Document Control Checklist

Document Control Checklist

Certainly, here’s a Document Control Checklist tailored for the life science industries, which includes pharmaceuticals, biotechnology, medical devices, and healthcare:

Document Identification:

– Assign a unique document identifier, such as a document number or code.

– Clearly state the document’s purpose and scope.

– Indicate the document’s version, issue date, and effective date.

Regulatory Compliance:

– Ensure that documents adhere to relevant industry regulations (e.g., FDA regulations, ISO standards).

– Cross-reference regulatory requirements within the document, when applicable.

Review and Approval:

– Specify roles responsible for document review and approval (e.g., subject matter experts, regulatory personnel).

– Document review and approval dates with appropriate signatures.

Validation and Qualification:

– For software or equipment-related documents, outline validation or qualification requirements.

– Document validation and qualification activities, outcomes, and responsible parties.

Standard Operating Procedures (SOPs):

– Clearly define procedures and processes using standardized templates.

– Specify the frequency of SOP- Standard Operating Procedures review and update.

Quality Control and Assurance:

– Define quality control measures for documents, including accuracy and data integrity checks.

– Establish procedures for addressing discrepancies or errors found during quality control checks.

Change Control:

– Document the change control process for modifying or updating documents.

–  Describe how changes are proposed, evaluated, approved, and implemented.

Document Format:

– Use standardized formats for different document types (e.g., protocols, batch records, patient records).

– Ensure consistency in font, font size, headings, and formatting elements.

Version Control:

– Implement a clear version control system to track document revisions.

– Outline how to identify the latest version and its corresponding changes.

Data Integrity:

– Address Data Integrity principles, especially when dealing with electronic records and signatures.

– Describe how to maintain the integrity of data throughout the document lifecycle.

Training and Competency:

– Document training requirements for individuals using or handling documents.

– Maintain records of training completion and competencies.

Archiving and Retention:

– Specify retention periods for different document types based on regulatory requirements.

– Define archiving procedures for documents that have reached the end of their retention period.

Document Lifecycle:

– Detail the stages of the document lifecycle (creation, review, approval, distribution, updates, archiving).

– Define responsibilities at each stage clearly.

Electronic Signatures:

– If applicable, outline procedures for electronic signatures in compliance with regulations (e.g., 21 CFR Part 11).

Audits and Inspections:

– Prepare for regulatory audits and inspections by ensuring all required documents are organized and accessible.

– Keep a record of past audits and their outcomes.

Continual Improvement:

– Regularly review and update the document control process based on feedback and lessons learned.

– Implement improvements to enhance efficiency, accuracy, and compliance.

Remember, this checklist serves as a starting point. Adapt and customize it according to the specific needs, regulations, and practices of your organization within the life science industries.


ISO 9001 Document Control Checklist | Compliance Group

ISO 9001 Quality Management System | QMS | Compliance Group

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