A temperature file does not become a regulated electronic record merely because it is digital. First identify its purpose and governing regime.
Establish scope
| Question | Record |
|---|
Which country and regulator? | Jurisdiction |
Which product or activity? | Record context |
Does the file replace an official record? | System purpose |
Which procedure requires retention? | Retention basis |
Read 21 CFR Part 11 narrowly
FDA guidance ties scope to records kept/submitted under FDA requirements, interprets it narrowly and notes enforcement discretion for some provisions.
Match the product, activity and record definition with quality or regulatory staff.
Test controls in the system
Keep the raw export in a read-only location and analyse a separate copy.
In a controlled test, see whether a user without permission can change the file.
If corrected, check that old and new values, user, time and reason remain traceable.
Compare the device clock with a reference clock and record the check.
Have a second user export the file and test that raw data match the resulting report.
Paper signatures and retention
If paper records are permitted, confirm dating, signatures and legible correction procedures under the applicable rule.
Moving to an electronic system alone does not prove compliance; procedures, access, backups and training also need review.
Do not infer a specific retention period from shelf life; check the text that applies to the product, market and activity.
Define the retention period in a procedure with an owner, archive location and restore test.
Trying to open an old record can expose file-format, access and backup failures.
Do not generalise one regime's record requirements across medicines and food.
If scope is unclear, record the compliance owner's decision and rationale.
A US Part 11 reference does not automatically impose a legal duty on businesses outside the United States.
