To comply with GMP guidelines and 21 CFR Part 11 requirements, pharmaceutical companies need to guarantee the full traceability of critical data and the ability to secure access to this data. According to guidelines, a computerized system should consider electronic records, electronic signatures, and handwritten signatures completed via electronic records to be trustworthy and reliable.
The Life Sciences Weighing and Dispensing module provides the following:
- Out-of-the-box electronic signature requirements for GMP-critical activities, including the execution of instrument calibration and verification tasks.
- Capability to align the electronic signature password with the one set up in the active directory to which the users belong.
- Capability for a second person to check each configured key stage of a dispensing process to ensure that mistakes can be caught and resolved early in the process.
Electronic signature
To comply with 21 CFR Part 11 requirements, the Life Sciences Weighing and Dispensing module offers additional electronic signature requirements for GMP-critical actions, such as the execution of calibration and verification tasks.
This ensures that only authorized users perform critical activities and run controls on documentation. User credentials and the time of the execution are stored and made available for each action performed.
The electronic signature requires the username and password of the user logged in to the system. Comments/notes can be added to include additional information on the operation.
Second person verification
A second user, different from the one executing the operation, is required to enter a username and password to acknowledge the verification of the predefined stage. These second checks are required to assure:
- Changes to sensitive records are made only by authorized personnel.
- Inputs and outputs are checked for accuracy.
The second person verification can be enabled in the Life Sciences Weighing and Dispensing Master for the following events:
- Instrument control closure, in Dispensing setup > Equipment > Scheduled controls > Scheduled activity for instrument > Closure verification checkbox. The second person verification can be enabled for selected instrument control, so it applies only to the control and the instrument for which the control is open.
- Cleaning operation execution, in Dispensing setup > Cleaning types > Details. The second person verification is a property of the cleaning type, so it can be enabled for specific cleaning types based on the business need. Once the checkbox is ticked, a second user is required to run the verification task and sign it electronically.
- Manual data entry, in File > Configuration > Work order > Dispensing parameters > Check accuracy on manual input checkbox.
- Use of an expired sub-batch, in File > Entities > Dispensing order > Dispensing order line > Actions > Confirm use of an expired lot > Right-click on the record > Action properties > Sign checkbox.
- Reject the weighed quantity in File > Entities > Dispensing order > Dispensing order line > Actions > Reject the weighed quantity > Right-click on the record > Action properties > Sign checkbox.
The second person verification, along with the username and password, can require a reason code when enabled.