(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.

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.

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

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