Audit

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)

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Learn more about

EU GMP Guidelines Chapter 7

Chap­ter 7 “Out­sour­ced Ac­ti­vi­ties” of the EU GMP Gui­de­li­nes deals with the re­spon­si­bi­li­ties of the con­trac­tor and con­trac­ting en­ti­ty in the case of out­sour­ced activities.

FDA 21 CFR Part 11

FDA 21 CFR Part 11 , the Ame­ri­can Food and Drug Ad­mi­nis­tra­ti­on (FDA) spe­ci­fies re­qui­re­ments for elec­tro­nic do­cu­ments, elec­tro­nic si­gna­tures and hand­writ­ten si­gna­tures ap­p­lied to