cleaning validation processes. It includes review of electronic and manual records by designated personnel prior to batch release.

3. Responsibilities

• QC/Production Personnel: Generate and record raw data as per applicable SOPs.
• Section Head (QC/Production): Performs initial data verification and correction (if any) with justification.
• QA Department: Performs cross-verification of raw data against primary documents, test reports, and logs.

4. Accountability

The Head of Quality Assurance is accountable for ensuring raw data review and verification are conducted systematically to maintain data integrity across the organization.

5. Procedure

5.1 Definition of Raw Data

1. Raw data refers to original records or certified copies containing actual observations and results of activities performed, including:
   • Instrument printouts (e.g., HPLC chromatograms, FTIR spectra)
   • Logbooks and worksheets
   • Electronic files (audit trailed)
   • Calibration records and cleaning logs

5.2 Documentation Requirements

1. All raw data must be:
   • Legible, dated, and signed
   • Recorded in permanent ink (for manual data)
   • Free from overwriting; corrections must be signed and justified
2. Electronic data must be stored on validated systems with secure access and audit trails.

5.3 Review of Raw Data (Manual and Electronic)

1. QA or designated reviewer shall:
   • Verify test results match reported values in CoA and summary sheets
   • Check that all required entries are made and signed
   • Confirm traceability of sample ID, batch number, and analytical method
   • Review instrument-generated data against analytical worksheets
2. Discrepancies, missing data, or unexplained deviations shall be addressed using a Raw Data Discrepancy Form (Annexure-1).

5.4 Cross-Verification of QC Data

1. Verify the following:
   • System suitability test results
   • Integration parameters and peak areas
   • Retention time and resolution
   • Result calculation and dilution factors
   • Reference standard usage logs
2. Cross-check electronic data entries (e.g., in LIMS) with hard copies and audit trails.

5.5 Cross-Verification of Production Data

1. Review BMR entries:
   • Yield calculations
   • Material dispensing log against issued quantity
   • Equipment usage and cleaning records
   • Process parameters vs. defined limits
2. Compare batch numbers, labels, and logbook entries for consistency.

5.6 Handling and Documentation of Discrepancies

1. If any discrepancies or gaps are found:
   • Record in Raw Data Discrepancy Log (Annexure-2)
   • Investigate and justify corrections, if acceptable
   • For critical errors, raise a deviation report and inform QA Head

5.7 Approval and Archival

1. Once reviewed, QA shall sign the reviewed data pages or verification sheet and archive all reviewed raw data.
2. Store original data in a secure location with controlled access. Electronic data must be archived as per data retention SOP.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis
• BMR: Batch Manufacturing Record
• FTIR: Fourier Transform Infrared Spectroscopy
• LIMS: Laboratory Information Management System
• SOP: Standard Operating Procedure

7. Documents

1. Raw Data Discrepancy Form (Annexure-1)
2. Raw Data Discrepancy Log (Annexure-2)
3. Review and Verification Checklist (Annexure-3)

8. References

• ICH Q7 – Section 6: Documentation
• 21 CFR Part 211.194 – Laboratory Records
• MHRA Data Integrity Guidance
• ALCOA+ Principles of 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 Discrepancy Form

Date	Reference No.	Description of Discrepancy	Action Taken	Reviewed By
12/04/2025	QC/2025/032	Missing signature on FTIR report	Signed post-verification	Sunita Reddy

Annexure-2: Raw Data Discrepancy Log

Sr. No.	Date	Area	Nature of Discrepancy	Deviation No. (if any)
001	10/04/2025	QC	Incorrect calculation in assay report	DEV/2025/04

Annexure-3: Review and Verification Checklist

Parameter	Checked (Yes/No)	Remarks
Data complete and legible	Yes	All pages reviewed
Entries signed and dated	Yes	Compliant
Audit trail checked	Yes	No irregularities found

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New SOP	QA Head
14/04/2025	2.0	Integrated electronic audit trail review steps	Data Integrity Enhancement	QA Head