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.

MasterControl's external audit management software provides automated tools that maintain compliance, strictly control and manage documentation and streamline product lifecycle processes so that companies can always be ready for a planned or unplanned external audit.

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How Does External Audit Management Work?

At the core of compliance and the successful completion of external management audits are well maintained documentation, organized training records (i.e, training records that show proof that document related training is taking place) and the overall success of tracking business practices from internal audit planning to customer complaints management and from change control to CAPA.

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.