CIMdata PLM Industry Summary Online Archive
28 June 2007
Implementation Investments
Aegis Software System Selected by Bristol-Myers Squibb to Enhance Company's Manufacturing Process Development
Aegis Analytical Corporation , a leading provider of manufacturing performance management software and services utilized by major life sciences companies, announced that Bristol-Myers Squibb Company selected Aegis' Discoverant® software to achieve greater process understanding and control during process development for new products.
Through its Process Analytical Technologies (PAT) and Quality by Design (QbD) initiatives, the Food and Drug Administration (FDA) has created a regulatory framework that encourages the use of innovative technology to deepen manufacturing process understanding. During process development and in commercial manufacturing processes, Discoverant can help companies reduce process variability, improve yields and reduce batch failures.
Bristol-Myers Squibb noted that Discoverant fits well into the company's strategy for implementing PAT and QbD. In addition, enhancing data analysis capabilities during manufacturing process development for a new drug will help Bristol-Myers Squibb meet regulatory expectations that are critical to the approval and launch of new products.
Aegis' technology platform and application set provide a collaborative root cause analysis and decision-making environment to improve operational efficiencies and accelerate time to value by understanding the sources of variability and achieving overall process predictability. Discoverant provides users with interactive access to all types of process development and manufacturing data that is integrated with powerful analysis, trending and reporting capabilities.
"Companies like Bristol-Myers Squibb who are leaders in leveraging PAT and QbD can use Discoverant to gain process understanding and reduce product variability - resulting in both regulatory and business benefits," said Robert Di Scipio, Aegis president and CEO.
Become a member of the CIMdata PLM Community to receive your daily PLM news and much more.
Tell us what you think of the CIMdata Newsletter. Send your feedback.
CIMdata is committed to your privacy. Your personal information will never be sold or shared outside of CIMdata without your express permission.