Could you briefly describe your company?
HEBIAS is a privately held Belgian consultancy company founded in 2018 by Stefaan Vansieleghem and Bénédicte Lerouge. As an innovative player in the healthcare market, HEBIAS concentrates on guiding pharmaceutical companies through all their market access related activities, to detect the most advanced strategy to help both the patient and the community.
HEBIAS is active in the Belgian and Luxembourg healthcare environment and targets the highest possible societal health gain related to innovative drugs, medical devices and diagnostic tests. To translate this vision, HEBIAS provides guidance towards pharmaceutical companies from set up of clinical studies till post-launch besides classical market access consultancy. In addition to guidance, HEBIAS performs data collection, data analysis, set-up of dynamic tailor-made models and provides related reports. To enable pharmaceutical companies to penetrate the market more efficiently after registration, the results of its research are made available towards its clients through dynamic and tailor-made models that map the potential scenarios to be worked out in more detail once alignment between HEBIAS and the client.
The QMS implemented by HEBIAS involves the following activities: Strategic market access related advice, guidance and set up of supporting documents to allow entrance and maintenance of drugs, medical devices and diagnostic tests on the Belgian and Luxembourg market.
What is your role in the company?
Stefaan is co-founder of the Hebias company, General Manager and Market Access Consultant. Recently, Armand Voorschuur has enforced the team and will be the main liaison between partners and the Hebias team. Stefaan formulated the wish to implement a Quality Management System and to strive for ISO 9001:2015 certification by mid-2020. According to plan, the certification was achieved on 1 June 2020. In his search for Quality Support to accomplish this, he came in contact with Hilde De Bondt from QuaPro Consulting. Hilde likes to help organizations realizing their strategic challenges by designing & implementing the best business solutions at the right moment.
After a gap analysis to compare the current status with the desired situation, a step-by-step plan for setting up the HEBIAS QMS was made, followed by the implementation of an ISO 9001 quality management system in the organisation.
What were the major pain points prior to using QualityKick?
Seen the limited resources available and to avoid much manual work and follow-up, very quickly we started looking for a software tool to support the document flows and training for our co-workers.
Would you describe the reasons you decided to buy QualityKick?
QualityKick is a modular system, which means it offers flexibility in enabling the different modules depending on the needs and you can always add more modules while you are starting to use the system more. You only pay for the modules you are using and not for the whole package. The overall pricing is very fair as the prices differ depending on the user type and read-only users are very cheap!
By using QualityKick, which are the benefits for your company?
Manual signing, printing and scanning has become obsolete as we are managing it now with QualityKick using “Electronic signatures”. This helps us to reduce risk and be ready for an audit or inspection at any time. QualityKick is also a very user-friendly system, easy to use and just a limited training time is needed, which makes it very efficient. The system informs via email when any action needs to be done by the user like reviewing or approving a document and training. All pending actions can also be seen in the dashboard of every user, which gives a nice overview of the workload.
Further information on HEBIAS is available at www.hebias.be