The pharmaceuticals industry is involved with the research, development, production and marketing of pharmaceuticals and medicinal products for humans and animals. Very stringent guidelines must be complied with in pharmaceuticals industry. These include the preparation of software risk analyses, systematic management of the specifications (URS, FS, DQ), documentation and tests, as well as programming in the GMP environment, GAMP categorization, and the qualification of computer-based automation processes in accordance with GAMP 5 (IQ, OQ).
APE Engineering is a reliable service provider which fulfills all these requirements. APE Engineering develops on the basis of the V model to ensure quality. It automated the development process for one of the world’s leading players in this sector. As a result, that organization has been able to cut its engineering times by avoiding the multiple or manual generation of information. The HMI system is automatically generated free of errors. Meticulous documentation of the data points and intuitive navigation allow data to be retrieved in next to no time. This automated process also allows a reduction in the qualification overheads.
Regardless of whether you are looking for a new system or would like to refurbish a legacy one, let APE be your competent partner!