21 CFR Part 11 Flashcards
What does 21 CFR Part 11 offer
FDA’s thinking on electronic records and signatures
When is a record considered to be electronic?
When an electronic format is used in place of a paper format.
What is 21 CFR 11 applicable to?
-Records maintained in an electronic format in place of a paper format
-Records that are maintained in electronic format and paper format and are relied on to perform regulated activities
-records submitted to FDA in electronic format
-electronic signatures intended to the the equivalent of handwritten signatures
What additional validation for 21 CFR 11 require for electronic records?
None, but it suggests you examine your systems
What is the main purpose of 21 CFR 11?
To ensure that electronic records and electronic signatures are trustworthy, reliable, and equivalent to paper records with handwritten signatures. The regulations ensure electronic records and signatures are authentic and users can’t later claim that the signature wasn’t theirs.
What do you need for audit trails?
Persons must still comply with all applicable predicate rule requirements related to documentation of, for example, date time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries.
controls needed for a closed system?
1) validation of systems
2) ability to create accurate and complete copies
3) records can be readily and accurately retrieved
4) only authorized individuals
5) audit trails record date/time and changes to electronic records that do not obscure previous entries
6) operational system checks
7) authority checks to make sure only authorized users are able to access
8) device checks to determine validity
9) people are properly trained
10) individuals are accountable for their signatures
11) appropriate controls over system
controls needed for an open system?
Same as closed, and additional measures such as document encryption
What information do you need with an electronic signature?
printed name of signer, date/time of signature, meaning associated with signature (review, approval etc)
General requirements of an electronic signature?
each is unique to individual, organization verifies identity of individual, electronic signature is the legal equivalent of a paper signature
Electronic signatures not based on biometrics need:
-two identification components (like ID number and password)
-be only used by genuine owners
-if not used by genuine owner needs to require collaboration of two or more individuals
