21 CFR Part 11 and electronic records
The US requirement for electronic records and signatures. Relevant if you export to the US or work for a US parent company.
What is 21 CFR Part 11?
21 CFR Part 11 is the FDA's rule on when an electronic record and an electronic signature can replace paper and a handwritten signature. The rule applies to companies regulated by the FDA, which typically means those selling to the US market.
The requirements fall into three groups. The record must be accurate and complete and available for inspection throughout the retention period. The system must have access control and an audit trail that records who did what and when, without it being possible to overwrite it. And electronic signatures must be uniquely linked to one person and must not be transferable.
For a monitoring system, this means in practice that measurements, alarms and acknowledgements must be timestamped, unaltered and linked to named users.
Whether your overall setup meets Part 11 is assessed during validation, which we carry out together with you. The system supports the requirements.
What Part 11 requires
Unaltered records
It must not be possible to change or delete data without leaving a trace in the audit trail.
Available for the whole period
Records must be readable and printable for as long as they need to be retained.
Access control
Only authorised users have access, and access is linked to named individuals.
Timestamped audit trail
Who did what and when, recorded automatically and with no way to overwrite it.
Unique signatures
An electronic signature is linked to one person and cannot be transferred or reused.
System controls
There must be control over who can change the configuration, and changes must be logged.
When is Part 11 relevant for you?
The rule applies to companies under FDA oversight. If you only sell in the EU, Annex 11 is the relevant set of rules. If you export to the US or are part of a US group, Part 11 comes on top. Many companies choose to meet both, because the requirements are similar in practice, but the assessment must be made by your QA.
Frequently asked questions
Is OCEAView 21 CFR Part 11 compliant?
The system supports electronic records and signatures. Whether your overall setup meets the requirement is decided during validation, which we carry out.
Does Part 11 apply to us if we only sell in Denmark?
No, not in itself. Then EU GMP Annex 11 is what applies. If you are part of a US group, there may still be internal requirements.
What is the difference between Annex 11 and Part 11?
Annex 11 is European and covers computerised systems broadly. Part 11 is American and focuses on electronic records and signatures.
What is ALCOA?
The principles of data integrity: data must be attributable to a person, legible, contemporaneous, original and accurate. Both Annex 11 and Part 11 are built on them.
Should every user have their own account?
Yes. Shared accounts make it impossible to attribute an action to a person, and then the audit trail does not hold up.
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