Build all of the ERES requirements into your Requirements Specification template. Include appropriate subsections: Open Systems, Closed Systems Audit Trails; Nonbiometric Signatures, Biometric Signatures and Procedural. Populate the template with every possible ERES requirement. Simply determine if that system must adhere to 21 CFR Part 11, and which subsections (groups of requirements) are applicable.
A Comprehensive white paper related to 21 cfr part 11 eres requirements in which the system comply with global electronic records and electronic signature requirements to ensure their authenticity and integrity, including audit trail functionality that independently and automatically records a user’s actions when creating, modifying or deleting records. The audit trail must be secure computer generated, must not overwrite changes (preserving the before and after values) and must be human readable, printable and available for inspection.