followed.

IT/Systems Team: Responsible for ensuring that electronic data systems are secure, validated, and compliant with regulatory requirements, including backup and retrieval procedures for electronic data.

4. Accountability

The QC Manager is accountable for ensuring that data integrity is maintained in all QC documentation. The QA Manager is responsible for reviewing and ensuring that data integrity standards are met and compliance is maintained. The IT/Systems Team is responsible for the security and validation of electronic data systems.

5. Procedure

5.1 Data Entry and Recording

1. Ensure that all test results, calibration data, and equipment performance data are accurately recorded in the appropriate forms, logbooks, or electronic systems.
2. For manual entries, use clear and legible handwriting. For electronic records, ensure that the data is input correctly and consistently. Avoid using abbreviations that may lead to confusion.
3. Ensure that all entries are made in real-time as the test is being performed, and do not leave blank spaces on forms. If there is a need to add information later, draw a single line through the space, and record the additional information with the current date and signature.

5.2 Correction of Errors

1. If an error is found in the documentation, it should be corrected immediately in accordance with established procedures. The incorrect entry should be crossed out with a single line (not erased or obliterated), and the corrected information should be entered next to it with the date, time, and signature of the person making the correction.
2. In electronic records, ensure that changes are tracked using the system’s audit trail feature, with a reason for the change noted and authorized by the appropriate personnel.
3. Ensure that all corrections comply with Good Documentation Practices (GDP) and that all changes are transparent and traceable to ensure data integrity.

5.3 Data Security and Storage

1. Ensure that all data, both paper-based and electronic, is securely stored and protected from unauthorized access. Paper records should be stored in locked cabinets or rooms, and electronic data should be stored in validated systems with password protection and access control.
2. Ensure that all data is backed up regularly, with both on-site and off-site backup options available for critical data. Backup systems should be tested periodically to ensure that data can be restored as needed.
3. For electronic data, ensure that the data management system has features such as data encryption, automatic logging of changes, and secure audit trails to preserve data integrity and meet regulatory requirements.

5.4 Data Retention and Retrieval

1. Ensure that all QC documentation is retained for the required duration according to regulatory and internal policies (typically a minimum of two years or as per regulatory requirements).
2. Ensure that documents are readily retrievable in the event of an audit or inspection. This includes maintaining organized filing systems for paper records and ensuring electronic data is stored in easily accessible formats.
3. Perform periodic reviews to ensure that the data retention and retrieval systems are working as intended and that records are not lost or damaged over time.

5.5 Audit and Review of Data Integrity

1. Conduct regular internal audits to assess compliance with data integrity standards and identify potential weaknesses in the data documentation process. Document the audit results and take corrective actions where necessary.
2. The QA team should review the results of these audits, along with the relevant documentation, to ensure that the data integrity standards are being adhered to across the organization.

5.6 Documentation and Record-Keeping

1. Ensure that all records related to data integrity (e.g., audit logs, data correction logs, backup records) are complete, accurate, and securely stored in compliance with regulatory and internal requirements.
2. Ensure that data entry, correction, storage, and retrieval procedures are regularly reviewed and updated to remain compliant with current regulations and best practices.
3. Maintain a log of any deviations from data integrity protocols and the corrective actions taken to resolve them. Document these deviations in the Deviation Log (Annexure-1).

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• GDP: Good Documentation Practices

7. Documents

1. Annexure-1: Deviation Log
2. Annexure-2: Data Integrity Audit Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Data Integrity and Compliance with CGMP

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Log

Deviation Date	Deviation Description	Corrective Action Taken	Operator
21/01/2026	Missing entry in data log	Corrected and re-entered data in system	John Doe

Annexure-2: Data Integrity Audit Log

Audit Date	Audit Findings	Corrective Action Taken	Audit By
21/01/2026	No discrepancies found	None	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head