Audit Checklist

For life science and manufacturing companies, initiating a program for audit quality control that provides an "Audit Checklist" is crucial.

Pharmaceutical, biotechnology, medical device, laboratories and blood/tissue companies can all benefit from an audit checklist. To be effective the checklist for performing a system audit need not be elaborate.

  GLP Audits, GCP Audits, PV Audits, Vendor Audits, Supplier Audits

  General Quality Audits, ISO Audits, GMP Audits

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Preparing your Audit Checklist

Whether you're preparing for an FDA audit, an ISO Audit or a CLIA audit, many of the same basic principles apply when it comes to making an audit checklist. For instance, the audit checklist should ask:

• What is it that the quality auditor will be inspecting? (clinical trials? CAPA processes? training procedures? etc.)
• Was the system audit provoked? or is it a routine procedure?
• Will the auditor need access to specific documentation to prepare the audit report? (If so, this should be noted on the audit checklist.)
• Is there a planned methodology for the quick retrieval of documentation and proof of all essential audit trails?
• Will the auditor need to talk with specific personnel as s/he follows the audit procedures?

MasterControl Offers Audit Software that helps Develop an Audit Checklist

MasterControl is a provider of GxP process, document control and quality audit software solutions that enable life science and other companies to streamline quality and compliance processes in a fraction of the time required for manual or hybrid processes. MasterControl provides two audit solutions, each of which provides a different approach to developing the "audit checklist".

• MasterControl Audit™ guides companies through the process of creating an audit checklist, then tracking and reporting on audit findings. MasterControl Audit is designed for companies who want to ensure continuous quality and reduce audit risk.
• The MasterControl QAAD™ solution helps larger companies define "finding categories" that typically are linked to specific regulatory requirements (rather than, strictly speaking, to an audit checklist). This functionality facilitates investigating potential problems that may have been unforeseen. It also allows companies to report/trend in a manner similar to the FDA. MasterControl QAAD is used by well over half of the top 20 pharmaceutical companies worldwide.

For More Information

For more information about conducting an internal audit, and which approach for developing an audit checklist will benefit your company most, please feel free to contact a MasterControl representative