Last week, we hosted a Quality Leaders Forum (QLF) in Boston, bringing together quality pros from some of the most innovative biopharma and medical device companies in New England. The goal? Tackle some of the shared challenges quality leaders face in the field and discuss best practices in quality at every phase of clinical development. To help kickstart the conversation, panel speakers Panos Boudouvas, CEO of ZenQMS; Karin Ashkenazi, VP of Quality Assurance at ZenQMS; Cameron Jones, Sr. Director, Quality Assurance, Center for Regenerative Biotherapeutics at Mayo Clinic; and Scott Myers, Principal at Tunnell Consulting, shared their insights as part of an interactive Q&A.
Put enough people who are passionate about quality in the same room and you’re bound to get a lively discussion. Though it’s impossible to capture all of the great discourse in one post, these are some of the key takeaways that stood out:1. Adapting Your Quality Process Through Each Clinical Phase
Quality looks vastly different in preclinical than it does in phase III or beyond – but how do you adapt your quality processes and culture as your company grows? Here’s what bubbled to the top during the QLF.
- Kickstart a quality culture from day one: Too often, quality isn’t held in as high of regard in the preclinical phase as it is in the later phases. In fact, it tends to take a back seat due to misconceptions that it could slow down progress or it falls victim to the idea that we can always “come back to it later.” But quality pros know better. Preclinical is a critical time to establish a quality culture across the company. Start with an internal audit or gap assessment to uncover where quality is falling short, then create a plan to fill in the missing pieces. Above all, prioritize setting the foundations of quality now so that when you grow, a quality culture becomes second nature.
- Your manual is your blueprint: As you move from phase to phase, your quality manual should be your North Star. That requires it to be both detailed and transparent. It’s good to have a dream quality process in mind, but your quality manual shouldn’t be a wish list. Rather, it needs to be a true reflection of what you're applying to the business and a way to hold your team accountable. People come and go but the quality systems you codify will continue to be in existence.
- Keep commercial in mind: Even if commercial seems eons away, it should stay in sight. That means investing in more than the bare minimum quality processes and people throughout phases I and II. In fact, at one point in the QLF conversation, we heard “If they don’t have a quality person in their upper management, I know they don’t have a culture of quality.” In these transitional phases, finding the highest level of quality standards your company can sustain will be key to keeping you safely ahead of any changes and competitive in the market.
During the QLF, one fact took center stage: you don’t have to tell a quality leader how important having the right quality tools are; it’s the C-suite you have to convince. The million-dollar question is “how?”.
- Cost-avoidance & risk mitigation: The quality leaders who successfully got support from their c-suite agreed there’s power in showing the cost implications of not investing in quality tech. Try assigning a dollar amount to avoidable deviations or to the time and resources a manual system absorbs. Risk mitigation is also a big selling point. Eliminating the uncertainty from an inspection or an audit helps keep business moving forward without fear of regulatory disruptions or a lapse in consumer trust.
- Good quality = good business: One of the fastest ways to the c-suite’s heart is through their ROI. Beyond just protecting resources, show how the right quality tools add value to the company. For example, quality leaders at the QLF explained an investment in quality has been a differentiator for clients, investors, and potential buyers. While paper-based systems make investors doubt a company’s quality capabilities, tools like an eQMS prove the organization takes risk management – and investor dollars – seriously. And when a partnership worth millions rides on the company’s ability to pass a vendor audit, you can guarantee the c-suite will be paying attention. Simply put, learn to speak their language.
The thought of validating any potential software sets most quality teams on edge, and even the FDA has acknowledged the industry has over complicated the process. But the bottom line? It must be done, and a proper validation gives you peace of mind about your data and electronic signatures' integrity. Thankfully, there are some new industry best practices we can agree on to lighten the load without losing the impact.
- Swap CSV for risk-based validation: The old Computer Systems Validation (CSV) approach was all about checking the boxes without considering different levels of risk – and that created a lot more work and documentation than necessary. But the FDA’s recent move to Computer Software Assurance (CSA) and the new GAMP5 guidelines call for a mindset switch. This approach is risk-based and focuses on the software’s intended use, the phase of your product, and each feature’s level of impact on your operation and safety as a whole. Plus, it encourages leveraging the validation efforts of your service providers – something many were hesitant to do under the old guidelines. With this new school of thought, patient safety and product quality are still prioritized while workload and documentation are drastically reduced.
- Be picky with vendor selection: Applying the new CSA guidance means evaluating potential vendors with more scrutiny. Don’t settle for anything less than a vendor that’s ISO 9001 and ISO 27001 certified, has a SOC 2 Type II report, and demonstrates robust risk-assessment procedures. If your vendor doesn't have answers to your validation, security and privacy questions and/or won’t provide info on internal SDLC procedures and QMS, you should be cautious. Your vendor needs to understand your regulatory landscape and operate accordingly to help you avoid unnecessary risks.
Want to join us for the next QLF meetup? Reach out to get updates on when and where we’re convening next. Don’t forget, the ZenQMS team will be back in Boston for the American Society for Quality BOSCON event on November 6th and 7th. Get in touch if you’d like to schedule a meeting while we’re there!