SOP Guide for Pharma

BA-BE Studies: SOP for Backup and Archiving of Analytical Data – V 2.0

Auditor

BA-BE Studies: SOP for Backup and Archiving of Analytical Data – V 2.0

Standard Operating Procedure for Backup and Archiving of Analytical Data in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/186/2025
Supersedes SOP/BA-BE/186/2022
Page No. Page 1 of 9
Issue Date 17/04/2025
Effective Date 20/04/2025
Review Date 17/04/2026

1. Purpose

To define the procedure for systematic backup and long-term archiving of analytical data generated in bioavailability and bioequivalence (BA/BE) studies, ensuring data protection, recovery readiness, and regulatory compliance.

2. Scope

This SOP applies to all electronic and paper-based analytical data generated in bioanalytical laboratories performing BA/BE studies, including data from LC-MS/MS systems, chromatography data systems (CDS), Laboratory Information Management Systems

(LIMS), and associated documents.

3. Responsibilities

  • Analyst: Ensures data is saved correctly in designated folders or servers after run completion.
  • IT Administrator: Manages daily, weekly, and monthly backups of servers, validates restoration functionality, and ensures security.
  • QA Personnel: Reviews archive inventory, verifies backup logs, and oversees periodic audit readiness checks.
  • Archiving Officer: Responsible for physical storage, indexing, and retrieval of paper-based records.
See also  BA-BE Studies: SOP for Gowning Procedures for Clinical Staff - V 2.0

4. Accountability

The Head of Bioanalytical Operations is accountable for ensuring implementation of this SOP to safeguard all data generated in support of BA/BE study submissions.

5. Procedure

5.1 Electronic Data Backup

  1. All data must be saved immediately after run completion to the secure central server in a pre-defined study-specific folder.
  2. Daily backups shall be scheduled through automated backup software.
  3. Types of backup:
    • Full Backup: Performed weekly on Sundays
    • Incremental Backup: Performed daily for newly added or changed files
    • Monthly Archive Backup: Stored offsite in secure storage
  4. Backup logs must be maintained in Annexure-1: Electronic Backup Log Sheet.

5.2 Backup Validation

  1. Every quarter, QA shall select one study and validate the recovery of backup files.
  2. Restored data shall be verified against original data to confirm completeness and integrity.
  3. Document recovery check results in Annexure-2: Backup Recovery Test Log.

5.3 Archiving of Paper-Based Records

  1. Original records (e.g., sample logbooks, calibration printouts, raw data) shall be:
    • Indexed, labeled, and compiled in study-wise record folders
    • Stored in fire-resistant, locked archival rooms with restricted access
  2. Maintain record of archived folders in Annexure-3: Archive Inventory Register.
  3. Assign a unique Archive ID to each folder for easy retrieval.
See also  BA-BE Studies: SOP for Clinical Trial Facility Cleaning and Hygiene - V 2.0

5.4 Data Retention and Access

  1. All BA/BE study data shall be retained for a minimum of 5 years or as specified by the regulatory authority.
  2. Data retrieval requests must be made in writing and logged in Annexure-4: Archive Access Log.
  3. Only authorized personnel may retrieve archived records under supervision.

5.5 Data Security and Disaster Recovery

  1. All backup devices must be encrypted and stored in a secure environment.
  2. In case of disaster (fire, hardware failure), follow the IT Disaster Recovery Plan to restore data from last successful backup.
  3. QA shall initiate an incident report and document data restoration performance.

6. Abbreviations

  • BA/BE: Bioavailability/Bioequivalence
  • LIMS: Laboratory Information Management System
  • CDS: Chromatography Data System
  • QA: Quality Assurance

7. Documents

  1. Electronic Backup Log Sheet – Annexure-1
  2. Backup Recovery Test Log – Annexure-2
  3. Archive Inventory Register – Annexure-3
  4. Archive Access Log – Annexure-4

See also  BA-BE Studies: SOP for Setting Up eTMF (Electronic Trial Master File) - V 2.0

8. References

  • 21 CFR Part 11 – Electronic Records; Electronic Signatures
  • MHRA Guidance on GxP Data Integrity
  • ICH Q9: Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Electronic Backup Log Sheet

Date Backup Type Backup Path Status Performed By
16/04/2025 Incremental \serverdataBAE-094 Successful IT Admin

Annexure-2: Backup Recovery Test Log

Date Study ID Files Restored Verification Status Verified By
01/04/2025 BAE-088 Complete Matched QA Officer

Annexure-3: Archive Inventory Register

Archive ID Study ID Date Archived Location Archived By
ARCH-0201 BAE-082 12/04/2025 Shelf B-2 Sunita Reddy

Annexure-4: Archive Access Log

Request Date Requested By Archive ID Purpose Returned On Authorized By
15/04/2025 Dr. Anil Mehta ARCH-0201 Regulatory Audit 16/04/2025 QA Head

Revision History:

Revision Date Revision No. Details Reason Approved By
01/01/2022 1.0 Initial SOP Release New SOP QA Head
17/04/2025 2.0 Inclusion of Annexures and Cloud Backup Provisions Audit Recommendation QA Head
Exit mobile version