What It Is

FDA 21 CFR Part 11 is a U.S. 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. The risk-based approach narrows scope to relied-upon electronic records, with enforcement discretion for validation, audit trails, retention, and copies per 2003 guidance.

Key Components

• **Subpart BControls for closed (§11.10) and open (§11.30) systems, including validation, audit trails, access limits, checks, signatures manifestation/linking.
• **Subpart CElectronic signature requirements (§§11.50-11.300) for uniqueness, multi-component controls, non-repudiation.
• Core principles: authenticity, integrity, confidentiality, accountability. No fixed control count; focuses on 11+ key controls like training, policies.
• Compliance via self-assessment, FDA inspection; no third-party certification.

Why Organizations Use It

Mandated for life sciences using electronic records; ensures data integrity for inspections, avoids warning letters. Benefits: inspection readiness, quality decisions, efficiency. Builds trust, reduces recalls, supports digital transformation.

Implementation Overview

Risk-based: scope records, classify systems, validate (CSV/IQ/OQ/PQ), implement controls, train, SOPs. Applies to pharma, devices, biotech; phased (6-24+ months). FDA audits via inspections.

What It Is

23 NYCRR Part 500 is the New York Department of Financial Services (NYDFS) Cybersecurity Regulation, a prescriptive state-level mandate for financial services entities. It establishes minimum risk-based cybersecurity requirements to protect nonpublic information (NPI) and ensure operational integrity, applying to Covered Entities like banks, insurers, and mortgage firms licensed in New York.

Key Components

• 14 core requirements including cybersecurity program, CISO governance, MFA, encryption, TPSP oversight, penetration testing, and 72-hour incident reporting.
• Risk-based approach with annual assessments, dual CEO/CISO certification by April 15, and five-year record retention.
• Enhanced rules for Class A Companies (e.g., >$20M NY revenue, >2,000 employees) like independent audits and EDR.

Why Organizations Use It

• Mandatory compliance avoids multimillion-dollar fines (e.g., Robinhood $30M).
• Reduces cyber risk, improves resilience, and builds stakeholder trust.
• Aligns with enterprise risk management for competitive edge.

Implementation Overview

• Phased roadmap: gap analysis, asset inventory, MFA rollout, TPSP contracts, testing.
• Applies to NY-licensed financial entities; no certification but annual filing and DFS examinations.