What GxP Term Stands For in Focused Build

The GxP is a collection of quality guidelines and regulations. The "x" stands as a placeholder. G and P is always “good practice” and the X can be A,M,D,E,V e.g.:

• Good Agricultural Practice (GAP)

• Good Manufacturing Practice (GMP)

• Good Distribution Practice (GDP)

• Good Engineering Practice (GEP)

• Good Pharmacovigilance Practice (GVP)

When it comes to software changes most of these Guidelines require a special documentation to changes done to the productive system so that later auditors can follow up on who initiated a change, who authorizes a change who did the change etc. In Solution Manager ALM as well as in FB we follow most of these guidelines, we are also are SoX (Sarbanes-Oxley Act) compliant as well as FDA (Food and Drug Administration) which one of the most strict.

For Example for GVP it could be similar to FDA that additionally an electronic signature is required for specific status. Electronic signature is part of FB and can be used within FB as well as add on to standard ChaRM. In both cases you need to activate it. Config guide is available -just refer to the FB guide.