EQMS Implementation & Use in the Clinical Trials Industry: Part 3- Why SOLABS QM is Well-Suited for Clinical Trial Companies
Clinical Trials - 30 September 2015
We recently had the opportunity to interview Nathalie Bourgouin, PMP, and Senior Consultant and Project Manager at Skillpad, to gather her thoughts on the potential use of Enterprise Quality Management Systems (EQMS) for compliance in the Clinical Trials industry. In addition to having over 24 years’ worth of Compliance and Quality/R&D/GxP experience, she has also overseen compliance in clinical trials, and has structured e-learning and industrial training curriculums for the Life Sciences.
For this part of our multi-part collaborative blog series, we asked her about how she made the decision on behalf of Skillpad to work with SOLABS as their affiliated EQMS.
Daniel: What led you to choose SOLABS as your official EQMS solution partner to interface with Skillpad’s LMS? And specifically, why do you think SOLABS QM might be well-suited for the clinical trials space?
Nathalie: Evaluating software has always loosely been a part of my job description. When I was overseeing quality and compliance in clinical trials here domestically and abroad, I constantly evaluated what system our team would use, how we were going to capture, track and present our data, and make it safe and compliant and in a format that could be validated. It was also important to focus on traceability and ease of retrieval, particularly during regulatory inspections. Most recently in my work for Skillpad, I’ve focused on evaluating software for clinical trials, consulting with some of my peers who still work in that industry.
The requirements and context in which many Life Sciences EQMS providers are used to operating is manufacturing, and this market space is subtly yet vastly different from the clinical trials space. So, my peers and I have often found ourselves evaluating a lot of systems that are clearly intended for manufacturing purposes. Manufacturing is more or less ongoing, whereas clinical trials have a very definite beginning and end; manufacturing is in the realm of both science and business, while clinical bumps up more against pure science. And in Clinical, because of this sort of finite project nature, we find that we can treat these needs as more of a project-based challenge. These are all challenges, and some are clear hints to take note of when we’re evaluating EQMS software for clinical trials.
I looked for the important features right off the top, such as does it deal with the 21 CFR part 11 regulatory and compliance issues? I also tried to zero in on software that allows you to address the big issues: document reviews, approvals, training, and at the end of the day, in the clinical world it’s all documentation, so document control is critical. Lastly, I wanted to find a system that would allow me to follow-up on any smaller issues that could become larger issues if not tracked and addressed: things like quality events, change control, etc. Processes that can be triggered as a result of what one might find elsewhere.
For me, SOLABS QM scored high in many of these areas, all of which are necessary for clinical trials. It’s robust, user-friendly, and is software that can be used on a per-project basis. SOLABS QM offers streamlined, centralized areas such as document control and training, the backbone of all clinical trial projects. The additional flexibility of the SOLABS QM APPS interface, which provides specific tools for processes like tracking quality events, change control, deviations and out of specification APPS is a definite bonus.
It was important for me to note that SOLABS QM is Quality- and User-focused, rather than IT- or database-focused—and you can tell by the way the system is set up that the user was a foremost consideration in the design phase of the software. Several of SOLABS’ competitors are very top-heavy and rely a great deal on integrations, long, elaborate configuring with other secondary interfaces. Other EQMS say that they can make their systems work for clinical trials, but then you find out that they need to add on this and that, and configure it endlessly to make it usable.
So originally, as I said, I started with the big stuff: with compliance and risk-based quality in mind, I first ensured SOLABS met all the requirements. After checking that off my list, I proceeded to test and challenge it [she laughs]… and I tried to break it. I’m happy to report I wasn’t able to! People would also ask me, ‘Can it do this?’, and there would always be a way—so obviously there’s been a lot of thought put into this system.