GAMP 5 – Revolution or Evolution of CSV

Efficient Computer Systems Validation (CSV) and your risk is under control?

GAMP 5® takes up the topics “business validation” and “risk-based approach” and thus carries on GAMP 4® consistently. Are you informed and up-to-date with your CSV methodology and documentation standards?

What has happened until now …
In the past, expenditures for implementation developed in accordance with the requirements from the authorities. SOP structures, V-Model documents from URS to validation reports – on the whole a very extensive documentation for a computer system deployed in a regulated environment.

For this reason it became necessary to give some thought to new ways. On the one hand, the methods of software engineering, its quality assurance and the software deployment environments continue to develop; on the other hand, saving money is an important objective of today’s businesses.

And in the future?
The GAMP 5 is increasingly targeted at cost effectiveness and risk control to meet the justified demand for valid and safe computer systems embedded in the user’s business processes. Besides proper categorization of the software and thus also simplification for small devices, the necessary scope of documentation for systems, processes and test scenarios to be validated is managed by means of appropriate risk analyses. This then means a significant reduction in effort by actually concentrating on the areas truly critical for cGxP.

Let’s tackle it together
The Chemgineering Business Designers have been focusing CSV consistently on the functions and risks relevant to cGxP, and in this way they consistently implement the ideas of the GAMP 5® methodology.

Our toolbox offers self-explanatory guided templates that are methodologically adapted to the GAMP 5® guidelines. In this way, we enable reducing the validation documents and efforts to the essentials.

Join in now
We lead you safely to valid systems that will withstand any inspection using the best possible cost-benefits ratio. Would you too like to know how? …..Ask us!

Contact our CSV team