CSV, 21 CFR Part 11, Annex11/15

GAMP 5 – Revolution or evolution of CSV

Get a grip on economic Computerised Systems Validation (CSV) and the risk.


GAMP®5 approaches the subject of "economic validation" and "risk-based approach" directly, and therefore represents a consistent progression of GAMP ®4. Are you aware of this, and are your CSV methodology and documentation standards "up to date"?
The story so far…
In the past, the efforts for implementation grew alongside the regulatory requirements. SOP structures and V model documents from URS to validation reports all add up to a rather extensive amount of documentation for a single computer system deployed in a regulated environment. 

It was thus imperative to consider new ways. On the one hand, the methods of software engineering, quality assurance, and operational environments of software keep developing; on the other hand, there is a growing trend to cut costs.

And in the future?
To meet the legitimate requirement for valid, secure computer systems, embedded in the business processes of the user, GAMP 5 is now increasingly paying attention to economic efficiency and risk management. Apart from the correct categorisation of software and the associated simplification for small devices, adequate risk analyses are used to determine the required extent of documentation for the test scenarios as well as the systems and processes that are to be validated. Actually focussing exclusively on cGxP-critical factors entails a significant reduction in effort.

Let's do it together ...
The Chemgineering Business Designers have always focussed CSV on cGxP-relevant functions and risks, that are putting the methodological ideas of GAMP 5 into practice.

Our toolbox provides adaptable, self-explanatory "Guided Templates", which are methodically adapted to the GAMP 5 requirements. This permits the reduction of the validation documentation and efforts to the essentials.

Welcome to the club ...
We guide you to valid systems that can withstand any inspection, while maintaining an optimal cost-benefit ratio. Do you want to know how? ..... Ask us!

Click here to see the reference projects "Computerised Systems Validation - CSV, 21CFR Part11, Annex11/15 – general"


For further information please contact Dr. Thomas Karlewski

Chemgineering Business Design AG | Binningerstrasse 2 | 4142 Münchenstein | T +41 61 467 89 00 | F +41 61 467 89 01 | www.chemgineering.com | info@chemgineering.com