21 CFR Part 11 Compliance

Knowing the regulations

Labman can help ensure that your software is 21 CFR Part 11 compliant. The regulation is designed to ensure that electronic records submitted to the FDA for review or approval are reliable, trustworthy and untamperable equivalents to paper records. Electronic records can be accessed and altered without leaving physical traces. These regulations ensure that digitally submitted records followed strict protocols to ensure they cannot be easily falsified or altered.

FDA Requirements

user-permissions

User Permissions

A record of user permissions and an audit trail for every document within a company’s vault. The system should be able to unequivocally identify all people with access to a document, and when and by whom any document was edited or changed.
electronic signatures

Electronic Signatures

Unamendable electronic signatures linked to their corresponding electronic records that include name, date, time of signing and meaning of signature.
documentation

Document Approval

Removal of the possibility of falsification of a document approval, i.e. any approval given must be clearly and unreputedly traceable back to the approver.
Labmax

Training

Compulsory and traceable training and competency for users using any electronic system.
back-up

Secure Back-up

A reliable and secure back-up of data that includes all electronic signatures and required meta data intact.
documentation

Documented System

Clear and change-tracked documentation of the method of operation of the data/document management system itself.