21 CFR Part 11

FDA Electronic Records and Electronic Signatures

FDA requirement for electronic records and signatures in clinical trials, R&D, and pharmaceutical manufacturing environments.

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Applies to

Life Sciences & Healthcare

Value Proposition: Why Choose AdVran for 21 CFR Part 11?

FDA-regulated organizations using electronic records and signatures must demonstrate that their systems are validated, secure, and maintain data integrity throughout the record lifecycle.

1. System Validation Support

We maintain the IT infrastructure underlying validated systems in a qualified state—documented configurations, change controls, and operational procedures that support your validation protocols.

2. Access Controls and Audit Trails

Part 11 requires unique user identification, secure authentication, and computer-generated, timestamped audit trails. We implement and monitor these controls across all regulated systems.

3. Electronic Signature Controls

We ensure electronic signature systems meet Part 11 requirements—binding signatures to records, preventing repudiation, and maintaining signature/record integrity throughout retention periods.

4. Data Integrity (ALCOA+)

Our infrastructure controls support the ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. Data integrity is built into system operations, not retrofitted.

5. Change Control for Regulated Systems

Every change to systems in Part 11 scope follows a validated change control process with impact assessment, testing documentation, and approval workflows—satisfying both FDA expectations and good IT practice.

Frequently asked questions

FDA 21 CFR Part 11 compliance

What is FDA 21 CFR Part 11 and who needs to comply? +

FDA requirement for electronic records and signatures in clinical trials, R&D, and pharmaceutical manufacturing environments.

How does AdVran help with FDA 21 CFR Part 11 compliance? +

AdVran provides end-to-end FDA 21 CFR Part 11 compliance management, including gap assessment, control implementation, continuous monitoring, evidence collection, and audit coordination. Our team handles the technical complexity so you can focus on your business.

How long does it take to achieve FDA 21 CFR Part 11 compliance? +

Timeline depends on your current security posture and the scope of required controls. Most organizations achieve initial compliance within 3-6 months with AdVran's guidance. We provide a detailed timeline during our initial assessment.

What happens if we fail a compliance audit? +

AdVran conducts pre-audit readiness assessments to identify and resolve gaps before the official audit. If issues are found during an audit, we provide immediate remediation support and work with auditors to address findings.

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