Justin L. Smith, Director of Product Management, Pilgrim Quality Solutions, an IQVIA company
What does a Next-Generation Quality Management System (QMS) look like for a Life Sciences organization? In a recent market research study conducted for Pilgrim Quality Solutions, quality and compliance professionals from the Top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies were surveyed on the “state of the state” of the business, regulatory, and technology landscape and their current QMS capabilities and needs.
This research provides fresh insights into the state of quality and compliance management in the Life Sciences industry, as well as quantitative data which demonstrates that many Life Sciences companies are preparing for or embracing Next-Generation Quality Management practices.
As a result of this study, six key imperatives for Next-Generation Quality Management were identified:
- Link Quality with Business Strategy
- Drive Real Product Quality
- Enable Harmonized Processes
- Allow Global Deployment and Reporting
- Enable Quality Culture and Effectiveness
- Deliver Enterprise Class Quality Solutions
Some organizations have made strides in each of these areas, while others are lagging. In many cases, the data shows that an automated enterprise QMS (eQMS) has a positive impact on an organization’s ability to achieve desired results.
For example, only 35% of respondents say that their suppliers are actively engaged and connected to their systems and processes. However, 62% of respondents who have connected, engaged suppliers are using automated eQMS. Those respondents who use automated eQMS have an advantage in supplier connectedness and engagement, which improves quality and reduces overall cost of quality early in the product lifecycle.
Another example is that respondents who have deployed fully-automated eQMS are much less likely to report that their quality efforts are reactive than those respondents with mostly paper-based quality processes. Only 28% of respondents who have deployed eQMS indicate that their quality efforts are reactive, whereas 44% of respondents who are mostly paper-based indicate that their quality efforts are reactive.
Next week, Pilgrim Quality Solutions will publish the results of this survey as an E-book to help life sciences organizations benchmark their current quality management processes against these industry findings and understand any gaps they may need to fill to stay ahead in the market.
EQMS and Quality 4.0
LNS Research examines the evolution of Quality 4.0 and the role an enterprise quality management system plays in its success.