CFR 21-820.40b - 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.

Attention points

• The FDA expects the following elements in change control:
  • Description of the change
  • Identification f the affected documents
  • Signature of the approving individuals
  • Approval date
  • Effective date of the change
• Document changes should be in control over the following documents:
  • CFR 21-820.30b - Design and development planning
  • CFR 21-820.30c - Design Input
  • CFR 21-820.30d - Design Output
  • CFR 21-820.30e - Design Review
  • CFR 21-820.30e - Design Review
  • CFR 21-820.30f - Design Verification
  • CFR 21-820.30g - Design Validation
  • Approval of the Design Master Record or 820.40
  • Equipment maintenance and inspection activities 820.70g
  • Calibration performance 820.72b
  • Approval of process validation 820.75a
  • Performance of validated processes 820.75b
  • Release of finished devices 820.80d
  • Device acceptance activities performed 820.80e
  • Authoization to use nonconforming products 820.90b
  • Laberling inspection 820