EQMS Implementation & Use in the Clinical Trials Industry: Part 4- Small vs. Large Companies
Clinical Trials - 5 October 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 opinion about the differences between how larger and smaller companies in the Clinical Trials space (and also companies in the Life Sciences in the larger sense) might implement Skillpad/SOLABS.
Daniel: Have you seen notable or interesting differences between smaller companies and larger ones, in terms of the ways they might adopt or use the SOLABS system with integrated with the library of Skillpad lessons?
Nathalie: With the more monolithic enterprise Quality software systems —not SOLABS QM in this context!—I find particularly in smaller companies in the Life Sciences, they don’t have the time, manpower, and maybe motivation in terms of ROI to implement, validate and test the top-heavy software systems. With a more streamlined, focused solution like SOLABS QM, though, they tend to like to start off with a limited scope, to address criticalities that arise either during regular operations, or to target a specific area that is being addressed because of an inspection or an audit. And once the workforce is confident and happy–they know the SOLABS QM interface and they’re trained, and the software is second nature–they’ll roll out other processes, or centralized document control and employee training, for example. This is generally how we see the adoptions or implementations take place.
We’ve looked at the Clinical Trials industry, and I’ve talked with Philippe [Gaudreau, CEO of SOLABS] about how companies in this space might implement EQMS. This area is currently underserved in my opinion, in all company sizes, in terms of a viable, user-friendly EQMS that will integrate the compliance elements with daily needs and centralize clinical quality operations. Some people still use enterprise email, spreadsheets, SharePoint for quality management–but it’s simply not workable or sustainable.
This is why we wanted to attend this conference (ExL’s 6th Clinical Quality Oversight Forum), to talk to folks, and to listen to the shortcomings of the software they may already use: to listen and to carefully ask them about what their needs are in this space. I mean, we currently group and nest Skillpad on-line lessons Curricula and Training documents in SOLABS QM, so why—for example—could we not use that grouping in a more project management/clinical trials way? Or the flexibility and configurability of the APPS, such as CAPA, as add-on processes? From what I’ve been able to observe in 24 years of experience in the clinical trials context, it’s the dependable, core infrastructure of the software in dynamic daily use that they need. I believe this would be very valuable to the majority of companies running clinical trials.
Finally, to further address the joint Skillpad/SOLABS offering, we can look at the larger case of user training with on-line easy to access clinical lessons such as our new suite of four lessons entitled Clinical Inspection Readiness. We must also take into consideration key management issues, like: Are all my users trained? Are all my people working from the same SOP document version? Do all my machines have the latest firmware installed on them, and are all my users trained on hardware and software upgrades?
Skillpad and SOLABS offer reliable solutions to these concerns. As partners, we feel we’re essentially ready for this segment of the market as of today, from a GxP/compliance and training standpoint–and with the addition of a couple of APPS from a more specialized clinical standpoint, we feel we’re the only offering that can address the unique requirements of Quality and Training Management in the Clinical Trials industry.