During a regulatory inspection, inspectors expect to find documentedStandard Operating Procedures (SOPs)governing the use, validation, and maintenance ofcomputerized systems, includingdata backup and recovery procedures.
According to theGCDMP (Chapter: Computerized Systems and Compliance)andFDA 21 CFR Part 11, organizations must maintain an SOP that ensuresdata protection against loss, corruption, or unauthorized access. The SOP should describe backup frequency, secure storage, verification of backup integrity, and procedures for data restoration.
While theData Management Plan (A)andEdit Specifications (D)are study-level documents, and theStatistical Analysis Plan (C)focuses on analysis procedures,only a Data Backup Plan (B)constitutes a requiredsystem-level SOPensuring compliance and data continuity.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Computerized Systems and Compliance, Section 5.2 – Data Security, Backup, and Recovery SOPs
FDA 21 CFR Part 11 – Subpart B, Controls for Closed Systems
ICH E6(R2) GCP, Section 5.5.3 – System Security, Data Backup, and Recovery Requirements
