What It Is

FDA 21 CFR Part 11 is a US federal regulation establishing criteria for electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to FDA-regulated industries using electronic systems for predicate rule records, employing a risk-based approach with enforcement discretion on certain elements like validation and audit trails.

Key Components

• **Subpart BControls for closed (§11.10) and open (§11.30) systems, including access limits, audit trails, checks, and signatures.
• **Subpart CElectronic signature requirements for uniqueness, manifestation (§11.50), linking (§11.70), and controls (§§11.100-11.300).
• Core principles: authenticity, integrity, non-repudiation; no fixed number of controls but enforced via SOPs, training, documentation.
• Compliance via risk-based validation, not certification.

Why Organizations Use It

Ensures regulatory acceptance of digital records, mitigates enforcement risks like warning letters, supports data integrity for quality decisions, enables paperless operations, builds inspector trust.

Implementation Overview

Phased: scope predicate records, classify systems, CSV (IQ/OQ/PQ), implement controls, train, monitor. Targets life sciences firms; requires SOPs, audits, no formal certification but FDA inspection readiness.

What It Is

ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a certifiable framework for organizations in the medical device lifecycle, emphasizing risk-based controls to ensure consistent safety, performance, and regulatory compliance across design, production, distribution, servicing, and post-market activities.

Key Components

• Organized into **Clauses 4–8QMS foundation, management responsibility, resources, product realization, measurement/improvement.
• Over 100 requirements focused on documentation, validation, traceability, and post-market surveillance.
• Built on process approach, integrating ISO 14971 risk management; requires certification via accredited bodies with staged audits.

Why Organizations Use It

• Enables market access (EU MDR, FDA QMSR alignment by 2026), reduces recalls, and lowers cost of quality.
• Meets regulatory expectations, builds stakeholder trust, and provides competitive edge in supply chains.

Implementation Overview

• Phased approach: gap analysis, documentation, training, validation, audits.
• Suited for manufacturers, suppliers, SMEs to globals; certification via Stage 1/2 audits, surveillance. (178 words)