Gamp Software Upd | FHD |

If you’ve ever been asked, “Is this software validated?” and felt a slight chill run down your spine, this post is for you. GAMP isn't a brand of software you can buy. It is a risk-based approach to validating automated systems, published by ISPE (International Society for Pharmaceutical Engineering). The current standard, GAMP 5 (Second Edition) , provides practical guidance to ensure that computerized systems are fit for purpose and compliant with regulatory expectations (like FDA 21 CFR Part 11 and EU Annex 11).

The next time someone asks, "Is that software GAMP compliant?" remember: It isn't the software that is compliant—it is of validating the software that matters. gamp software

Need help defining your User Requirements or selecting a GAMP 5 compliant SaaS vendor? [Link to your service/contact page]. If you’ve ever been asked, “Is this software validated