Genzyme, one of the world's leading biotechnology companies, has selected to use Werum's PAS-X management executions system (MES) software at its Waterford plant in Ireland. Company's Waterford biopharmaceutical facility has been operational since 2003 with an investment of €260 million. Company's this Irish facility is the primary tabletting and bottling centre for its kidney dialysis drug Renagel (sevelamer). This facility will benefit from Werum's MES system as part of Genzyme's drive to improve quality, compliance and efficiency at the facility.
Genzyme has seven manufacturing facilities in Europe and has made its Waterford site a state-of-the-art manufacturing facility for large volume runs of its many products. The implementation of Werum's PAS-X MES system has been an essential part of its evolution and sets new standards of excellence in quality, compliance and efficiency.
Werum's PAS-X system also significantly drives Genzyme's right-first-time and real-time release strategy in manufacturing by introducing paperless electronic batch recording. PAS-X is an off-the-shelf product, specifically designed for the pharmaceutical and biopharmaceutical industries.
Manufacturing execution systems are software solutions that specify, execute and document all pharmaceutical productions in real time. The pharmaceutical companies are increasingly under pressure to ensure regulatory and quality compliance, as well as safe, cost-effective manufacturing techniques. An integrated system like PAS-X software can provide an effective platform to handle various business and production processes.
According to the company sources, its PAS-X software for the pharmaceutical industry ensures regulatory compliance, while reducing costs and increasing productivity. The system covers a range of functions necessary for specification and execution, from materials management to electronic batch recording. Apart, it also meets 21 CFR Part 11 requirements for handling electronic records and signatures.
PAS-X software helps in streamlining manufacturing processes, improving product quality, decreasing product cycle times and increasing equipment efficiency in compliance with good manufacturing practices and the US Food and Drug Administration regulated production and packaging environments, according to the sources.
The software itself is modular in design, allowing companies to pick right management system that will suit their needs. For example, Genzyme has opted for core functions of the software such as master batch record management, electronic batch recording, weighing, material tracking and deviation management.
According to the company sources, the modular components help to enable a flexible and scalable product configuration, allowing a broad spectrum of functionality. The core functions include recipe creation, weighing, electronic batch recording, warehouse management, material tracking and deviation management.
The development of the Genzyme facility at Waterford in Ireland started three years ago with the transformation of a 140,000-square-foot building into a state-of-the-art pharmaceutical facility.
Werum Software & Systems is a leading supplier of manufacturing execution systems for the pharmaceutical and biopharmaceutical industries worldwide. Twelve of the world's top twenty pharma companies use Werum's PAS X system to run their manufacturing business.