Many life sciences manufacturers regard requirements such as Good Manufacturing Practice (GMP) regulations as compliance activities that are not directly related to quality or business objectives. For example, these companies often react to an inspector’s observations by altering a process to address the inspection comments rather than adopting quality best practices to improve company and product performance. This can have negative implications for overall product quality further down the road.
Today, leading life sciences companies are starting to view quality through the lens of an enterprise-wide, continuous improvement process that includes overall organizational goals versus a pure compliance exercise. Integration of the quality processes of an Enterprise Quality Management System (EQMS) with an ERP system can yield a number of benefits and help instill quality best practices throughout the organization as well as the supply chain.
Our 3-part webinar series will cover three areas: how to effectively and efficiently embed, report and control quality management best practices across the enterprise.
Episode 1: Enterprise Quality Management Systems, Embedding
The medical device industry is in a constant state of change, which is requiring leaders to often balance competing requirements from different stakeholders. How can you embed quality management best practices while maintaining a focus on customers, suppliers and regulatory agency demands?
During this first episode you will learn how you can embed quality management best practices across the value chain and drive sustainable growth.
Various use cases will be shown to illustrate the following outcomes:
- Improve nonconformance resolution times
- Increase quality issue visibility across the enterprise and supply chain
- Improve product safety and efficacy
- Greater customer loyalty
- On-time regulatory reporting
- Reduce the cost of poor quality
We encourage you to watch the replay of Episode 1 to learn more.
Episode 2: Enterprise Quality Management Systems, Reporting
ISO, GMP and CFR Part 820 quality system regulations were created to ensure medical device technologies and pharmaceutical therapeutics that treat, diagnose, and cure patients are safe and effective. But they don’t dictate how companies should meet these requirements. Ultimately, that’s up to the manufacturer, the expert.
For decades, paper-based processes that support these regulations have proven effective, but at what cost? Capturing quality information on the shop floor with clipboards is incredibly error-prone, and takes time to share, review and approve. And, when a quality event occurs, finding the true source of the problem is almost impossible.
Is there a better way?
This second webinar covers digital EQMS and how you can:
- Automate standard business processes and adverse event reporting
- Leverage risk-based analysis to find true root cause and prevent future issues
- Systematize best practices that help you achieve compliance with greater efficiency
We encourage you to watch the replay of Episode 2 to learn more.
Episode 3: Enterprise Quality Management Systems, Controlling
With increasing consumer and regulatory demands for higher quality products, having full visibility of a product’s lifecycle is becoming more important. From the initial stages of design and development, through the sourcing of suppliers and raw materials, all the way through the final stages of manufacturing, assembly and delivery, testing product quality and validating each stage of the process is critical.
During the third and final session of our webinar series, you will learn how digital solutions are connecting the enterprise and providing a closed-loop process for embedding quality best practices throughout your organization and at every stage.
Watch the final episode of this 3-part webinar series — Enterprise Quality Management Systems for Life Sciences, Episode 3 — and learn how QAD is helping life sciences manufacturers become greater advocates for improved quality management.
