|
All companies active in the manufacture and packaging of pharmaceuticals, generic products, healthcare products, food items, cosmetics, etc. need to comply with the special regulations of EMEA (the EU agency for medicines) and the FDA (the Food and Drug Administration) in USA.
A key role is played by the GMP (Good Manufacturing Practice) Guidelines. Over the last 30 years, the GMP Guidelines have been extended as cGMP (computerized GMP) and also Automated GMP / GAMP. The FDA also demands that hardware and software comply to GMP Guidelines. In Germany, the specifically German "V-Modell" guidelines based on US methods for the generation of automated systems have been developed.
Validation of a software, through which proof is established that the software is able to perform the purpose for which it was designed, is of key significance. The requirement is that not only the software but also the development process is able to satisfy the high demands placed upon it. Companies themselves are responsible for the validation of the software in application. |
 |
Spirit GmbH benefits from having an experienced team of software developers, who have been developing software to GMP guidelines according to the V-Modell for a number of years. Our QA system is aligned to the demands of the pharmaceutical industry and has been successfully audited both independently and by customers. Our software has also already been successfully validated. This gives our project teams the planning reliability they need and also the certainty that system validation can be successfully obtained.
Spirit customers are supported by automated test processes. This enables companies to meet all corporate-specific validation requirements to GAMP Guidelines via a simple, automated process and estimate the effort required.
.
|
