Successful implementation and Go-Live at greenfield manufacturing plant in Visakhapatnam, India / Full compliance and FDA approval ensured
Lueneburg, Germany -- The pharmaceutical major Dr. Reddy's Laboratories Ltd. successfully rolled out Werum's PAS-X Manufacturing IT Business Platform at their Indian greenfield site in Visakhapatnam. Dr. Reddy's deployed PAS-X for the first time as full-blown MES covering all operations from material receipt to production.
Dr. Reddy's required an MES Go-Live within a minimum of time. The system had to reliably document the batch production processes to meet all regulatory requirements. In order to ensure the approval of the greenfield plant by all regulators - especially the US health authority FDA - the pharmaceutical company was especially interested in a fully tried and tested MES.
"Based on the good experiences with PAS-X V3 at our Hyderabad plant, we took this system as template and rolled it out at our site in Visakhapatnam", says Mr. Sanjay Mantri, Director at Dr. Reddy's Laboratories Ltd. "This way, the PAS-X MES was set up within five months only and we were able to quickly start producing the first trial batches. PAS-X helps us to ensure full compliance and the highest quality right from the beginning."
The MES project was implemented by Werum's Asia Support Center in close cooperation with Dr. Reddy's Centre of Excellence.
The pharmaceutical manufacturer plans to install Werum's PAS-X at three further facilities in India.
About Werum Software Systems AG
With over 40 years of software development experience, Werum Software & Systems AG is known worldwide for partnering with its global customers to create state-of-the-art software products and solutions. Werum is the internationally leading supplier of Manufacturing IT / Manufacturing Execution Systems (MES) for the pharmaceutical and biopharmaceutical industries. Its PAS-X Manufacturing IT Business Platform is used by 16 of the world's top 30 pharmaceutical and biotech companies in more than 600 installations. Founded in 1969, the IT company employs about 470 people at its headquarters in Lueneburg, Germany, and at nine other locations in Germany, France, Switzerland, the United States, Japan, and Singapore. For more information take a look at our websites at www.werum.com and www.pas-x.com.
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Werum Software & Systems AG
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