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ODTH is a logistics service provider of high-quality storage and distribution solutions. One of their key markets is the pharmaceutical industry, since ODTH specializes in ambient pharmaceutical storage and cold storage - providing extensive warehousing for vulnerable products. Rob Van den Berghen, QA Manager of ODTH responsible for all QA departments, chats with our customer success manager, Trine Michelsen about his Scilife journey.
Rob explains that years ago ODTH faced several issues, especially document creation and version control, that led to ODTH to look for a digital document management system. Previous to their leap to a fully digital system, paper copies lying around meant documents were easily misplaced, and accurate version control in a paper-based system became impossible as the company matured. This meant that older versions of documents were found to be circulating in some warehouses, for example. It was clear, the paper had to go!
In their search for a fully digital document control system, the quality team at ODTH weighed up different options on the market. The most immediate advantage of Scilife, Rob explains, is the prevalidation of the software.
‘We did a full cost benefit analysis to weigh up getting a pre-validated software or having to do the validation ourselves with external consultants, and we saw in this analysis that the burden of having to do a revalidation every time a supplier would issue a new version would very much overshadow the short-term cost benefits of having a slightly lower license fee.’
Rob Van den Berghen, QA Manager of ODTH
When asked about the implementation process of Scilife, Rob mentions that although there was initially quite a workload for the admins in setting the software up, it was also very natural. Getting the workflows set up was also straightforward.
When it comes to end user experience and learnability, Rob describes that it’s a very easy and short learning curve, thanks to Scilife’s user-friendly interface design where all modular features follow a similar template, and logical workflows;
‘We see that when we introduce somebody to the software, once they find their way around it, they work with it very easily because the templates of all the different modules have been set up quite nicely. If you work in the software for about a week, you should have most of the capabilities in your hands because the workflows are so logical. The workflows and everything behind it is built in a correct way. The software is very easy to use.’
Rob Van den Berghen, QA Manager of ODTH
When asked about his favorite Scilife features, Rob shares that what he values most is the connectivity between Scilife’s features and systems.
‘When you open a CAPA and it automatically triggers the forced review on the documents or vice versa, or from an event to a CAPA, that’s so useful. The links between the different modules, that's really the strong suit of Scilife.’
Rob Van den Berghen, QA Manager of ODTH
Rob also emphasizes that he really appreciates that the software is designed to make it difficult for users to make mistakes - which is an important safety and quality feature.
‘As a user, you cannot mistakenly publish a document or approve something that's not in your scope or something like that. In fact you can’t even see what's outside your allocated scope. You cannot do anything outside of the modules that you're assigned to. And within that module, you are restricted to your workflow. And so there is not much room for error.’
Rob Van den Berghen, QA Manager of ODTH
Scilife has improved internal audits, Rob explains.
‘Scilife makes everything a bit more alive now. It gives us the opportunity to open the software and see how many events are still open, how many documents we still have in drafts, stuff like that, during an internal audit. It gives you exact numbers in an internal audit, how many complaints you have and what stage of investigation they are in.’
Rob Van den Berghen, QA Manager of ODTH
Scilife’s implementation of feature requests is another big plus, Rob continues
‘What we especially like about Scilife is that we have seen it evolve. There is really continuous improvement, really taking into account the requests from customers and building the system.’
Rob Van den Berghen, QA Manager of ODTH
When it comes to advising other life science companies that are searching for eQMS solutions, Rob highlights that modularity will be beneficial to most organizations, so it’s something to keep an eye out for. He recommends starting off basic, in terms of features, and adding functionality bit by bit. Therefore, Rob emphasizes, it’s important to find a provider that accommodates growth.
Secondly, Rob stresses, organizations must take validation into consideration before starting out with a QMS service provider - especially Life Science companies. It makes a big difference whether the solution you choose offers prevalidation, and if you go down the road of doing it yourself make sure you’re aware that service providers often release new versions multiple times per year, creating a lot of validation work, Rob explains.
Finally, Rob mentions that it’s useful to really think about what processes you’ll put into your system before you start;
‘I remember that when we started, we said, yeah, we're just going to do procedures. We only need that. We had 30 procedures, so we just put 30 documents in the system. A few years later, every document that we gather we say, oh - we should put that in Scilife! Know your scope when you start and how you want to build up to your endpoints, then the easier the transformation should be.’
Rob Van den Berghen, QA Manager of ODTH
He also muses that, based on his own experience, it’s important to educate your team on using the features for what they’re designed to do.
ODTH’s experience with Scilife has been so beneficial that the company also uses it for their health and safety processes, not just in the quality department. Previously, events such as safety incidents and complaints were logged but never followed up, Rob explains. Now, Scilife has made event follow ups easy.
The biggest benefit of Scilife compared to their old paper-based system, Rob highlights, is that everything is safe in one easily accessible digital place. Now, all complaints and events are logged, and processing through them is much faster. Deviations are monitored in a much better way, and nothing is lost. As well as improving health and safety, streamlining Quality processes, reducing mistakes, and transforming internal audits, Scilife has saved ODTH time and resources through prevalidation.
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