An ERP for traceability
In the pharmaceutical universe, reliability is key in the manufacturing tracking process. An Entreprise Resource Planning application (ERP) is not optional in the pharmaceutical domain, it has become 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 essential, 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
Following his engagement at Debiopharm, Mr 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, and the pharmaceutical production was not included. “The marriage of finance to production made a lot of sense”, explains Mr 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, Mr Griffoul took part in a product demonstration from SolvAxisand 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 criteria for us when working with our suppliers”, added Mr 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 needed 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 been able to adapt its application to our sector’s functional requirements. In addition, the consultants have been very adaptable”, noted Mr Griffoul.
All the adaptations made work together towards the same objective, that of guaranteeing “ data integrity” and avoiding data corruption. “ProConcept ERP fills the role of data integrity facilitator. It is the keystone”, specifies Mr 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 that 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 the task of validation with constant support from Debiopharm, “SolvAxis was capable of transforming the risk analyses into qualification protocols”, specified Mr 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 timelines were respected. 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 equipment sector”, rejoiced Mr 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 regulations. 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 Mr Vincent Griffoul summarizes in a revealingly lighthearted manner. “ SolvAxis has developed the functionalities for us that allow us to work without getting bogged down. At the end of the day our business is not IT, but making prescription drugs”.
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