21 CFR Part 11

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.