sequence files, and audit trails.

3. Responsibilities

• Analyst: Ensures accurate generation, naming, and storage of data files post-run.
• Reviewer/Supervisor: Verifies completeness and correctness of data folders and sequence files.
• QA: Conducts audits and reviews the archival and access control systems for raw data.
• IT Administrator: Manages secure backups and controls access permissions.

4. Accountability

The Head of Bioanalytical Department is accountable for ensuring the traceability, completeness, and secure archival of raw data in compliance with GxP regulations and data integrity requirements.

5. Procedure

5.1 Raw Data File Types and Sources

1. Raw data includes:
   • Sequence files (.seq, .wiff, .raw)
   • Chromatogram data
   • Instrument logs
   • Audit trails and processing methods
2. Data may be stored locally on instrument systems or transferred to central servers.

5.2 File Naming and Folder Structure

1. Use the following naming convention for folders:
   • Format: [StudyCode]/[Analyte]/[BatchID]/[YYYY-MM-DD]
   • Example: BE1245/Metformin/Batch03/2025-04-17
2. Ensure each folder contains:
   • Sequence file
   • Raw chromatograms
   • Integration results
   • System suitability test results

5.3 Data Transfer and Backup

1. Upon completion of run, transfer data to the central secured server within 24 hours.
2. Data must be backed up to:
   • Primary storage (lab server)
   • Secondary offsite/cloud backup
3. Use checksum or hash validation to confirm data integrity post-transfer.

5.4 Data Access and Security

1. Restrict access to raw data to authorized personnel only via password-protected directories.
2. Maintain access logs indicating user ID, login time, and files accessed.
3. QA shall periodically review access logs and highlight anomalies.

5.5 Data Review and Locking

1. Once raw data is reviewed and approved, mark the folder as “locked” and move to read-only format.
2. Any post-lock changes must be tracked via Change Control procedures.
3. Review of peak integration, audit trails, and system suitability must be completed before approval.

5.6 Archival and Retrieval

1. Raw data files must be archived:
   • Digitally on secure servers for at least 5 years or as per regulatory requirements
   • Maintain a copy on archival media (DVD, secure drive)
2. Archive location must be recorded in Annexure-1: Raw Data Archival Log.
3. Retrievals for inspection must be documented using Annexure-2: Data Access Request Form.

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• GxP: Good Practice (GLP/GCP/GMP)
• SOP: Standard Operating Procedure
• QA: Quality Assurance

7. Documents

1. Raw Data Archival Log – Annexure-1
2. Data Access Request Form – Annexure-2

8. References

• ICH E6(R2): Good Clinical Practice
• 21 CFR Part 11 – Electronic Records and Signatures
• FDA Guidance on Data Integrity

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Data Archival Log

Study Code	Batch ID	Folder Path	Archival Date	Archived By
BE1245	Batch03	\ServerBA1245Batch03	17/04/2025	Sunita Reddy

Annexure-2: Data Access Request Form

Date	User Name	Data Requested	Purpose	Authorized By
18/04/2025	Rajesh Kumar	BE1245 Batch03	Internal Audit	QA Manager

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP	New process	QA Head
17/04/2025	2.0	Included backup verification and access log review	Regulatory update	QA Head