FDA’s Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, section 211.182 Equipment Cleaning and Use Log outlines the FDA’s minimum requirements for Logbook Management.
Under 211.182, every piece of equipment including cleanrooms and other controlled work areas, require an individual logbook containing a written record of the date, time, product, and lot number of each batch processed via that equipment or workspace. An additional log containing a record for all major equipment cleaning, maintenance, calibration, and usage of equipment must also be maintained.
In a best-practice environment, log users should log all equipment states, events and conditions no matter how minor so that a logbook does not only comply, but also adds value as a comprehensive diagnostic tool, in the event of equipment fault or failure.
Manual (paper-based) logbook management can threaten even basic quality compliance and cause operational inefficiency as:
- Paper based logbooks offer minimal data integrity assurance and are susceptible to error, damage or loss.
- Legibility, and attribution cannot be assured in a paper-based logbook.
- Requirement to maintain concurrent individual and overall logbooks, present an ongoing risk of duplication or inconsistency between logbook data.
- Physical logbooks risk contamination to cleanroom workspaces during review, replacement, and audit.
- Scheduled and ad-hoc document storage, retrieval and routing pose significant cost and efficiency constraints.
Kneat Gx | Electronic Logbooks (eLogbook)
Unlike other solutions, Kneat’s Electronic Logbook feature, eLogbook, is included in all Kneat Gx versions, with no additional software or hardware purchases, installation or qualification required. Simply setup the electronic logbook work process in your Kneat Gx application and start logging.
A built-in feature of the Kneat Gx platform, eLogbook is quick to setup and can be completed by a Kneat Process Engineer, Partner or a trained ‘Power User’, within your organization.
Kneat Gx eLogbook Features
- Author logbook forms based on approved standard operating procedures (SOP)
- Real-time equipment and cleaning data and report status from any place
- 21 CFR Part 11/EudraLex Annex 11 compliant
- Attach and retrieve supporting documentation in a click
- Easy integration with all other Kneat Work Processes
- Comprehensive, time-stamped, author-attributed logbook history
- Enforced GDP compliance
- Review by exception
Why use Kneat Gx for Electronic Logbook Management?
- eLogbook included in all Kneat Gx versions, with no additional software or hardware purchase, installation or qualification required
- Reduces human error from all related logbook documentation
- Enforces GDP compliance
- Logbook entries can be reviewed in real time from any place
- Eliminates all physical logbook document management, storage, retrieval time loss and costs
- Eliminates all physical logbook loss, damage, and contamination risks
- Enhanced compliance for logbook data integrity (ALCOA)
- Easy integration with other work processes in Kneat
- All of your systems lifecycle documentation, in one easy to use application
Client Story: A Risk-Focused Global Biotech
Transforming Traceability: From Prohibitive to Productive Risk Mitigation
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