Process audit

Definition of the term (“What is a process audit?”) 

The term pro­cess au­dit de­scri­bes the eva­lua­ti­on of the qua­li­ty ca­pa­bi­li­ty for pro­ducts, pro­duct groups and their pro­ces­ses wi­t­hin the qua­li­ty ma­nage­ment. It is part of the qua­li­ty ma­nage­ment sys­tem of an or­ga­niz­a­ti­on and is in­ten­ded to safe­guard ca­pa­ble pro­ces­ses re­si­tent against dis­rup­ti­ve factors.

Events

Pro­cess au­dits are con­duc­ted ac­cord­ing to a pre­de­fi­ned au­dit plan.
They can eit­her be per­for­med with re­fe­rence to the sys­tem or the project.

Sys­tem-ori­en­ted pro­cess au­dits only au­dit di­rect­ly af­fec­ted pro­ces­ses but not the en­t­i­re pro­duc­tion pro­cess. In con­trast, for the pro­ject-ori­en­ted pro­cess au­dit the Au­dit ta­kes place at fi­xed time in­ter­vals wi­t­hin a de­ve­lo­p­ment and plan­ning pro­cess in or­der to be able to de­tect de­fi­ci­ts immedia­te­ly

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Our di­gi­ta­liz­a­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the d.3 life sci­en­ces sys­tem is a ho­listic ECM/DMS sys­tem. The ECM/DMS sys­tem can be lin­ked to your exis­ting ERP sys­tem (e.g. SAP), thus en­ab­ling you to im­ple­ment al­most all do­cu­ment-ba­sed pro­ces­ses in your company. 
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GxP

All gui­de­li­nes for good working prac­ti­ce, which are par­ti­cu­lar­ly im­portant in me­di­ci­ne, phar­ma­cy and phar­maceu­ti­cal che­mi­stry, are sum­ma­ri­sed by the ab­bre­via­ti­on GxP. The “G” stands for

Process audit

De­fi­ni­ti­on of the term (“What is a pro­cess au­dit?”)  The term pro­cess au­dit de­scri­bes the eva­lua­ti­on of the qua­li­ty ca­pa­bi­li­ty for pro­ducts, pro­duct groups and