including SOPs, protocols, specifications, master records, change controls, deviations, audit reports, CAPA reports, and validation documents maintained in the document management system (DMS) or shared network drives.

3. Responsibilities

• QA Documentation Officer: Uploads, maintains, archives, and retrieves documents as per access rights.
• QA Manager: Reviews, approves, and authorizes document release and access rights.
• IT Administrator: Ensures secure storage, backup, and protection of electronic documentation systems.

4. Accountability

The Head of Quality Assurance is accountable for enforcing document control procedures and ensuring system compliance with regulatory data integrity expectations such as ALCOA+ principles.

5. Procedure

5.1 Classification of Electronic QA Documents

1. Electronic QA documents shall be categorized as:
   • Controlled: SOPs, Master Manufacturing Records, Specifications, Protocols
   • Uncontrolled: Drafts, Logs, Working Notes
   • Archived: Obsolete versions retained for reference

5.2 Document Numbering and Versioning

1. Each electronic document shall be assigned a unique document number as per the Document Numbering SOP.
2. Version numbers shall follow the format: V1.0, V2.0, V3.0, etc.
3. Every change shall be supported by a Document Change Request (Annexure-1) and undergo QA approval.

5.3 Document Review and Approval

1. All electronic documents shall be reviewed by concerned functional heads and approved by QA prior to release.
2. Use the Electronic Document Approval Log (Annexure-2) to track approvals.
3. Electronic signatures used must be password-protected and traceable (with audit trail).

5.4 Access Control and User Rights

1. QA shall define user roles in the Access Control Matrix (Annexure-3) with rights such as View, Edit, Approve, Archive.
2. Only QA-authorized personnel can upload or modify controlled documents.
3. All accesses must be logged and periodically reviewed by QA and IT jointly.

5.5 Storage, Backup, and Security

1. Electronic documents shall be stored on a validated Document Management System (DMS) or secure network with:
   • Audit trails enabled
   • Restricted folder permissions
   • Automatic backups (daily incremental, weekly full)
2. IT must ensure redundancy through off-site or cloud-based backup as per company policy.

5.6 Archival and Retrieval

1. Obsolete versions of documents shall be archived in a dedicated electronic “Archived Docs” directory with read-only access.
2. Documents shall be retained for at least 5 years or as defined by regulatory guidelines.
3. Retrieval shall be logged in the Electronic Document Retrieval Log (Annexure-4).

5.7 Periodic Review and Audit

1. QA shall perform semi-annual audits of the document control system using the QA Document Audit Checklist (Annexure-5).
2. Deviations in document integrity, access violations, or unauthorized edits shall be logged and escalated.

6. Abbreviations

• QA: Quality Assurance
• DMS: Document Management System
• IT: Information Technology
• SOP: Standard Operating Procedure
• GDP: Good Documentation Practice
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, and Available

7. Documents

1. Document Change Request Form (Annexure-1)
2. Electronic Document Approval Log (Annexure-2)
3. Access Control Matrix (Annexure-3)
4. Electronic Document Retrieval Log (Annexure-4)
5. QA Document Audit Checklist (Annexure-5)

8. References

• 21 CFR Part 11 – Electronic Records; Electronic Signatures
• ICH Q7 – Section 6 and 11
• MHRA and WHO Data Integrity Guidelines
• EU GMP Annex 11 – Computerized Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Document Change Request Form

Document Title	Document No.	Change Summary	Initiated By	Date
SOP for Sampling	SOP/API/110/2025	Updated sampling frequency	Sunita Reddy	10/04/2025

Annexure-2: Electronic Document Approval Log

Document No.	Version	Approved By	Date
SOP/API/110/2025	V2.0	QA Head	12/04/2025

Annexure-3: Access Control Matrix

User Role	View	Edit	Approve	Archive
QA Officer	Yes	Yes	No	No
QA Manager	Yes	Yes	Yes	Yes
IT Admin	Yes	No	No	Yes

Annexure-4: Electronic Document Retrieval Log

Date	Document No.	Retrieved By	Purpose	Authorized By
13/04/2025	SOP/API/050/2023	Rajesh Kumar	Audit Reference	QA Manager

Annexure-5: QA Document Audit Checklist

Audit Point	Compliant (Y/N)	Remarks
Document versions traceable	Yes	Controlled via DMS
Unauthorized access detected	No	Access rights valid

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Version	New SOP Creation	QA Head
14/04/2025	2.0	Expanded to include DMS, audit trails, and backup security	Compliance Enhancement	QA Head