Part 11 Scope & Applicability Assessment

Part 11 Scope and Applicability Assessment. The organization shall conduct and maintain a documented assessment to determine which systems, records, and signatures fall within the scope of 21 CFR Part 11, in accordance with the FDA Guidance for Industry "Scope and Application" (September 2003). The assessment shall evaluate: (a) all computerized systems used to create, modify, maintain, archive, retrieve, or transmit records required by FDA predicate rules (e.g., 21 CFR Parts 210, 211, 820, 606, 111, or other applicable regulations); (b) whether the records maintained by each system are required by a predicate rule or are submitted to the FDA; (c) whether electronic signatures are used in lieu of handwritten signatures to meet predicate rule signature requirements; (d) the risk classification of each system based on the potential impact on product quality, patient safety, and data integrity; and (e) the determination of whether each system operates as a closed system or an open system. For each system determined to be within scope, the organization shall document the applicable predicate rule(s), the types of electronic records maintained, whether electronic signatures are employed, and the risk-based controls applied. This assessment shall be reviewed and updated whenever new systems are introduced, existing systems undergo significant changes, or applicable regulatory requirements change. A system inventory shall be maintained listing all Part 11-applicable systems, their validation status, and their compliance disposition.