March 24, 2022

This article is part two of a two-part series focused on GMP quality audit management.

The very concept of an audit puts auditors on one side and auditees on the opposite side. This is especially true with a Good Manufacturing Practice (GMP) audits, a compliance requirement for companies regulated by the FDA. Companies that adhere to ISO and similar quality standards also undergo GMP audits.

For example, take the case of a medical device manufacturer that has received a warning letter from the FDA. The citation stems from inadequate responses to GMP violations such as ineffective corrective actions and failure to validate process changes that resulted in deviations. It’s easy to understand why the company might feel picked on or even threatened. Compliance and the company’s ability to continue doing business are at stake, after all.

This article looks at the reasons that audits have historically taken on negative connotations. Furthermore, we discuss how regulated companies can turn the situation around.

Common Challenges of GMP Audits

Regulatory bodies throughout the world require quality audits as an important tool to measure quality and drive continuous improvement. The FDA and its counterparts in Canada, Australia, Japan, and Brazil promote a global approach to audits in a cooperative program.

As a regulatory requirement, GMP audits can bring tremendous stresses to auditees, hence the adversarial stance. Regulated companies go through compliance audits not just once but regularly. The frequency adds to the pressure for auditees. Also, the very nature of audit means a company will get either positive or negative findings. For auditees getting the latter, it’s understandable if they see the process as an occasion for fault-finding and finger-pointing.

GMP audits are daunting, but why do they have to be so stressful? For companies that still use a paper-based quality management system (QMS), it’s the main source of their struggles. Organizations using unconnected ERP, PLM, CRM, and other systems also typically find GMP audits challenging.

Starting with planning and scheduling, a manual process will entail meetings and conference calls to bring together auditors, a quality team, and other stakeholders. Voluminous paper documentation of quality processes will have to be prepared.

During the actual audit, it will require more effort on the part of the auditor to gather evidence because the quality processes are not transparent. If the auditor is using paper forms and spreadsheets to collect and track data, he or she will need to enter the data into an electronic system after the audit.

After the audit, findings may require corrective action and preventive actions (CAPA) that need to be addressed and managed. Under a manual system, tracking these findings and related documents, evaluating risks, and ensuring proper closure could be a cumbersome process. And that’s just one audit. Imagine the pressures for the company that undergoes several audits involving different parties every year.

5 Tips for a Cooperative GMP Audit

GMP audits are unlike other types of audits. The regulatory requirements for a GMP audit make it more daunting but also necessary and valuable. It’s time to make the process work for you instead of letting it add to your burden. Here’s how:

#1  – Streamline quality processes and increase efficiency through automation.

Automating all audit-related tasks, documentation, scheduling, and planning is half the battle in making a GMP audit a positive experience. Notification, follow-up, and escalation of tasks will also be automatic. All recurring tasks related to audits can be scheduled well in advance. You will drastically cut bottlenecks in the process and improve communication.

#2  – Connect the audit process with the rest of the quality system for a holistic approach to compliance.

Integrate unconnected ERP, PLM, LIMS, CRM, and other systems under a closed-loop platform for a seamless quality management. The integrated system will provide a secure workspace to gather information for audit agendas, cover letters, and checklists. Having one repository for all quality documentation means users and auditors need to go to only one place for everything they need. Connecting the processes, users, and tasks can help prevent siloes among the different teams.

#3 – Increase the transparency of your QMS.

Giving the auditor a real-time view of your quality processes will make that person’s life easier and the process more cooperative. A fully automated QMS with robust audit features and analytics is key to making your system more transparent. It will make the audit process go smoother and faster for everyone. After the audit, the analytics tool will help you generate regular reports to keep the audit findings front and center.

#4 – Promote a change in mindset.

Instill in users that GMP audits are not just a regulatory requirement but a useful tool for continuous quality improvement. Let stakeholders know that auditors are not their enemy. Treat auditors as collaborators in your organizational quest for excellence. Switching from a manual to an automated QMS will make audits easier, and therefore, more positive and cooperative.

#5 Keep your QMS audit ready.

A fully automated and integrated QMS will help keep your processes in order not just during audit time but always. By increasing your audit readiness, you will help remove any adversarial currents in the audit environment.


Audits are embedded in regulations and standards for a good reason. They are meant to help improve quality management. There will always be some things you won’t be able to foresee about an impending GMP audit. But there are many things that you can expect and prepare for well in advance.

Automation can help you keep compliance documentation and quality processes always audit ready. It’s the first step toward turning GMP audits from an adversarial to a cooperative process. It will make audits a more positive experience for your organization and auditors. When this happens, audits will no longer be just another requirement but an opportunity to truly excel.


Read Part One of the Two-Part Series: Remote Quality Audits for Regulated Companies Come of Age

About the Author

Sal Lucido is Co-Founder and Executive Vice President AssurX. Sal is an unequivocal product evangelist and an expert in the area of quality process automation. He holds a broad array of responsibilities, ranging from overseeing strategic plans and operational improvements to managing tactical alliances.