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.
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