This section defines controls required to ensure data is attributable, legible, contemporaneous, original, accurate, and complete, with full compliance to electronic record and signature requirements.
1. Purpose and Scope This article defines how computerized systems achieve and maintain compliance with 21 CFR Part 11. It establishes expectations for electronic records and signatures used in GxP activities and provides a structured checklist and remediation approach to…
1. Purpose and Control Objective Access control and electronic signature controls ensure that only authorized individuals can access computerized systems, perform regulated actions, and approve or verify records in a manner that is attributable, traceable, and secure. These controls protect…
1. Purpose and Scope This article defines the principles of ALCOA and ALCOA+ and establishes how they are implemented as enforceable controls within computerized systems and procedures. It focuses on ensuring that GxP data remains reliable, traceable, and suitable for…
1. Purpose and Control Objective Audit trails and data change controls ensure that all GMP-relevant data creation, modification, and deletion activities are recorded, traceable, and reviewable. These controls establish: They are the primary mechanism for ensuring traceability and detecting unauthorized…
1. Purpose and Scope Backup, restore, and disaster recovery controls ensure that GMP electronic records and supporting systems can be recovered in a complete, accurate, and usable state following data loss, system failure, or catastrophic events. This article addresses: It…
1. Purpose and Scope This article defines how data integrity is governed and how a risk-based approach is used to determine the type and depth of controls applied to computerized systems. It establishes the decision framework that links data criticality…
1. Purpose and Scope Electronic records lifecycle and retention controls ensure that GMP records remain complete, protected, accessible, and readable from creation through final disposition. This article addresses control of: It does not address access control, audit trails, or backup…