FDA 21 CFR Part 11

Title 21 CFR Part 11 establishes the conditions under which the FDA considers electronic records and electronic signatures to be equivalent to paper records and handwritten signatures. Any system used in FDA-regulated activities — clinical trial management, drug manufacturing, medical device development — must comply with Part 11 if it creates, modifies, maintains, archives, retrieves, or transmits records required by FDA regulations.

Part 11 compliance requires a validated system — meaning the system has been formally validated through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to demonstrate it consistently produces results meeting specifications. Computer System Validation (CSV) is the process through which this is demonstrated, and it must be documented in a way that would survive FDA inspection.

The intersection of Part 11 with modern cloud-based software requires careful architecture. Cloud SaaS systems used in clinical contexts must demonstrate that the vendor's infrastructure provides the audit trail, access controls, and data integrity controls required by Part 11. IaaS deployments require the customer to implement these controls. Most clinical software teams do not architect for this distinction — resulting in systems that fail validation.

We architect FDA 21 CFR Part 11 compliance into clinical and pharmaceutical software systems from the first design decision — building audit trails, electronic signature workflows, and access controls that generate validation-ready documentation as a byproduct of normal operation. Our teams have experience with Computer System Validation processes and can support IQ/OQ/PQ documentation.

Compliance-Native Architecture Guide

Design principles and a structured checklist for building software that is compliant by default — not compliant by retrofit. Covers data architecture, access controls, audit trails, and vendor due diligence.