DELIVERING QUALITY IN A FAST-PACED ENVIRONMENT
Efficiently managing the testing of batch processes and ensuring that products meet defined specifications and safety requirements is critical to your organization’s success.
The STARLIMS Manufacturing LIMS solution allows your lab to monitor both batch and continuous manufacturing processes while streamlining procedures and improving automation. Integrate with other business critical systems, such as Enterprise Resource Planning (ERP) and Process Information Management Systems (PIMS) to optimize your operations throughout the entire manufacturing lifecycle and get safe, high-quality products to market faster.
ENHANCE QUALITY ASSURANCE PROCESSES TO DECREASE TIME
- STARLIMS has been designed to help your organization comply with a wide range of different regulatory standards, including FDA 21 CFR Part 11 and the EU Annex 11 guidelines, ISO 17025, ISO 13485, ISO 9001, and cGxP
- Reduce quality assurance review and release processes. The release by exception concept allows all “within spec” testing to be released automatically. Flagging features alert users when something is out of the ordinary and needs additional review
- Access an entire sample history, display full audit trails, extract e-signature information, and much more
- Track and manage analyst training and certifications for tests and methods, and schedule courses and re-certification
- Ensure that all scheduled samples are properly collected and tested with the environmental monitoring module
- Efficiently manage sample points using visual floor plans
MANAGE AN EFFICIENT SAMPLE AND PRODUCT LIFECYCLE
- Manage protocols, sample inventory, studies, pulling schedules, conditions, and locations to achieve your stability management goals. You may migrate your legacy stability study system into STARLIMS
- Configure triggers, sample points, re-sample and re-test workflows. Link to open investigations through the integrated investigation module
- Automatically schedule sampling points and QC samples based on multiple criteria and on hourly, daily and annual schedules
- Create recipes and batches associated with recipes. Download the formulation management application brochure (PDF, 386 KB) for capability details
- Effectively manage your batches, from creation to delivery of a final Certificate of Analysis (COA). Control the tests performed on batch samples based on the frequency of testing and prior test results