External Audit Management


External audits are conducted to determine the validity of quality documentation through external audit management processes, to verify that quality documentation is accurate and to ensure that documentation corresponds with the regulations and standards that are required within regulated industries.

Le logiciel de gestion des audits externes de MasterControl fournit des outils automatisés qui garantissent la conformité, contrôlent et gèrent scrupuleusement les documents, et rationalisent les processus de cycle de vie des produits. De la sorte, les entreprises sont toujours prêtes en cas d'audits externes prévus ou imprévus.

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How Does External Audit Management Work?

Une documentation bien gérée, des enregistrements de formation organisés (qui prouvent que des formations relatives à la gestion de documents ont effectivement lieu) et le suivi efficace des pratiques commerciales, depuis la planification des audits internes jusqu'à la gestion des réclamations clients en passant par le contrôle des changements et les CAPA, sont autant de composantes essentielles à la conformité et à la gestion efficace des audits externes.

MasterControl enables the automation of audit preparation by controlling and recording all data for documentation, training, business processes and lifecycle of external audit management documentation. For example, when external auditors arrive, they will find quick access to documentation, easy-to-follow audit trails (for both documentation and training) and a history of digital signatures that have been recorded in accordance with 21 CFR Part 11 standards. CAPA, change control, customer complaint, previous audit and other industry-specific forms are also electronically available in conjunction to help in external audit management with related documentation and/or justification (e.g, for change control or CAPA processes). Analytics and reporting tools are also available and may be valuable during internal or external audit management processes.

For More Information on External Audit Management

To learn more about MasterControl's external audit management software system and additional automation solutions for regulated and standard-adhering industries, please feel free to contact a MasterControl representative.