April 26th, 2021 - Hollywood, FL
The Informatics division of Abbott is pleased to announce the STARLIMS Quality Manufacturing Solution QM12.2 release, which is built on the latest STARLIMS Technology v12 platform. Having the ability to interoperate between enterprise systems and applications and consistently execute methods as prescribed, is more important than ever in the regulated and non-regulated industries where integrity and collaboration are keys to success. Ensuring that standard testing methods and procedures are enforced, as well as providing direct integration with other laboratory systems and instrumentation, allows organizations to operate more efficiently, minimize data entry and transcription errors, and reduce costly and time-consuming investigations when demonstrating integrity of data.
The Informatics division of Abbott is releasing a new version of the Quality Manufacturing (QM) solution with functionality that will allow customers to be more efficient and address new and important use cases within their organization.
STARLIMS QM12.2 includes the following new features:
STARLIMS QM12.2 introduces our first version of the Laboratory Execution System (LES) integrated in the results entry by run application.
STARLIMS LES is a powerful generic workflow engine operated by a modern touch screen user interface. The LES is an ancillary module fully integrated with the STARLIMS QM 12.2 solution to support the laboratory with documenting important process steps associated with samples and testing materials preparation at the run level.
With the LES module, analysts are going to be able to document in real time their laboratory preparations associated with a product testing run such as sample, standard and solution preparations, and other important steps that need to be documented when processing laboratory samples runs.
The LES module, once configured, allows the analyst to perform the standard operating procedure (SOP), also known as method execution, in a guided manner, assuring compliance with the procedures and reducing the time necessary for the analyst to document the standard, solution, and sample preparations.
We are also pleased to announce that we have certified STARLIMS Quality Manufacturing solution with SAP S4/HANA. The STARLIMS interface with SAP S4/HANA is an extension of our existing interface with SAP QM-IDI and ESS. The interface allows the mapping and exchange of information between the two solutions.
The STARLIMS Quality Manufacturing solution interface with SAP’s business suite 4 HANA (S/4 HANA) Quality Management module allows customers to seamlessly leverage the benefits of both their ERP and LIMS solutions when verifying the quality of materials via inspection lots. The interface allows product material lot and specification data to be transferred directly from SAP into STARLIMS, reducing issues related to manual entry or transcription of data by automating the creation of material information and lots within the STARLIMS. Once inspection lot data is in STARLIMS, samples can be logged, results are recorded, and the usage decision is returned to SAP.
The STARLIMS interface with Biovia Draw and Biovia Direct for chemical structures and chemical reactions allows users to associate a chemical structure or reaction to a material within material manager and to a folder sample within folder lifecycle*.*Customers must have Biovia Draw and Biovia Direct licenses in order to use the Biovia interface available with STARLIMS Quality Manufacturing QM12.2. These licenses are not included with or supported by Abbott.
The Biorepository module allows the laboratory to manage biological samples separately from other laboratory materials. The new module allows users to define biological material and classifications for use throughout the system. The Biorepository module is extremely important for customers within the Pharma/Biotech and Agricultural/Crop Sciences industries that need to manage biological samples, containers, storage locations, testing, chain of custody and disposition.
The QM Application Programming Interface QM API v1.0 provides a series of pre-defined scripts to make REST API requests to the STARLIMS QM12.2 solution. The scripts provide the proper conventions that need to be followed to make these data calls/requests. This allows interaction and exchange between other software applications that need to consume data from STARLIMS. Some examples of data commonly consumed from STARLIMS include test, test plans, inventory, methods, materials, folder, project, clients, equipment, and services groups. Besides requesting information regarding different STARLIMS entities, the QM REST API also provides the ability to create new folders in STARLIMS.
With this release, STARLIMS interfaces with third party vendors’ latest versions of the chromatographic system were tested.
With this release, the QM12.2 product went under a series of stress tests in which primary default workflows (batch manufacturing, contract labs, and process samples) were subjected to simulated heavy data loads with the purpose of identifying and removing potential bottlenecks and incorporating performance improvements.
With this exercise, the team created the “Performance Testing Configuration Guide for STARLIMS Quality Manufacturing QM12.2” to be used for performance tuning engagements through Professional Services.
Several GxP improvements are included in the QM solution to enhance regulatory compliance. Additionally, with every release we ensure we address most of the reported concerns with existing functionality and maintain/update the Automated Verification Kit.
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