The latest version of the PAS-X Manufacturing Execution System (MES) has been released by Werum IT Solutions for the biopharmaceutical and pharmaceutical industries.
The new PAS-X 3.1.8 features several improvements for efficient manufacturing. The update both facilitates regulatory compliance and supports drug makers to ensure high-quality in their manufacturing processes.
The latest trends in pharmaceutical manufacturing have been considered and reflected in the new PAS-X.
Senior Head of PAS-X product management at Werum Solutions says: "PAS-X 3.1.8 is future-ready.
"Our user forum PAS-X For Us actively participated in advancing PAS-X 3.1.8."
Senior Head of Quality Management at Werum Carsten Bierans adds: "Its use as an MES ensures data integrity and significantly reduces possible data integrity related issues.
"Together with the PAS-X For Us working group the MES-related data integrity positions of the pharma & biotech MES user community are defined."
Werum continues its usability initiative with a particular focus on quality in shop floor operations. With PAS-X 3.1.8, the most important material-related functions can now be accessed more easily and have been given an optimised user interface. Werum also introduced a dedicated dialog for material reconciliation with built-in best practices. The new automated material flow overview allows the operator to control the quantities that have been consumed and processed.
PAS-X customers will also benefit from the significantly reduced downtime needed to update the software version. A short downtime is crucial for modern bio-pharmaceutical manufacturing processes.
Head of PAS-X infrastructure and development tools at Werum says: "We reduced the downtime by more than 50%.
"We have achieved this high reduction rate not only through technical improvements, but through a holistic approach involving both the process itself and the documentation so that also the qualification efforts could be reduced."
PAS-X 3.1.8 allows a cumulative one-step MES product upgrade and data migration. It runs with the latest platform versions such as Oracle 12. Support of the new OSIsoft PI Event Frames simplifies integration of shop-floor systems.
PAS-X 3.1.8 allows an even smarter integration of Werum’s proven PAS-X solutions such as Track and Trace, KPI/OEE and the new Evaluations Package. The new PAS-X Evaluations Package helps pharma manufacturers unlock the full potential of shop floor data. In PAS-X, all production-related data and data of the interfaced IT systems converge.
Supported by the integrated and web-based PAS-X Evaluations Package, this combined information can be used to make production assessments and develop strategies for process optimization.
Senior director of PAS-X development at Werum Arndt Erdtmann says: "With the latest PAS-X release, pharmaceutical manufacturers benefit from a comprehensive compilation of innovations, functionalities, and usability improvements, which Werum introduced throughout the PAS-X 3.1 family."
Werum customers benefit from automated execution features such as automated material flow and automated equipment identification, each improving user efficiency and reducing risk of human error.
Data integrity is supported by alarm and events, directly retrieving GMP-relevant exceptions also from level 2 systems and enabling QM to significantly accelerate the release process of Batch Record Reports through review by exception. Further acceleration can be achieved by auto-closure functions, which unburden QM from checking batches without any exceptions and critical parameters at all, as manual release is no longer required.
PAS-X 3.1.8 contains the experiences and best practices of decades of successful MES projects in all areas of the pharma and biotech industries. Several Werum customers have already decided to incorporate PAS-X 3.1.8.
Senior PAS-X consultant at Werum Thorsten Grundmeier says: "With PAS-X 3.1.8, the most sophisticated and pharma-dedicated MES in terms of functionality and usability now becomes available on the market for customers in any region of the globe and from small to large-scale production.
"It is simply the best solution to fully utilize the key benefits of MES for pharma and biotech manufacturers: compliance, quality and performance."