During a regulatory inspection, inspectors expect to find documented Standard Operating Procedures (SOPs) governing the use, validation, and maintenance of computerized systems, including data backup and recovery procedures.
According to the GCDMP (Chapter: Computerized Systems and Compliance) and FDA 21 CFR Part 11, organizations must maintain an SOP that ensures data 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 the Data Management Plan (A) and Edit Specifications (D) are study-level documents, and the Statistical Analysis Plan (C) focuses on analysis procedures, only a Data Backup Plan (B) constitutes a required system-level SOP ensuring 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