Audit

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

An au­dit checks whe­ther re­qui­re­ments, pro­ces­ses and gui­de­lines com­ply with re­qui­red stan­dards or norms. Due to the high si­gni­fi­can­ce of qua­li­ty, au­dits are of­ten car­ri­ed out 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.

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Our di­gi­tiza­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the dls | eQMS is a ho­li­stic ECM/DMS sys­tem. The ECM/DMS sys­tem can be con­nec­ted to your exis­ting ERP sys­tem (e.g. SAP) and, thus, map al­most all do­cu­ment-ba­sed pro­ces­ses in the company.

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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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Corrective action

De­fi­ni­ti­on of the term (“What is a cor­rec­ti­ve ac­tion?”) In ISO 9000, a cor­rec­ti­ve ac­tion is de­scri­bed as “ac­tion ta­ken to eli­mi­na­te the cau­se of

GAMP5

De­fi­ni­ti­on of the term (“What is the GAMP5?”) The GAMP5 is a set of gui­de­lines and best prac­ti­ces de­ve­lo­ped by the In­ter­na­tio­nal So­cie­ty for Phar­maceu­ti­cal Engineering