Effectively Manage Audits across the Enterprise with Your EQMS

January 23, 2013

By Sparta Editorial


Pharmaceutical companies must audit against many regulations and internal standards, with the primary audit groups focused on GMP, GCP, and GLP auditing.  Though they share the auditing title and are all responsible for auditing pieces of the drug development and production process, these three audit groups could not be more dissimilar.  A recent article titled “Seeing The Bigger Audit Picture with  an Enterprise Quality Management System,” details the differences among these auditing groups.  However, it also highlights some similarities and discusses how GMP, GCP, and GLP auditing can be effectively tracked and managed in the same enterprise quality management system (EQMS).

Bringing all audit processes into the quality system is a step towards interconnecting all quality related processes.  Within the EQMS, an audit observation can feed directly into the investigation and CAPA process, creating visibility throughout the process of issue resolution.  When issues are discovered during an audit, using an EQMS, companies can not only correct the issue where it was originally found, but also query for where the same conditions may exist globally.

As discussed in a previous blog post, consolidating auditing point solutions across the enterprise into a centralized, global system provides an opportunity to harmonize auditing processes while maintaining separate workflows, offline auditing guides, and record structure across the various auditing groups.  Another benefit to an enterprise audit system is that it gives executive management visibility to potential problems, ensuring critical decisions are made and actions are taken in a timely fashion.  The decrease in time needed to make decisions and take action helps ensure a safe product for consumers and saves a pharma company real money.

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