If your lab has purchased the Compliance Pack, the super administrator can activate it in the modules of your choice (see section 5.1 for more information).

Once enabled, the Compliance Pack allows LabCollector to support 21 CFR Part 11 and GxP compliance by providing the following features:

  • Record locking, to prevent unauthorized modifications.
  • Electronic signatures, to formally approve records.

To make changes, navigate to: Preferences > Reasons.


In this tab, you define the list of options used as reasons when editing or signing records, as well as when modifying lots in the Reagents & Supplies module and maintenance entries in the Equipment module.

After activation, record versioning is automatically enabled.

  • Every change to a record requires the user to provide a reason for the modification, creating a complete audit trail.

 


After a user archives a record with the read-only option, they will have the option to sign the records. To signs a record, they must select or enter a reason for the signature. This reason becomes part of the record history and ensures full traceability.

  • Any reason entered when signing a record is now included in printed and exported records, further strengthening audit compliance.


Note
  • These features help ensure regulatory compliance by making all actions on records traceable and justified.
  • Users cannot bypass the reason requirement; providing a reason is mandatory when signing or modifying a record.