From the processing of raw materials to completing goods on the production line, STARLIMS is capable of providing the workflows that ensure products comply with specifications, safety requirements, and quality standards. Part 2 will discuss Quality Process Enhancement, Assurance of Compliance and Best Practices, and Logistics Streamlining and Automation.
Quality Process Enhancement
STARLIMS will allow the reduction of QA review and release processes. Testing within spec will be released automatically by “the release by exception concept.” The flagging feature will warn personnel when there is something unusual that requires further review. The solution will ensure the proper collection and testing of every scheduled sample as set forth by the environmental monitoring module. The efficiency of managing sample points can be increased through the utilization of visual floor plans.
Assurance of Compliance and Best Practices
The STARLIMS solution helps assure organizations that their lab will comply with various regulatory standards, including FDA 21 CFR Part 11 and the EU Annex 11 guidelines, ISO 17025, and cGxP. Labs can access a sample’s complete history, review full audit trails, obtain e-signature information, and other information. Also enabled are the tracking and management of analyst training and certifications for tests and methods, as well as the scheduling of courses and re-certification. Labs can also accurately oversee chain of custody through the use of electronic signatures.
Logistics Streamlining and Automation
Laboratory personnel will be able to study key performance indicators, which include sample turnaround times, out-of-specifications samples, and bottlenecks, promoting effective resource usage decision-making.
Based on availability and workload, organizations will be able to assign work to equipment and analysts. STARLIMS also enables the interfacing of multiple systems for data sharing, including third-party systems SAP, Chromeleon, Empower, and other internal enterprise systems.
Organizations will be capable of managing the suppliers of raw materials and petrochemical laboratory consumables.
Customer information management is also supported, along with the setting up of projects for lab testing. Capability features include test pricing, invoicing, and schedules for both sampling and testing.
Alpha Engineering LIMS Implementation
Alpha Engineering Associates, Inc. has been involved with the implementation of over 50 LIMS systems ranging in size from small, “off-the-shelf” software systems to very large, highly customized, multi-functional systems, including STARLIMS, for both governmental agencies and private enterprises. For affordable client-focused network consulting services and solutions, please call Alpha Engineering Associates today at (410) 295-9500.