We build Part 11 compliance into clinical trial, medical device quality, and regulated laboratory software — audit trails, electronic signatures, IQ/OQ/PQ validation, and the documentation package that pharmaceutical companies, CROs, and device manufacturers require before deployment.
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Part 11 applies when FDA predicate rules require records to be maintained and those records are maintained electronically. The regulation defines the technical and procedural standards electronic systems must meet to be accepted by the FDA as equivalent to paper records and handwritten signatures.
Computer-generated audit trails documenting the date, time, and identity of operator actions that create, modify, or delete electronic records. Audit trail entries must be retained for at least as long as the records they document, protected against modification by general users, and available for FDA inspection — affecting database design and application architecture from day one.
Electronic signatures must be unique to each individual, never reused or reassigned, and cryptographically linked to their records so they cannot be excised or transferred to falsify a document. Each signature must display the signer's full name, timestamp, and the meaning of the signature — review, approval, or authorship — as Part 11 requires.
Computer systems used for regulated records must be validated to ensure accuracy, reliability, consistent performance, and the ability to detect invalid or altered records. Validation follows a structured methodology — Installation Qualification, Operational Qualification, and Performance Qualification — with documentation maintained and updated whenever the system changes in ways that affect its validated state.
System access must be limited to authorized individuals through identity verification and role-based authority checks. The system must enforce access controls that limit each user to authorized functions and data, and operational checks must enforce permitted sequencing of steps where required. Reliable user identification is the prerequisite for meaningful audit trails.
Electronic records must be accurate, complete, and retrievable throughout their required retention period — often several decades for clinical trial records. Archive strategies must ensure long-term readability as technology changes. Backup procedures protect against data loss, and record formats must be planned from the start with retention duration in mind.
Part 11 does not create new record-keeping requirements — it governs electronic systems when an FDA predicate rule requires records to be kept. Mapping each predicate rule to the electronic systems in scope — Good Clinical Practice records, 21 CFR Part 820 quality records, CLIA laboratory records — defines the compliance perimeter and drives validation scope.
A structured process from predicate rule mapping to validation documentation — each step with specific technical and procedural deliverables that determine whether an electronic system will satisfy FDA inspection and support regulated customers' own compliance posture.
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 ConsultationEach Part 11 requirement maps to specific software design decisions and validation deliverables. These are not configuration choices — they are architectural commitments that must be made before development begins.
Computer-generated audit trails must capture every action on regulated records with identity and timestamp.
Electronic signatures in Part 11 contexts have specific identity, linkage, and display requirements.
Systems must be validated through a structured three-phase protocol before generating regulated records.
System access must be limited to authorized individuals with role-appropriate function restrictions.
Electronic records must remain accurate, complete, and retrievable throughout multi-decade retention periods.
Part 11 applies only where a predicate rule requires records — scope definition is the first compliance step.
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
Audit trails, electronic signature linkage, IQ/OQ/PQ validation, and change control — we build Part 11 compliance into the architecture before development begins and produce the validation documentation package that regulated customers and FDA inspectors expect. Book a consultation and we will scope the compliance requirements for your regulated software environment.
Book a Part 11 Compliance Consultation
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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.
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.
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.
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.
