Understanding the importance and complexity of Qualification/Validation (such as the ISPE GAMP® 5 guidelines) can reduce the cost, time and confusion of the regulatory process. Have confidence in solutions provided by experienced, dedicated, specialist teams that have implemented successfully the completion of validated solutions around the world
Active response to the latest regulatory developments e.g. PAT.
“Test and validate once – use many times” engineering strategy.
Built in FDA 21 CFR Part 11 features.
“Wrap & Comply” solution upgrade validation path.
Proven Ready to Use Templates for ISPE GAMP® 5 Qualification/Validation operations (Cat3 for product, Cat4-5 for Solution)
Complete life cycle support on the “V” model of the ISPE GAMP® 5 guidelines – maximizing productivity and efficiency.
This site is registered on wpml.org as a development site.
Cookies and privacy
Necessary cookies are required for our website to work properly and can’t be turned off. They are sent to your computer or device when you request a specific action or service, e.g. when you log in, fill out a form, or set your cookie preferences. If you set your browser to block or alert you about these cookies, certain parts of our website won’t work.
Thanks to statistical or analytical cookies, delivered by us and other companies, we can count the visits on our website and know the sources of traffic. The data we derive helps us understand what visitors like most and improve the website. If you don’t accept them, we won’t be able to improve your experience based on data from your visit.
Customization cookies allow you to configure our website to your preferences (e.g. language, region) and enable enhanced functionalities. They are delivered by us or by other companies. If you don’t accept them, we won’t be able to save your preferences and some services on our website may not be available.
Marketing cookies on our website are delivered by other companies and used to identify your interests and display relevant advertising content when you browse outside of our website. These cookies can enable social media features such as sharing and simplifying registration. If you do not accept them, you will still see online ads, but they will be less relevant.