Client core business
The customer develops decentralized molecular testing solutions to bring precision medicine closer to patients.
How Modis added value
We helped the customer comply with GMP regulations and improve manufacturing efficiency by implementing and validating an electronic batch record system. Our project manager guided the team through the initial requirements and programming steps to the full implementation of the new technology into the customer’s existing manufacturing line. We added value by ensuring end-to-end quality and FDA-compliant manufacturing processes.
Implementing an electronic batch record system is a challenge for many companies. Thanks to the support of the skilled senior project manager from Modis, we were able to approach this project in a methodical manner. Numerous reviews have been completed with all internal and external stakeholders. By consolidating and keeping a clear overview of all information, systematically placing the right holding points and making the right communication and escalation calls, we delivered the project on time and on budget.