“Working with an ERP is primordial, as it gives you complete traceability for the product tracking process. The product code, the batch number, and the serial numbers can also be brought up quickly to in order find any possible flaws.”
Portrait of Debiopharm
Founded in 1979 by Dr Rolland-Yves Mauvernay, in Martigny, Switzerland, today the Debiopharm group is made up of five companies. Using the slogan, “We develop for patients”, Debiopharm specializes in the purchase and development of promising molecules in order to quickly bring innovative therapies to the largest number patients worldwide.
The global biopharmaceutical group, headquartered in Lausanne, employs nearly 420 persons, of which 350 are in Switzerland. In addition the group has developed a vast international network of over 400 experts whose principal role is to support the research and development processes for innovative prescription drugs. Using a multidisciplinary approach, Debiopharm has developed numerous therapeutic solutions aimed at relieving the suffering of people with cancer. Oxaliplatin and Triptorelin, both products developed and commercialized worldwide by Debiopharm and their pharmaceutical partners, allow the treatment of colorectal and prostrate cancer respectively. Debiopharm’s principal commercial partners are, amongst others, large pharmaceutical groups such as Sanofi, Pfizer, Ipsen, or Dr Reddy’s.
Dr Vincent Griffoul, Director of industrial opportunities
“Working closely with SolvAxis, we use a bespoke ERP that lets us be in conformity with the rigorous production norms in the pharmaceutical sector.”
An ERP for traceability
In the pharmaceutical universe, reliability is key in the manufacturing tracking process. More than an option in the pharmaceutical domain, an Entreprise Resource Planning application (ERP) becomes a necessity. “In today’s markets, a pharmaceutical company must reinforce its quality strategy using an ERP “, confided Vincent Griffoul, Industrial Opportunities Director at Debiopharm Research & Manufacturing in Martigny, Switzerland. “Working with an ERP is primordial, as it gives you complete traceability for the final product and all its components. The product code, the batch number, the serial numbers, and the operator can be brought up quickly to in order find any possible flaws.”
The choice of ProConcept ERP
Furthering his commitment at Debiopharm, Vincent Griffoul contributed to the search for an ERP that fitted the demanding quality requirements of a global biopharmaceutical group. Debiopharm already used one module supplied by SolvAxis, but only in the finance department, the pharmaceutical production was not included. “The marriage of finance to production made a lot of sense”, explains Vincent Griffoul. “We had spoken to a large number of companies and studied the ERP market, but no one application stood out from the crowd”.
In the end, Vincent Griffoul took part in a product demonstration from SolvAxis and its management application, ProConcept ERP. Even if at the time the application did not fully meet their manufacturing requirements (GMP, GAMP, FDA etc.), Debiopharm was convinced by its potential and by the business-specific skills shown by the Sonceboz based company. It was the start of a win-win collaboration, during which Debiopharm brought with it its own business specific know-how. “With SolvAxis, we have always been able to lay our cards on the table, developing a frank and honest relationship, an important citeria for us when working with our suppliers”, added Vincent Griffoul on the subject.
SolvAxis, “the data integrity facilitator”
In order to make the solution compatible with the pharmaceutical world’s strict requirements, certain functionalities need to be developed or adapted. As the cooperation with Debiopharm progressed, their expertise led to the implementation of different versions. At present, ProConcept ERP 11.1 includes several functionalities native to the system, such as the archival of paper documents, management and tracking of product versions, and even an audit trail : all elements that are indispensable to the correct functioning of Debiopharm. “By virtue of its proximity throughout the co-development process, SolvAxis has a been able to adapt its application to our sector’s functional requirements. In addition, the consultants have been very adaptable”, noted Vincent Griffoul.
All the adaptations made work tirelessly towards the same objective, that of guaranteeing “ data integrity” and not data corruption. “ProConcept ERP fills the role of data integrity facilitator. It is the keystone”, specifies Vincent Griffoul. There was a lot at stake, with functionalities such as descending traceability and ascending traceability, management of expiry dates, quality flows, and electronic signatures had to be developed in the software. But the SolvAxis employees didn’t just stop there.
Integration of regulatory texts
One of the biggest challenges, is to take the numerous norms to which pharmaceutical companies are subject, into account. After making several risk analyses, it was necessary to determine which validation methods should be applied to which processes. A dedicated team from SolvAxis was given to the task of validation with constant support from Debiopharm, “SolvAxis was capable of transforming the risk analyses, into qualification protocols”, specified Vincent Griffoul.
In the end, thanks to this collaboration, the SolvAxis developers were able to supply a category 4 software product, respecting the constraints imposed by the pharmaceutical industry. Furthermore, the project’s management due dates were kept. For Debiopharm, the close working relationship with SolvAxis has proved successful. “The result : we were able to anticipate the fit between the ERP and the strategies of the “European Medicines Agency (EMA) Master Data Management Roadmap “. This cooperation has allowed the development and set up of a functional tool that we have implemented throughout our maintenance and pool sector”, rejoiced Vincent Griffoul.
Thanks to the close working relationship with Debiopharm, SolvAxis is now in a position to supply preconfigured software specifically designed to conform to the reglulations. In the pharmaceutical sector the norms, GMP, GAMP, FDA 21 CFR part 11m and FDA 21 CFR part 210 and 211, along with part 820 are taken into account. Another important aspect, is the administrative work required in respect of the regulatory procedures, which has been automated, simplified and made more reliable. An advantage that Dr Vincent Griffoul summarizes in a revealingly lighthearted manner. “ SolvAxis has developed the functionalities for us that alllow us to work without getting bogged down. Finally our business is not IT, but making precription drugs”.
Debiopharm Group ™ Forum «après-demain» Chemin Messidor 5-7 CH-1002 Lausanne