EQMS Implementation & Use in the Clinical Trials Industry: Part 2- Moving from Paper to Software
Clinical Trials - 23 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 opinion about the migration from paper-based to electronic compliance and regulatory solutions in the Life Sciences in the larger sense.
Gordon: For many companies, the move from paper to software for GCP needs is far from being completed or even started. How do you address this analog to digital migration with your peers in Quality who’ve yet to adopt EQMS to automate Quality Operations?
Nathalie: The migration from paper to software-based Quality Management solutions has been, and remains a slow process. There are concurrent and additional challenges emerging now: people have to coordinate the approval and review of SOPs and training, for example, across head offices and time zones. They have to reduce delays that can cost money and slow projects (or even lose bids on projects, potentially), and they have to tighten loops and response times.
And then there’s the fear that many users still have of technology: some of it is generational, but a lot of it isn’t. Uncertainties often arise: ‘How do I know there’s a document there if I can’t see it? If I press the wrong key, will I break something?’ But the migration is also becoming more pressing: so many of the situations we’ve found ourselves in as a result of paper-based systems are really just untenable when we’re talking about regulatory obligations in clinical trials—and obligations to patients, which we keep foremost in mind!
Not only do you have, in many cases, people still using spreadsheets, enterprise email, but until recently, if you went back and asked someone, ‘Do you remember why you made that decision? Do you remember why you issued that recommendation?’—it’s so long ago, or the document is so buried that in some cases it’s irretrievable. And frankly they may simply not remember what guided that decision. The issue is compounded when you have turnover during a trial and there is no traceability for what the previous person decided.
So going from paper to electronic, we hear that people don’t feel secure–they don’t have their old paper ‘cheat sheets’, for example. But, if we speak of one specific area of Enterprise Quality Management Systems, Training Management—finding, tracking, maintaining and retrieving training on a paper-based system is such a challenge. One aspect, of course, with an EQMS is that the system is consistent and repeatable, and traceable in terms of all transactions: the audit trail, and the logs. One of the things we hear again and again when we’re training people is that they like to hold on to their dusty familiar 3-ring binder. However, when you have a multi-site, multi-country study, it can be difficult to find everyone’s binder.
Also, they like that ‘Bob’, their trusty office trainer, comes physically into their office to update them and train them. So there’s the real, tangible apprehension that many users face at the thought of losing their real-world classroom training. And the single biggest fear that many users have, and it’s obviously a universal human fear, is that they will potentially do something wrong. [She pauses.] Users fundamentally need to believe they are receiving adequate training to do their jobs.
The transition from paper to an electronic system is gradual and as it is happening they can see that we’re modelling their daily routines in the EQMS software—codifying and standardizing the processes and the trainings.