2.
3 Document Control
Purpose:
The purpose of the Document Control process at MARS CRO is to establish a comprehensive system for
managing quality-related documents. This process ensures that all relevant documents, including
policies, procedures, guidelines, and forms, are controlled, reviewed, approved, and readily accessible to
personnel who require them. Effective document control helps maintain consistency, accuracy, and
compliance with regulatory requirements and industry best practices.
Procedure:
1. Document Identification and Version Control:
- All quality-related documents, including policies, procedures, guidelines, and forms, should be clearly
identified with a unique document title, number, and revision date.
- A version control system should be implemented to manage document revisions. Each document
should have a clear version number or identifier, indicating the current revision.
2. Document Creation and Review:
- Documents should be created following standardized templates, formats, and styles to ensure
consistency and readability.
- Document authors should ensure that the content accurately reflects the intended purpose and
aligns with regulatory requirements and best practices.
- Documents should undergo a review process involving relevant stakeholders, subject matter experts,
and the Quality Assurance (QA) department.
- Reviewers should provide feedback on clarity, accuracy, completeness, and compliance with
regulatory requirements.
3. Document Approval:
- The QA department should be responsible for approving documents before they are implemented.
- Document authors should address any feedback or comments received during the review process
and make necessary revisions.
- Once the document meets the required standards and is deemed compliant, it should be approved
by the designated individual or authority within the QA department.
4. Document Distribution and Access:
- Approved documents should be distributed to relevant personnel through a controlled distribution
list or electronic document management system.
- Access to documents should be restricted to authorized personnel who require them to perform their
duties.
- Documents should be made easily accessible and searchable to facilitate efficient retrieval and
reference.
5. Document Revision and Obsolescence:
- Any changes to documents should follow a defined change control process, including proper
documentation, impact assessment, and approval.
- Obsolete documents should be promptly identified and removed from circulation to prevent their
inadvertent use.
- The revision history of each document should be maintained, indicating the changes made, the
reasons for the changes, and the individuals involved.
Actionable Items:
1. Establish a Document Control Policy:
- Develop a policy that outlines the requirements and procedures for document control at MARS CRO.
- Specify roles and responsibilities for document creation, review, approval, distribution, and
obsolescence.
2. Implement a Document Management System:
- Select and implement a document management system that enables efficient control, storage,
retrieval, and version control of quality-related documents.
- Ensure that the system supports document tracking, access controls, and audit trails.
3. Develop Document Templates and Standards:
- Create standardized document templates and formats to ensure consistency and clarity across all
quality-related documents.
- Define clear guidelines for document structure, content, and style.
4. Establish Document Review and Approval Process:
- Define a clear process for document review, involving relevant stakeholders and subject matter
experts.
- Implement a mechanism for capturing and addressing reviewer feedback and obtaining final approval
from the QA department.
5. Establish Document Distribution and Access Controls:
- Develop a controlled distribution list or implement an electronic document management system to
ensure that documents are distributed only to authorized personnel.
- Define access controls and permissions to restrict document access to individuals with relevant
responsibilities.
6. Define Document Change Control Process:
- Establish a change control process that outlines the steps for document revision, including
documentation, impact assessment, and approval.
- Ensure that all changes to documents are properly recorded, and obsolete documents are promptly
removed from circulation.
7.
Conduct Document Training and Awareness:
- Provide training to personnel on the document control process, including the proper use, retrieval,
and revision of quality-related documents.
- Foster awareness among employees regarding the importance of document control in maintaining
quality and compliance.
By implementing an effective Document Control process, MARS CRO ensures the availability, accuracy,
and compliance of quality-related documents, thereby supporting consistent and reliable clinical
research practices.
