Traditionally, batch operations records were—wholly or in part—collected, managed, and represented manually. As with most manual operations, there were concerns with accuracy, consistency, and repeatability. The arrival of 21 CFR Part 11 and Process Analytical Technology (PAT) brought a clearer regulatory roadmap (and framework) for transitioning to Electronic Batch Records (EBRs).
TrakSYS™ empowers users — across a wide spectrum of disciplines — to work together to efficiently meet operational excellence and quality-by-design goals.
Where EBR is concerned, TrakSYS™ effectively improves:
- Compliance & Quality
- Record-keeping & Cost Management
- Workflow & Corrective Actions
- Accuracy & Yield
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