Domaines clés
Quatre domaines structurés qui comptent le plus pour ce sujet.
Rattacher les enregistrements qualité au produit et au lot
Les métadonnées relient chaque enregistrement au produit, au lot ou à la série concernés, afin que l’historique qualité reste consultable par objet, et pas seulement par date.
Stabiliser la chaîne d’approbation
Des rôles clairs pour la création, la revue et la publication des documents qualité préservent la traçabilité de l’opérateur au responsable en passant par l’assurance qualité.
Maîtriser les modifications de documents et de données
Les demandes de modification de documents maîtrisés suivent le workflow avec les preuves associées, conservant le pourquoi à côté du quoi.
Se préparer à l’audit de certification toute l’année
Un registre à jour et consultable signifie que le dossier de preuves destiné à la certification externe est toujours prêt, au lieu d’être constitué dans l’urgence.
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