In 21 CFR Part 820.40, the FDA details its document control requirements for medical device companies. Medical device manufacturers are responsible for establishing and maintaining procedures to control all documents outlined in 21 CFR Part 820, including product and supplier controls, design control documentation, CAPA, and standard operating procedures (SOPs).
A document control plan is a document created by a medical device company which outlines how the company will approve documents, make them available for use wherever needed, remove them from circulation whenever obsolete and
The FDA's document control requirements help to ensure that documents in the quality system have undergone an adequate approval process. Medical device companies must designate an individual to review and approve all documents that are subject to the requirements of 21 CFR Part 820. In addition, all document approvals must also include a date and a signature.
Document controls help to ensure that staff members or manufacturing operators for medical device companies can access the most current and up-to-date specifications and safety information. Approved documents in the QMS must be made available at all locations where they are needed, and obsolete documents should be immediately removed from circulation wherever they are used.
Medical device companies are also responsible for keeping track of how documents are changed over time. Change records should include a description of the change, which document was changed, signatures, the date when the change was made and the effective date of the change. When a document is changed, it should be re-approved by the same individual within the function or organization that originally approved the document.
A document control plan satisfies the requirement that medical device companies have to establish and maintain document control procedures. It describes how the medical device company will organize itself to meet the requirements of 21 CFR Part 820.40. A typical document control plan includes the following:
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