Frequently Asked Questions
eLogBook, short for electronic logbook software, is an electronic record keeping system for equipment records, use-logs, and status management.
Typically, most equipment records are hand-written, and consume thousands of paper copies each year. 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.
OpsTrakker’s eLogBook solution is specifically designed to eliminate paper use-logs and logbooks in GMP manufacturing facilities, to enhance manufacturing capabilities. Logs inside the module can be accessed by all authorized personnel, anytime from anywhere, using the native app or supported browser.
Digital transformation can be characterized by taking manual activities and automating with software. Especially important to digital transformation are access to data, electronic logging and record keeping, automation as well as cloud.
Electronic forms are logbooks are critical to any digital transformation as they leverage the best aspects of the latest technologies to automate manual activities, ensure right-first-time execution, and ensure reliable, documented processes.
OpsTrakker eLogBooks and eForms can play an important part in your digital transformation. Leveraging the latest UI/UX methodologies, cloud, and industry best practice, OpsTrakker can be an integral part to any process improvement.
Review by exception is the process by which an automated system captures and flags process discrepancies, without need for human-review. Review by exception is a critical component to modern manufacturing solutions, to drastically reduce post-execution manual review, as well as ensuring that all process deviations, discrepancies, observations, and more are logged at the source.
OpsTrakker’s digital solutions decrease execution errors, allowing QA to focus only on review in case of exceptions, and thereby improving manufacturing operations. OpsTrakker functions as a reviewer to ensure that each activity is performed Right First Time and a separate Supervisor/QA review is not required for exception-free workflow executions.
Manual data entry is no longer a dream. Manufacturing organizations use countless electronic systems for process monitoring and continuous improvement.
OpsTrakker's solutions, enable electronic data capture in a variety of way. Not only is manual entry captured, but data is captured by barcode scanner, integration with external systems (i.e., AVEVA PI System, SAP, LIMS...), as well as tablet camera.
Data captured using paper and pen can take weeks to months to make it to these electronic systems.
OpsTrakker breaks down these barriers to manual data entry with seamless integration with external electronic systems. Integrations can be configured in rapid time to capture data at the source.
eForms are an electronic record keeping software to manage the documentation of common plant activities, such as work instructions, forms, checklists, and audits. eForms, as opposed to eLogBooks, document common plant activities, while standardizing activity completion and eliminating physical GMP documents.
The environmental impact of paper records is substantial. Each document must be controlled throughout its life cycle. By the end, the document must be archived and destroyed. Such a process can produce tens if not hundreds of thousands of GMP paper records across an organization. Taking such a view makes the environmental impact of such a system apparent. OpsTrakker eliminates the need for paper-based GMP records as all workflows and records are completed digitally. Thus, helping your organization reduce your environmental impact and support your sustainability goals.
OpsTrakker is designed to "Be Connected" and "Be Connectable. Integrations can be rapidly configured to achieve have value functionality in no-time.
Common integration points can include ERP (SAP), Historian, MES, CMMS, PLCs, DCS, EDMS, and more! OpsTrakker's suite of out of the box APIs make building these connections a breeze and eliminate the need to enter data to multiple systems.
OpsTrakker supports a variety of hosting architectures for cloud based or on-premise deployments.
OpsTrakker is configurable, off the shelf, software. Mean that eForms and eLogBooks can be created without custom code, to simplify the authoring process.
Such an approach, can support form creation by all types of users, including Operators, Front-Line Workers, and many more!
OpsTrakker's unique integration capabilities enable rapid integration with IoT across the manufacturing floor. IoT integration is critical for digital transformation, reducing operator errors, and ensuring that data is appropriately captured at the source.
OpsTrakker integrates with Historians, i.e. AVEVA (OSIsoft) PI System, to capture data directly from a historian, rather than duplicating integration points. Such an approach can significantly improve the time to value for IoT connections. Further, PI Vision integration is a fantastic method of visualizing data from OpsTrakker.
OpsTrakker was built with GMP in mind. With over 25+ years of consulting in Pharmaceutical Manufacturing Digital Systems, OpsTrakker complies with FDA, EU, and other regulating bodies, including compliance with 21 CFR Part 11 and Annex 11.
GMP (Good Manufacturing Practices)
21 CFR Part 11 and Annex 11 requires electronic systems to ensure digital documentation is trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. Systems must have electronic records with appropriate electronic signatures to capture relevant details surrounding the activities captured and all changes. Data in the records must be authenticated as belonging to the person performing an activity.
The electronic signature is essential in maintaining accountability. the identification must include several details for full accountability. These details include the users name (username or user ID), the timestamp of the action, as well as the meaning of the action. This validates not only the identity of the performer, but also the meaning of the activity.
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