Sandeep Davé, our Chief Business Officer, recently had the opportunity to present at a webinar hosted by the ISPE-CaSA organization. The webinar focused on how to reimagine effective quality control in the Life Science industry.
The webinar was based on our company’s recently-published whitepaper, “Effective Quality Approach in Life Science: Charting a New Course to a Smart Quality System.”
In the webinar, Sandeep further explained the key principles outlined in the whitepaper of how to address quality and regulatory issues in the highly regulated Life Science industry. Sandeep drew from the success of the Semiconductor industry to focus on how Life Science companies can implement specific strategies to achieve their quality and regulatory objective while also continuing to deliver value to stakeholders.
What Needs to Change in Life Science?
We published the whitepaper and Sandeep presented on this topic because there is increasing frustration and dissatisfaction in the Life Science industry regarding the effectiveness of the industry’s approach to quality and regulatory issues.
Companies have invested countless time and resources attempting to meet their quality and regulatory objectives. Yet, despite the investment, this remains the #1 problem that companies are facing right now, according to a recent survey of Life Science leaders.
There is a clear desire to change, but the lack of substantial improvement indicates that a much larger quality control issue needs to be addressed. The industry must change at a fundamental level to achieve the desired outcome.
– The challenge is that Life Science has traditionally started with FDA regulatory compliance and worked backward to achieve quality. The implementation of Quality Management Systems (QMS) is focused on quality, safety, and reliability, yet there has been inconsistency in the procedures and the execution of procedures that flow from the QMS.
In other words, the focus has been on achieving the “what.” As a result, the human factor is that people doing the work do not see the connection and correlation between their procedures and the impact on work quality. The appropriate motivation is absent.
– Comparatively, quality in the semiconductor industry is driven by the “why.” The implementation of Quality Operating Systems (QOS) drives controls that directly affect product quality. By starting with the “why” instead of the “what,” it forces controls to be directly proportional to product quality.
Through a commitment to continuous improvement and optimization of the human factor through proper motivation, the Semiconductor industry has realized greater quality compliance and realized increased capacity to deliver value to stakeholders.
– The whitepaper and Sandeep’s webinar unpack the opportunity for Life Science companies to learn from Semiconductor successes to achieve their quality and regulatory objectives. By reimagining quality control in Life Science, organizations can deliver value to the business and sustain the business over the long term. This can be achieved while continuing to be fully compliant with regulations.
We encourage you to download the whitepaper and listen to Sandeep’s webinar to learn more about how to put into practice an effective quality operating system. By shifting to quality as the enabler of value creation and the foundation of a smart quality approach, Life Science organizations will be better positioned to achieve a positive ROI on their investment in quality and regulatory improvements.
– Download our whitepaper, “Effective Quality Approach in Life Science.”