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

An au­dit checks, if the re­qui­re­ments, pro­ces­ses, and gui­de­li­nes meet pre­scri­bed stan­dards or norms. Due to the high si­gni­fi­can­ce of qua­li­ty, au­dits are of­ten con­duc­ted as part of a qua­li­ty ma­nage­ment. This dif­fe­ren­tia­tes bet­ween two ty­pes of au­dits wi­t­hin the sta­tic and dy­na­mic qua­li­ty management.

On the one hand, the­re are au­dits with va­li­da­ting cha­rac­ter wi­t­hin the sta­tic qua­li­ty ma­nage­ment, which pro­vi­de pro­ofs for the con­trac­tu­al agree­ments and which are only con­duc­ted once. On the other hand, the­re are au­dits ta­king up on de­ve­lo­p­ment trends in the dy­na­mic qua­li­ty ma­nage­ment, which pro­vi­de the ori­gi­na­tors of chan­ges with clear feed­back on the ef­fects of the im­ple­men­ted measures.

An au­dit can eit­her be an in­ter­nal au­dit and thus self-eva­lu­ti­on or an ex­ter­nal au­dit. The ex­ter­nal au­dit dif­fers from the in­ter­nal au­dit in that it is a cer­ti­fied pre­re­qui­si­te in qua­li­ty ma­nage­ment and is car­ri­ed out by re­co­gnis­ed bo­dies. This could for ex­amp­le re­sult in an of­fi­cial certification.

The au­dit trail should also be men­tio­ned in con­nec­tion with the audit.
An au­dit trail is a pro­ce­du­re, which mo­ni­tors the at­temp­ted and im­ple­men­ted ac­tions of per­sons du­ring a pe­ri­od of time, elec­tro­ni­cal­ly do­cu­men­ting them. Mo­reo­ver, the au­dit trail can also be a tem­po­ral se­quence of ac­tions, sta­tu­ses and sys­tem sta­tes, which can be re­crea­ted ac­cord­ing to traces such as bookings.

What are the different types of audits? 

Audit types according to the subject (extract):

    • Sys­tem au­dit (fo­cus on the ma­nage­ment system)
    • Pro­cess au­dit (fo­cus on in­di­vi­du­al processes)
    • Pro­ce­du­re au­dit (syn­onym for pro­cess audit)
    • Com­pli­an­ce au­dit (va­li­da­ti­on of con­for­mi­ty with a set of rules)
      and many more

Audit types according to the status of the auditor:

    • In­ter­nal au­dit (an em­ployee of the or­ga­niz­a­ti­on being au­di­ted acts as the auditor)
    • Sup­plier au­dit (the qua­li­ty ma­nage­ment re­pre­sen­ta­ti­ve of a cus­to­mer au­dits his supplier)
    • Cer­ti­fi­ca­ti­on au­dit (by an in­de­pen­dent au­di­tor of a cer­ti­fy­ing authority)

Your path to digitization — Discover our software

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. 
Live insight into the GxP-compliant document management system by d.velop Life Sciences

Share now!

Share on email
Share on facebook
Share on linkedin
Share on twitter
Share on whatsapp

Learn more about

Enterprise Content Management System (ECM)

De­fi­ni­ti­on of the term (“What is ECM?”)  ECM is the ab­bre­via­ti­on of En­ter­pri­se Con­tent Ma­nage­ment. This is the ma­nage­ment of all data and in­for­ma­ti­on ge­ne­ra­ted in

ISO 13485:2016

The ISO 13485 is an ISO norm con­tai­ning the re­qui­re­ments for a com­pre­hen­si­ve ma­nage­ment sys­tem of the crea­ti­on of me­di­ci­nal pro­ducts. The most re­cent edition