Laurence Boy-Machefer is Head of Quality Assurance and Regulatory Affairs. She has been working with Keosys since 2015.
"Quality means doing it right when no one is looking." Henry Ford
Tell us about yourself and your role at Keosys
I’m a Bioscience engineer who early on specialized in Quality Assurance (QA) and Regulatory Affairs (RA). I have over 12 years of experience in the pharmaceutical, biological, and medical device industry. I have been with Keosys since 2015 as QA/RA Manager.
My main role at Keosys is to help the operational teams and the management team anticipate issues, and should they occur, understand them, fix them, and make sure they don’t reoccur!
What do you monitor/look out for in ongoing trials?
In the context of a clinical trial, QA involves many tasks such as creating, implementing, and keeping up to date standard operating procedures (SOPs) but also managing internal and external audits or inspections. I’m also in charge of regulatory intelligence and training of Keosys’ staff and medical experts.
As an independent QA, I don’t monitor individual clinical trials but all of Keosys’ portfolio in a transversal approach. This allows me to identify and minimize the occurrence of systematic discrepancies in data management within a given trial or in between trials. I also make sure our learning experience is shared, leading to the continuous improvement of our processes.
What are the key challenges in your role?
One of the key challenges for a QA is to always be ‘inspection ready’. Keosys undergoes on average 2 external audits or inspections a month and QMS documents must be up-to-date and available at all times.
In that context, our electronic document management system is a strong asset. It has allowed for audits to continue even when the pandemic had most of us working from home.
Furthermore, non-conformities or observations are also followed through an electronic CAPA system which allows for easy monitoring and swift resolution of issues.
What can also sometimes be challenging in my role is to keep up to date with the changing regulations. I always review new legislation and analyze how it will impact the business, for example, when GDPR was implemented back in 2018.
Speaking of issues, we often hear about risk-based approaches, what does that entail?
The definition of risk-based approach is pretty straightforward. You identify the highest risks to your key services and make them your priority for key performance indicators, policies, and procedures. If there’s one thing that customers and internal management are worried about, it’s a major discontinuation of those key services. So operationally speaking, a risk-based approach makes a lot of sense. Once your compliance program has successfully reduced the highest risks to acceptable levels, you move on to lower risks.
Regulators would tell you that they like risk-based approaches because it shows that the company actually thinks about risks!
If we go back to our clinical trial context, a sponsor can be conducting hundreds of clinical trials in many locations around the world. A best practice risk-based approach is therefore needed to anticipate, prevent, and address protocol, regulatory, and/or GCP non-compliance issues, should they arise. Each potential risk is then prioritized to enable the QA team, project team and science team to focus their efforts on specific aspects of the study trial process.
The clinical trial risk-based approach is actually very similar to the one used in the manufacturing industry.
What would you recommend to sponsors starting a trial?
Even though, good clinical practices apply to CROs, vendors and other providers, sponsors remain responsible for the overall quality of the trial.
What sponsors need to remember is that even though clinical trials are powerful tools to demonstrate the effectiveness of a clinical intervention or treatment, insufficient QA in clinical trials has been found to degrade their outcome.
Your QA, just like everything else, must fit your purpose. Nobody wants success at an unnecessary high cost because we focused too much on quality, but failure due to lack of compliance to QA requirements remains the most costly and detrimental thing of all.
In clinical trials, some QA requirements such as CE marked systems and certified 21 CFR Part 11 should never be overlooked. So, another key advice is not to forget to audit your vendor, and to look out for those key compliance aspects! Even though imaging can be a small part of your trial, this is really important, and I’m always surprised when sponsors fail to audit their imaging CRO.
That’s where the expertise and pragmatism of your QA managers come into play. A sound QA program will tremendously reduce the risk of inconsistencies and variations, thus improving the overall quality of your clinical trials and getting you one step closer to your goal: the regulatory stamp that will finally reward all your efforts.
However, for such QA programs to be effective, every stakeholder must embrace them. QA should be a visible actor, every step of the way, and QA trainings should be offered often so that, one day, you realize: QA has become more than just a ‘function’, it’s a habit.