EvidentIQ switches to Scilife, ensures 21 CFR Part 11 compliance and increases efficiency

About EvidentIQ

As a clinical data science group, EvidentIQ includes four companies (in Germany, France, the USA and Canada). It provides software solutions for clinical research, as well as offering a portfolio of related services. The EvidentIQ offering provides a pioneering end-to-end eClinical solution that meets increasing customer needs in clinical operations and clinical data management with a suite of applications and related services.

As Quality Managers, Rupert Sedlmayr and Rainer Küppers oversee quality management in all four companies, plus ensure quality assurance within each company. We wanted to know how incorporating Scilife solutions was beneficial for EvidentIQ. So our Customer Success Manager, Trine Michelsen, and Customer Service Representative, Fabiola Samueli, talked with Rupert and Rainer…

The Search

With their overview, experience and expertise, Rupert and Rainer both knew what kind of solution they were looking for. A solution that was aligned with their own way of doing things but could also make processes more efficient. Rupert explained how and why they chose Scilife:

“We had a screening process, with about thirty candidates, which we funneled down to three or four. We decided on Scilife mainly because it fits the Life Science sector.  It seemed to be tailor-made for us.”

Rainer provided a specific example of how the Scilife solution matched EvidentIQ's needs. For Document Control, they had procedures in place and the default procedure within Scilife was very similar, so they knew they could work with this.

The Setup

From the start, Rupert and Rainer had a long-term goal of how they wanted to use Scilife - a way in which they could manage all quality systems with standard workflows. They wanted to implement the system modules step-by-step, starting with Document Control. And they needed to align their existing process with Scilife, which takes time. Rainer outlined how it was for them:

“We needed some time to go through the procedures and it took half a year of validation and set-up. With Scilife's help, we managed to go live without hitting any roadblocks.”

Rupert elaborated on how Scilife provided support in the initial set-up:

“Scilife delivered the validation documents as well as self-training material, which was very helpful and the help files. In the beginning, we had regular meetings with the team. We also had personal support, what I really appreciated."

Favorite Features

So, with the solution setup and in use, what are the favorite features of Scilife for Rupert and Rainer? The simple interface and easy-to-use search system were the first two things they mentioned. As Rupert explained: 

“Overall, it’s not feature overkill. Scilife hits a sweet spot of having a lot of features, but not too many. I really like the flexible tag system, that lets the user search freely  and efficiently - very handy for the instagram generation!”

Rupert also liked the search filters in Document Control as it let him find things very quickly. Rainer agreed:

“The simplicity of the user interface is nice, e.g., in filtering. This makes the system very user-friendly.”

Expert Advice

As they both liked the Scilife features so much, we wanted to know if Rupert and Rainer would recommend our solutions to other organizations. They both answered ‘yes’ straight away, with Rupert explaining why: 

“Life Science companies have a big, big focus on validation of their systems. Scilife has a strong validation package, so I’d recommend it.”

Rainer was in agreement, but also gave some advice about needing time to set-up:

“We wanted to go live in one or two months and it took us six months due to limited resources. It’s important to plan sufficient resources for the implementation because you will need time if you want to do it properly..”

The Results

Rupert and Rainer clearly liked using Scilife. But were there clear results? Scilife Customer Success Manager, Trine Michelsen, asked if using Scilife has helped them maintain compliance. This was their synchronized response:

Rupert: Yes

Rainer: Yes

Rupert: Yes!

Rainer: Yes!

So that’s a pretty resounding confirmation. And as Rupert went on to explain:

“For us, a big point was 21 CFR Part 11 compliant signatures and document audit trails. In the future, we also plan to transfer our ISO 27001 information security management system to Scilife, which will bring compliance even more into focus. I am very confident that Scilife will be a big help.”

At EvidentIQ, the Quality Managers appreciated the set-up support, liked the Scilife features very much, and loved that it met their compliance needs. At Scilife, that makes us very happy. 

Are you on the lookout for an eQMS that ensures 21 CFR Part 11 compliance and increases efficiency? Then feel free to reach out and see how Scilife can support you.