Extended Regulated Manufacturing LIMS Released by Autoscribe Informatics

Autoscribe Informatics, a leading global laboratory informatics provider, announced the release of an updated version of its Regulated Manufacturing LIMS. A configured solution, based on the proven Matrix Gemini LIMS solution, the Regulated Manufacturing LIMS is ideal for all manufacturing organizations including those in highly regulated industries such as pharmaceutical, medical device and food production.

Regulated manufacturing environments require strict traceability of incoming raw ingredients and intermediates, with the final products. Consequently, the regulated manufacturing LIMS features recipe and batch management to provide the full traceability of the components of any given batch.

Other key functions integrated into the manufacturing flow include competency management to ensure that only trained and authorized staff can enter data into the LIMS, an instrument calibration and maintenance system (ICMS) that can prevent the use of out-of-calibration and out-of-maintenance instruments and a product grading module to check product quality against multiple specifications therefore ensuring that customers receive a product that meets their identified standards. Customer or market specific certificates of analysis can be produced based on these specifications.

Runsheet functionality is also built-in allowing QC tests such as blanks, spikes, and duplicates to be pre-defined within each runsheet to ensure quality control is standard in all testing. Environmental monitoring and testing of the production facilities can be defined, and corrective and preventive actions (CAPA) can be created and managed.

“The extended regulated manufacturing LIMS builds on our long-term knowledge and experience of working with regulated industries. This predefined solution provides the perfect entry point for pharmaceutical and manufacturing companies needing a robust solution,” said Tim Daniels, Marketing Manager, Autoscribe Informatics. “Validation documentation is also provided giving a head start to end user validation, further shortening the time to implement the system. The goal is to reduce cost, reduce risk and improve overall operational efficiency.”

This updated regulated manufacturing LIMS is available for projects starting from January 2021. It uses the same Matrix Gemini LIMS software as all Autoscribe solutions and is configured using our unique graphical configuration tools. This ensures that, if required, functionality can be configured without resorting to software coding and ensures software updates do not cause major rework of the entire system, saving time, reducing costs, and simplifying system support.