EQMS Implementation & Use in the Clinical Trials Industry: Part 5 – Implementation
Clinical Trials - 2 December 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 what clinical trials companies should consider when implementing an EQMS.
Daniel: Can you talk about how EQMS implementation is typically handled in a life sciences company and what steps you would typically take during this crucial transition?
Nathalie: Well, as I’ve said previously, there are varying motivations for companies to implement and various times and ways in which they’re doing it:
Are they addressing an urgent issue? They may be responding to a regulatory or compliance/quality issue, and they may have to quickly target one area like deviations, or change control/CAPA; OR
Are they carefully phasing in EQMS, having thought it out, and having written up a business plan then project plan? Typically, Training and Document Control might be the first areas to be implemented when a user site is transitioning from paper, for example.
In many cases, the mindset progresses from first addressing and solving problems to addressing being compliant operationally, and then later on to Training and Document Control—and ideally that’s all in one automated and centralized EQMS. On all sorts of levels, we have to break down barriers when demonstrating the value of EQMS to companies. On the user level, that means making sure the training is engaging, so they’re not just clicking through required exercises mindlessly. We have folks with a teaching background working for us [at Skillpad] designing training activities that keep the interest level up–while making sure that employees produce appropriate test results at the end of their training.
"In general, low risk, high payback is the best place to start with any implementation, because it tends to excite people about further results. "
I take a risk-based approach to Quality, and during transitions like EQMS implementation, this is foremost in mind. We sit down and identify the vulnerable spots—the areas we cannot afford to have exposed, such as loss of license, exposure or adverse effects on reputation—and we pay them particular attention. We figure out where this transition is going to have the most impact, and break down how we foresee one decision affecting other elements in play. But also, being in the Clinical Trials industry, we don’t only consider business risk, we mostly consider human risk. We can’t forget that there are real people being affected by these decisions, whose health is being affected in a very real sense.
In general, low risk, high payback is the best place to start with any implementation, because it tends to excite people about further results. As someone with a project management background who has also overseen compliance in clinical trials, I always make sure to research, write and get a transition plan approved that describes the implementation in detail. I consider all the tasks and all the stakeholders, then write it, and get it signed off on. That is paramount.