For a global pharmaceutical company, we designed and implemented a fully automated IT architecture for process data management. The project demanded in-depth knowledge of GAMP5, FDA 21 CFR Part 11, and general compliance requirements in the pharma industry.
We managed the solution design, risk assessment, and validation of the entire automation system.
The new system has reduced manual data entries by 95% and secured a full audit trail in compliance with current regulatory requirements. The validation process was completed with zero findings.
Contact us for an in-depth discussion about the project, or to find out how we can apply our experience to your challenges.
