FDA QSR Document Controls

Information & Training. | Medical Devices

Documentation is key to demonstrating compliance with the quality system regulations. Documentation acts as a record of all activities previously performed, documentation also controls ongoing activities via approved, released procedures.

The QSR’s require that all activities under the control of the manufacturer, which potentially impact product quality shall be documented, signed off as approved and released for use. Documents must be approved by competent individuals, who understand the potential device quality impact of the procedure. The approval of documentation needs to go through a defined (and itself approved) change control process. This change control process will require that release of a document requires review by competent individuals that represent the potentially impacted functions and that these individuals signoff the document to indicate their agreement. The signoff may be via hand written signature and date, or may be via electronic signature, provided the electronic signature is in accordance with the FDA electronic signature requirements. Where a document is changed, then at a minimum, the same functions that approved the original document need to agree to the change proposed. There needs to be a full description of the reason for making a change to an approved document, along with back-up evidence supporting the change, e.g. validation reports, customer feedback data, yield data, etc..

Documents need to be released and distributed as necessary, with any obsolete revisions of documents removed from use. Staff, supplier, distributors, clinicians need to be trained on the requirements of relevant procedures and full records maintained of such training.



Subpart D – Document Controls
Sec. 820.40 FDA QSR Document controls.
Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:
(a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.
(b) Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.

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