Maps to
FDA QMSR (Part 820): §820.35
ISO 13485: ISO 13485 §4.2.5
Requirement text
Records required by the QMS shall be controlled. A documented procedure shall define controls for identification, storage, protection, retrieval, retention time, and disposition.
Atomic constraints
- •Record retention policy must be documented
- •Retention periods must be defined
- •Records must be retrievable
- •UDI must be included in complaint and service records where applicable
Evidence signals
- •
FILE_EXISTS
(Record.*Retention|Record.*Control|Record.*Management)
- •
CONTENT_MATCH
Does this document describe record retention policies, retrieval procedures, or UDI requirements in records?
Audit defense
Record control for our QMS is defined in [your document ID]. Retention periods are specified for each record type, records are retrievable within defined timeframes, and UDI is included in complaint and service records as required by QMSR 820.35.