Log management is one of the most essential elements of a quality management system. Documenting and maintaining equipment usage and cleaning logs with required audit trails is a mandatory requirement as per FDA 21 CFR 211.182, as well as in the spirit of FDA 21 CFR Part 11 and EMA Annex 11. Manual paper-based equipment logbooks may be inaccurate, leading to non-conformances due to manually entered data, with the possibility of missing or non-contemporaneously signed veriﬁcations of entries performed, as well as multiple business inefﬁciencies that lead to deviations, observations and time losses. Manual documentation of equipment and clean room logs is time consuming and reduces the productivity of operators and supervisors, while increasing the probability of an error. In addition, paper logs are typically not centrally located or available electronically, so the review of historical equipment log data may require searching through stacks and stacks of paper records. Obviously, those searches are not value-added activities for skilled resources and could be detrimental during inspections when every minute matters.
The ValGenesis eLog is an enterprise class validated software system that compliments plant ﬂoor automation by managing and tracking equipment use, cleaning status, maintenance and calibration records with an easy to use mobile app that supports commonly used mobile devices such as iPad and Android. Users can capture logs through mobile devices by simply scanning the QR code available at the equipment, instruments and/or clean rooms, with or without network connectivity. The logs are captured with automatic date, time, product and lot number for each batch processed. This helps users to easily schedule, assign, track and report all equipment information required for regulatory compliance and forms a strong foundation for both asset management strategy and continued monitoring programs.
Features of ValGenesis eLog
- Many types of log management programs can be created and managed in ValGenesis eLog, including equipment logs and clean room logs, etc.
- End users can design log forms as per their approved SOPs with or without the formulas for automated calculations to avoid human errors.
- Many types of workﬂows can be deﬁned at the log type and asset levels.
- Quick access to the real-time status of any GxP asset at the site level and across the organization.
- Verify equipment status in real-time to ensure equipment/rooms are only used when in the proper state.
- System dynamically calculates equipment clean and dirty hold times, based on the drug product and equipment, as per the approved cleaning validation protocols.
- Schedule routine process operations including calibration, preventive maintenance and cleaning etc.
Beneﬁts of ValGenesis eLog:
- Eliminates paper-based logbooks and binders that can be lost or misplaced.
- Reporting and trending are easily achieved, with all relevant data stored electronically in the database.
- Ensures integrity of data contained in electronic logbooks, with all data captured “direct to database” (required for compliant operation).
- Assures correct ﬁrst-time data capturing that dramatically improves regulatory compliance.
- Verify and review log entries through controlled workﬂows.
- Facilitates compliance with FDA 21 CFR 211.182 and is in the spirit of 21 CFR Part 11 and EMA Annex 11.
- Deﬁne and verify clean and dirty hold times per approved cleaning validation protocols.
- Schedule system alerts and reminders for upcoming due dates for various tasks.
- Decrease or eliminate the risk of using incorrect or out of service equipment.
- Establish equipment veriﬁable usage traceability.
- Completely remove the risk of human error in documentation of equipment usage and cleaning log management operations with automated/validated calculations and reports.