Cleaning, preparation and usage log of equipment, instruments and facilities used in a GMP environment is critical information in any manufacturing environment. Maintaining an equipment logbook is not an option, but it is a mandatory requirements as per FDA 21 CFR 211.182 Equipment cleaning and use log requirements: ‘A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed’.
A paper-based equipment logbook is inefficient and creates a compliance issue. Recording a logbook entry requires at least 2 people to be physically present. Signature requirements from 2 people for every data entry in the logbook reduce productivity and introduce the potential for errors or inaccurate information. Reviewing historical equipment logs requires shifting through stacks of papers and binders. There is a real possibility of missing or inaccurate logs. A paper-based equipment log management process does not support the continuous monitoring process required as per the new process validation guidance.
Through ValGenesis users are able to capture cleaning, preparation and usage logs electronically. Captured logs can be verified and reviewed through controlled workflows available in the system. The system allows end users to design equipment log forms and associated labels as per approved SOPs. Any type of form and label can be created for there is no restriction to the number of created log forms or labels.
- Complete visibility for the cleaning, preparation and usage logs along with real-time validation status for equipment, instruments and facilities.
- Enforce the steps for log recording, verifying and reviewing equipment logs as per the approved SOPs and standards.
- Access to data happens in real time. “Gowning up” or searching through stacks of paper are things of the past.
- Automatic notification to ensure that equipment logs are up to date and have been verified and reviewed on time.
- Logbooks will not be lost or misplaced. They are always available with a real-time status in electronic format.
- Reporting and trending can easily be achieved through ad-hoc reports.
- The system supports a continuous monitoring process during production.