Module11 May 20264 min read
Module spotlight: long-term archival & retention
Regulators expect you to keep records for years — sometimes decades. Record archival keeps approved records immutable, searchable, and retained to the rules of every market you sell in.
By MoniDoseQMS Team
Quality records do not stop mattering when a project ends. Different markets require manufacturers to retain technical and quality records for many years after a product is placed on the market. Record archival keeps your approved records safe, searchable, and retained for exactly as long as the rules require.
What you can do
- Keep a central, immutable archive of every approved record
- Assign retention periods aligned to MDR, FDA, UK, and Japan rules — 10, 15, 20, or 25 years
- Search the archive and review what you have retained at any time
- Trace every archived record back to its original source and approval
Why it matters
ALCOA+ data integrity expects records to be enduring and available. Multi-market retention, with traceability and immutability built in, means that years later you can still produce the evidence an auditor or authority asks for.