Project Description
May 2010 – August 2010
Solid Dosage Blending Control System
| Organisation Function | Roche is one of the world’s leading providers of clinically differentiated medicines. |
| Project | Design and implement recipe driven solid dosage blending system. Regulated by the Food and Drugs Administration. Compliant with FDA 21 CFR part 11 – Electronic Signatures and Electronic Records. Compliant with Good Automated Manufacturing Practices (GAMP5). |
| How we help | Requirements capture (URS), detailed design (Design Qualification), software development, simulated testing, factory testing, on-site commissioning, installation qualification, operation qualification and performance qualification. |