OpsTrakker GMP Solutions
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Enable Real-Time Visibility with OpsTrakker Digital Logbook Software
Paper-based equipment use-logs come with baggage. Many logs are not completed appropriately and may create GMP compliance issues. From operational and compliance perspectives, maintaining detailed logbooks that clearly identify all equipment activities and recordings is essential. For immediate access to equipment data for analytics, visualization, and continuous improvement, a digital solution is essential.
Use Case Examples
- Equipment Cleaning Logs
- Room Cleaning Logs
- Shift Handover Logs
- Maintenance Logs
- Daily Weight Check Logs
- And many more...
A robust and effective electronic equipment use-log must:
- Enable real-time data capture and equipment status management
- Have the end user at its core and support simple, guided entry for users of all capabilities
- Allow specific users to quickly view and analyze logbook data regardless of location or proximity
- Compliance with requirements for electronic records and signatures
- Enable data reporting and visualization to promote process improvement
OpsTrakker eLogBook Software
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OpsTrakker’s eLogBook solution is specifically designed to eliminate paper use-logs and logbooks in GMP manufacturing facilities, to enhance manufacturing capabilities. With 25+ years in the industry, our knowledge and expertise has allowed us to create an digital logbook solution that is easy to implement, user-friendly and compliant with federal regulations. OpsTrakker eLogBook enables highly configurable records for all equipment types and activities, including usage, cleaning, calibration, maintenance, and more.
Electronic Logbook Management
OpsTrakker’s online logbook solution provides easy access to data and statistical reports. The lean solution can be deployed in a matter of month’s to assist in your digitalization goals. The solution supports multi-plant scaling to promote standardization and harmonization across the enterprise. Logs inside the module can be accessed by all authorized personnel, anytime from anywhere, using a supported browser or mobile device.
Solution Features
- Review by exception functionality
- Parameterization for form flexibility and reuse
- Biometric Authentication with Nymi Band
- Real-time visibility of all assets including status and attributes
- 1D/2D Barcode and QR Code Supported Entry
- FDA Compliant Electronic Signatures
- Seamless integration with ERP and historians
- Enhanced security
- Enforced field completion
- Mobile first approach
- FDA 21 CFR Part 11 compliant software
Problems Solved
- Incomplete or inaccurate data input related to paper-based systems
- Lost or misplaced physical logbooks
- Illegible completion of use-logs
- Incorrect calculations
- High cost and inefficiencies associated with storing paper-based logbooks
- Inability to perform trend analysis or provide any beneficial data without time and human resources
- Bulky to store and not easily retrievable
- Relabeling throughout production
Benefits Delivered
- Improved operator efficiency
- Mobile Support for iOS, Android, and PCs
- Equipment data capture
- Review by Exception Out of the Box
- Promote sustainability goals by eliminating paper
- Right first time execution
- Audit-ready environment
- FAQ
What is an electronic logbook (eLogbook) for pharmaceutical manufacturing?
What is an electronic logbook (eLogbook) for pharmaceutical manufacturing?
An electronic logbook, or eLogbook, is a digital system used to replace paper logbooks for recording equipment usage, cleaning, maintenance, status changes, and other manufacturing activities. OpsTrakker eLogBook provides electronic logbook functionality designed for GMP pharmaceutical and life sciences manufacturing.
What is GMP electronic logbook software?
What is GMP electronic logbook software?
GMP electronic logbook software digitizes equipment and operational records used in regulated Good Manufacturing Practice environments. OpsTrakker eLogBook enables manufacturers to create controlled electronic records with traceability, electronic signatures, audit trails, and real-time access to equipment information.
How do electronic logbooks replace paper logbooks in pharmaceutical manufacturing?
How do electronic logbooks replace paper logbooks in pharmaceutical manufacturing?
Electronic logbooks replace handwritten entries with structured digital records completed at the point of execution. OpsTrakker eLogBook can digitize equipment use logs, cleaning logs, maintenance records, room cleaning records, shift handovers, daily checks, and other paper-based GMP logbooks.
How do electronic logbooks replace paper logbooks in pharmaceutical manufacturing?
How do electronic logbooks replace paper logbooks in pharmaceutical manufacturing?
Electronic logbooks replace handwritten entries with structured digital records completed at the point of execution. OpsTrakker eLogBook can digitize equipment use logs, cleaning logs, maintenance records, room cleaning records, shift handovers, daily checks, and other paper-based GMP logbooks.
How do electronic logbooks support 21 CFR Part 11 requirements?
How do electronic logbooks support 21 CFR Part 11 requirements?
Electronic logbook systems used in regulated environments can support 21 CFR Part 11 requirements through capabilities such as electronic records, electronic signatures, audit trails, user authentication, access controls, and data integrity. OpsTrakker eLogBook is designed for use in regulated pharmaceutical and life sciences manufacturing environments.
How does an electronic logbook improve data integrity in GMP manufacturing?
How does an electronic logbook improve data integrity in GMP manufacturing?
Electronic logbooks improve data integrity by capturing structured information directly at the point of execution, enforcing required entries, maintaining audit trails, and reducing handwritten records and manual transcription. OpsTrakker eLogBook provides controlled digital records that improve traceability throughout the equipment record lifecycle.
Can electronic logbook software track equipment status in real time?
Can electronic logbook software track equipment status in real time?
Yes. Electronic logbook software can provide current equipment status and activity history without requiring personnel to locate and review a physical logbook. OpsTrakker eLogBook provides real-time visibility into equipment information and associated manufacturing activities.
What is review by exception in electronic manufacturing records?
What is review by exception in electronic manufacturing records?
Review by exception allows reviewers to focus on records containing deviations, missing information, exceptions, or other conditions requiring attention rather than manually reviewing every record with the same level of effort. OpsTrakker supports review-by-exception workflows to help streamline manufacturing record review.
Can electronic logbooks be used for equipment cleaning and room cleaning records?
Can electronic logbooks be used for equipment cleaning and room cleaning records?
Yes. Electronic logbooks can digitize equipment cleaning, room cleaning, sanitation, and other GMP cleaning records. OpsTrakker enables these activities to be executed through controlled digital workflows rather than paper records.
Can electronic logbook software integrate with MES, ERP, LIMS, or other manufacturing systems?
Can electronic logbook software integrate with MES, ERP, LIMS, or other manufacturing systems?
Yes. Electronic logbooks can be integrated with other manufacturing and enterprise systems to connect equipment records with the broader digital manufacturing environment. OpsTrakker is designed to integrate with existing manufacturing technology rather than requiring organizations to replace their entire system landscape.
What is OpsTrakker eLogBook?
What is OpsTrakker eLogBook?
OpsTrakker eLogBook is electronic logbook software for pharmaceutical and life sciences manufacturing. It replaces paper-based equipment and operational logbooks with controlled electronic records, real-time equipment information, digital workflows, and searchable manufacturing history.