Maps to
FDA QMSR (Part 820): §820.45
ISO 13485: ISO 13485 §7.5.1
Requirement text
Labeling activities shall be controlled. Label accuracy shall be verified before release.
Atomic constraints
- •Labeling procedures must be documented
- •Label accuracy must be verified before release
- •Label storage and control must be defined
- •UDI labeling requirements must be addressed
Evidence signals
- •
FILE_EXISTS
(Label.*Control|Labeling.*SOP|Label.*Verification|Label.*Procedure)
- •
CONTENT_MATCH
Does this document describe labeling control procedures, label verification, or UDI labeling requirements?
Audit defense
Labeling controls for [your product] are managed through [your document ID]. All labels are verified for accuracy before release, label storage and issuance are controlled, and UDI requirements are addressed per QMSR 820.45.