Wednesday, September 23, 2015

Cost-effective, high-quality and large-scale MBR creation.

Development of new drugs, process harmonization and standardization or efficient operation of manufacturing execution systems (MES) – pharmaceutical and biopharmaceutical companies face major challenges to remain competitive. In this regard, electronic master batch records (MBRs) are an essential factor.

Martin Gent
Werum IT Solutions now offers its customers a new service: “Design as a Service” – a complete solution for the cost-effective creation of lean, high-quality and streamlined MBRs. The package comprises pre-configured PAS-X Content Packages with industry-specific content based on best practices, ready-to-use concepts and guidelines for the efficient creation and optimization of MBRs and profound, first-hand PAS-X knowledge. As the company who developed PAS-X, Werum is able to provide an “end-to-end” MES solution that meets all customer requirements in terms of software, delivery and services.

“Our ‘Design as a Service’ offering allows us to provide our pharmaceutical and biopharmaceutical customers with much more than the mass conversion of paper-based recipes into digital copies which is usually referred to as MBR factory,” says Martin Gent, Consultant, Werum IT Solutions GmbH. “Our approach starts at an earlier stage and we reflect about the manufacturing processes together with our customers. Even during the MBR specification phase we consider the entire spectrum of manufacturing procedures, system environment and review processes. In combination with the profound process know-how of our staff we ensure optimized high-quality MBRs from the very beginning – an important prerequisite for the efficient operation of our PAS-X MES. Customers who want to save costs by commissioning the mere creation of MBRs often face extra costs when they need to revise their MBRs.”

Through “Design as a Service”, Werum does not only support the cost-effective high-quality creation of MBRs for new MES installations but also supports customers who already operate an MES and rather focus on process harmonization, PAS-X upgrades or the MBR creation for new products (ad-hoc service). As PAS-X is Werum’s proprietary software product, Werum can also consider future PAS-X functions when creating MBRs. “Design as a Service” addresses all phases of MBR development, such as MBR specification, MBR creation and finally MBR verification. The resulting MBRs are lean, efficient and optimized to meet the customer requirements in regard to “Review by Exception”.


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