Focusgebieden
Vier gestructureerde gebieden die voor dit onderwerp het belangrijkst zijn.
Koppel kwaliteitsrecords aan product en batch
Metadata koppelt elk record aan het product, de batch of de partij waar het bij hoort, zodat de kwaliteitshistorie op zaak zoekbaar blijft en niet alleen op datum.
Stabiliseer de goedkeuringsketen
Duidelijke rollen voor aanmaak, beoordeling en vrijgave van kwaliteitsdocumenten behouden de herleidbaarheid van operator via manager tot QA.
Beheer document- en datawijzigingen
Verzoeken om beheerde documenten te wijzigen lopen via de workflow met bewijs erbij, zodat de reden bij de wijziging blijft.
Bereid u het hele jaar door voor op certificeringsaudit
Een actueel, doorzoekbaar register betekent dat de bewijsvoering voor externe certificering altijd klaarstaat in plaats van in haast te worden samengesteld.
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