Standard Operating Procedure (SOP) for Document Control
1. Purpose:
This SOP provides a comprehensive framework for controlling all documents related to quality
systems, manufacturing processes, and compliance activities in a highly regulated environment.
It ensures that documents are appropriately created, reviewed, approved, distributed, accessed,
revised, and archived to maintain their accuracy, integrity, and confidentiality.
2. Scope:
This procedure applies to all controlled documents, including but not limited to SOPs, policies,
work instructions, forms, reports, and records that are essential for operational processes,
quality assurance, and regulatory compliance.
3. Responsibilities:
Document Control Officer: Oversees the document control system, ensures
compliance with this SOP, and maintains the document registry.
Quality Assurance (QA) Manager: Approves documents for adequacy prior to release
and ensures ongoing compliance with regulatory standards.
Department Heads: Ensure that their departmental documents are current, correctly
implemented, and accessible to authorized personnel.
All Employees: Adhere to the documented procedures and ensure the use of correct
and current documents in their respective roles.
4. Definitions:
Controlled Documents: Documents that are governed by this SOP and are subject to
review, approval, and change control procedures.
Document Life Cycle: The stages a document goes through from creation, review, and
approval to distribution, use, revision, and archiving.
Revision Control: A system for tracking changes to documents and ensuring the most
current version is in use.
5. Procedure:
5.1 Document Creation and Revision:
A. Initiate document creation or revision with a documented request, detailing the
purpose and scope of the document.
B. Draft the document using standardized templates and format. Ensure content is
clear, accurate, and complies with applicable regulations and standards.
C. Review the document internally for technical accuracy and regulatory
compliance.
D. Submit the document for approval via a defined approval hierarchy. Document
the approval in the document control system.
5.2 Document Numbering and Version Control:
A. Assign a unique identification number and version to each document. The
system should capture the document type, creation date, department, and version
number.
B. Ensure version control is maintained, and only the latest approved version is
available for use.
5.3 Document Distribution and Access:
A. Distribute documents through a controlled mechanism that ensures only
approved, current versions are accessible to authorized personnel.
B. Utilize electronic document management systems (EDMS) where possible to
control access, distribution, and versioning.
5.4 Training and Awareness:
A. Inform relevant personnel of new or revised documents. Provide training as
necessary to ensure understanding and implementation of the document contents.
B. Record training and acknowledgment of document receipt and understanding.
5.5 Document Review and Update:
A. Establish a regular review schedule for all controlled documents to ensure they
remain current and applicable.
B. Initiate document updates as processes change or as a result of continuous
improvement initiatives, regulatory updates, or audit findings.
5.6 Document Retention and Archiving:
A. Define retention periods for all document types based on regulatory requirements
and business needs.
B. Securely archive obsolete documents, ensuring they are retained for the required
duration and can be retrieved for reference or audits.
5.7 Audit and Compliance:
A. Conduct regular audits of the document control process to ensure compliance
with this SOP and regulatory requirements.
B. Address audit findings promptly and implement corrective and preventive actions
to mitigate any identified risks.
6. Documentation:
Maintain records of all document control activities, including creation, revisions, approvals,
distribution, training, and archiving, ensuring they are accurate, complete, and audit-ready.
7. Revision History:
Document the history of revisions to this SOP, including the revision number, description of
changes, author, approval, and effective date.
