systems used to maintain them. Part 820 is currently being harmonized with ISO 13485, the international medical device quality management standard, through FDA's Quality Management System Regulation update. Digital health companies building software for medical device manufacturers need to understand both regulations and how they interact.
[ 3 ]
What is computer system validation and why is it required under Part 11?
Computer system validation is the documented process of establishing and verifying that a computer system consistently produces a result meeting its predetermined specifications and quality attributes. Part 11 requires that systems used to create, modify, maintain, or transmit regulated records be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Validation follows a structured three-phase methodology: Installation Qualification, Operational Qualification, and Performance Qualification. Each phase produces documented test results that constitute evidence of the system's validated state. Validation documentation must be maintained and updated when the system changes in ways that could affect its validated state.
[ 4 ]
What happens if an FDA inspection finds Part 11 deficiencies in our software?
FDA inspections of pharmaceutical manufacturers and clinical trial sponsors routinely include examination of the computer systems used to generate and maintain regulated records. When Part 11 deficiencies are found — inadequate audit trails, improperly controlled electronic signatures, unvalidated systems, or insufficient access controls — the FDA can issue Form 483 observations, which must be formally responded to. Serious or repeated deficiencies can result in warning letters that are publicly posted, import alerts that block product entry into the US market, or clinical hold actions that halt ongoing clinical trials. For regulated customers, these consequences create strong demand for software that has been designed and validated with Part 11 requirements from the start.
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