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FDAs Computer Software Assurance (CSA) – Part 2 of 3

Blog Home | Published: March 18, 2020

This blog is the second of a three-part series focused on the FDA’s Computer Software Assurance (CSA) initiative. It explains how to change compliance-centric mindsets. 

Here are the previous blogs for your convenience: 

Part One: How to Accelerate the Adoption of CSA 

Part Three: How to Foster a Quality-Focused Culture 

Nobody likes being told what to do, especially if, when you ask “why?” the answer given is “because I said so.” This happens in life sciences companies when an individual with approval authority operates with a compliance-centric mindset and won’t sign off unless you do what they say. Metaphorically speaking, it’s analogous to hitting someone over the head with a compliance hammer.

Without understanding why, you comply. What happens next is that people find workarounds, shortcuts, or hide things. Control is lost, compliance risks increase, and quality suffers. This is when compliance-centric mindsets rue the day.

It’s important to understand that compliance alone doesn’t guarantee quality. A paradigm shift is necessary; the focus must be placed on quality. But this requires a change in perspective; mindsets must change.

Changing Compliance-Centric Mindsets

Changing mindsets from compliance-centric to quality-focused isn’t easy. It’s possibly the most challenging change to make, but it’s necessary for a quality culture to take hold. According to McKinsey, "Creating a culture of continuous improvement is a difficult and long-term process, but it has been central to the success of leading companies in many other industries." (1) 

What an organization can do to effect change is first to recognize that they have a problem. Once recognized, then something can be done about it. Clear direction must come from the top. Objectives must be clarified along with goals. This requires an investment in time and money, and it’s not going to happen right away. This type of change takes time.

Technology as a Catalyst for Change

One way to make change happen is to implement a technology solution. With a new technology solution, the proverbial slate can be wiped clean and teams can find a better solution. Done correctly, this fosters collaboration and the ability to move forward with a common purpose. However, make sure old practices are not replicated in the system because technology is excellent at amplifying “bad practices,” making things worse rather than better.

Quality is a Top FDA Priority

One of the FDA’s top priorities is to focus on quality. (2) In part three of this series, we’ll show how technology, specifically the ValGenesis VLMS, can help organizations move from compliance-centric mindsets to a quality-focused culture. (3) You’ll gain insight into how technology can be implemented to effect positive change and improve quality.

Resources:

(1) Quest for Excellence: Driving a Step Change in Medical Products Operations, McKinsey & Company, www.mckinsey.com, January 2014.

(2) 2018-2020 Strategic Priorities: Center for Devices and Radiological Health, US Food and Drug Administration, www.fda.gov, January 2018. 

(3) Changing Compliance-Centric Mindsets to a Quality-Focused Culture – A Case for FDA’s Case for Quality, S. Thompson, Journal of Validation Technology Vol. 25, Issue 6, Dec 2019.

Summary

Changing mindsets from compliance-centric to quality-focused isn’t easy, but it’s necessary for a quality culture to take hold.



Author

Steve Thompson

Steve Thompson has worked in Life Sciences for over two decades in both Information Technology and Quality Assurance roles. He’s a certified systems auditor and has audited hundreds of companies globally. A published author, a frequent speaker at industry conferences, on the Board as a Director for PRCSQA, Editorial Advisory Board for ISPE, and Elite Faculty member for KENX, and Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program. He was honored with an APEX 2020 award of excellence for a peer-reviewed article he co-authored for Pharmaceutical Engineering on Blockchain. Currently, as Director Industry Solutions at ValGenesis, Steve helps Life Science organizations realize the potential benefits of advanced technologies, along with inherent risks.