Streamline Decisions With A Connected QMS + EBR
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Key Takeaways
QMS plays a critical role in enabling review by exception (RBE) for pharma manufacturers. To achieve the aspirations of data-centricity and RBE, three capabilities are essential:
- "System of Systems" interoperability to other enterprise systems and data sources that contain critical elements of the electronic batch record (EBR).
- Access to or embedded Advanced Industrial Analytics capabilities across QMS and EBR for improved visibility into operational status, to enable automatic release, and more.
- Enhanced configurability across manufacturing and quality departments that empowers them with increased flexibility and agility.
The QMS market is growing, and leading-edge providers are moving toward enabling RBE, enhanced visibility, and increased flexibility through their applications. A future where RBE is more the rule than the exception makes pharma manufacturers more agile and efficient, a necessary shift in today's economy.
About This Event
Quality management systems (QMS) have historically been document- and event-driven, focused mainly on document management functions. Today's QMS solutions are changing in response to efforts to digitize manufacturing across industry sectors, including pharma. With 72% percent of life science manufacturing companies still reporting that a significant amount of their quality data is still in paper or flat file form, it’s clear more work still needs to be done industrywide to move closer to fully digitizing relevant data. In response, QMS providers are working to make their applications more data-focused than document-focused.
Key Takeaways
QMS plays a critical role in enabling review by exception (RBE) for pharma manufacturers. To achieve the aspirations of data-centricity and RBE, three capabilities are essential:
- "System of Systems" interoperability to other enterprise systems and data sources that contain critical elements of the electronic batch record (EBR).
- Access to or embedded Advanced Industrial Analytics capabilities across QMS and EBR for improved visibility into operational status, to enable automatic release, and more.
- Enhanced configurability across manufacturing and quality departments that empowers them with increased flexibility and agility.
The QMS market is growing, and leading-edge providers are moving toward enabling RBE, enhanced visibility, and increased flexibility through their applications. A future where RBE is more the rule than the exception makes pharma manufacturers more agile and efficient, a necessary shift in today's economy.
Nicole Sherman
Senior Product Marketing Manager
MasterControl
Within her role as a Sr. Product Marketing Manager at MasterControl, Nicole focuses on understanding the current market, and partnering with other departments to help communicate valuable product benefits that meet customer needs. This includes go-to market strategy, product positioning messaging, launch communications, and more. Prior to joining MasterControl, Nicole has spent over a decade in strategic consulting roles for both B2B and B2C organizations, spanning a range of industries, from healthcare to hospitality.
Sherman earned a bachelor of science degree from the Rochester Institute of Technology and a Master of Arts from Emerson College.
James Wells
Research Analyst
LNS Research
