CFR 21-820.40a - 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.

Attention points

• Each document should have an owner for approval
• Document should be available to stakeholders. Distribution of documents should be controlled.
• Obsolete documents should be removed to prvenet unintended use!