Standard Operating Procedure for Document Control

1) Purpose

The purpose of this SOP is to establish procedures for the control, distribution, revision, and archiving of documents to ensure accuracy, accessibility, and compliance with regulatory requirements within the organization.

2) Scope

This SOP applies to all departments and functions within the organization that create, review, approve, distribute, and maintain documents as part of the quality management system.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Document Control Manager:

Responsible for overseeing the document control system and procedures.

3.2 Quality Assurance (QA) Specialist:

Responsible for reviewing and approving controlled documents and managing document changes.

3.3 Department Heads:

Responsible for ensuring departmental compliance with document control procedures and requirements.

4) Procedure

4.1 Document Creation and Approval:

4.1.1 Create documents using approved templates and formats.
4.1.2 Obtain necessary approvals (e.g., author, reviewer, approver) as per document control procedures.
4.1.3 Assign a unique document number and version control for identification.

4.2 Document Distribution:

4.2.1 Distribute approved documents to relevant departments or individuals.
4.2.2 Ensure controlled copies are accessible only to authorized personnel.
4.2.3 Maintain a distribution log to track document dissemination.

4.3 Document Revision and Change Control:

4.3.1 Initiate document changes through the Change Request Form.
4.3.2 Review and approve document changes by designated personnel.
4.3.3 Update document version and notify affected parties of changes.

4.4 Document Retrieval and Archiving:

4.4.1 Establish document retrieval procedures to ensure timely access to current documents.
4.4.2 Archive obsolete or superseded documents in accordance with document retention policies.
4.4.3 Maintain document archives and ensure availability for regulatory inspections and audits.

4.5 Document Control Review and Improvement:

4.5.1 Conduct periodic reviews of document control procedures and effectiveness.
4.5.2 Implement improvements to document control processes based on review findings and feedback.
4.5.3 Provide training to personnel on updated document control procedures as necessary.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Document Control Procedures Manual
2. Document Templates
3. Change Request Form
4. Distribution Log
5. Document Archive Inventory

7) Reference, if any

1. ISO 9001:2015 Quality management systems – Requirements
2. FDA Guidance for Industry: Document Control

8) SOP Version

Version 1.0