assess a firm’s adherence to established regulations and Current Good Manufacturing Practices.

are internal to evaluate the effectiveness of the QMS.

allow companies to audit their suppliers to assess their quality and compliance with relevant standards and regulations, as the quality of components and materials is critical.

for pharmaceutical sites and data may be required to ensure that trials are conducted ethically and by good clinical practice (GCP) guidelines.

ensure that manufacturing processes are validated, well-documented and consistently producing safe and effective products is a crucial aspect of these audits.

evaluate the effectiveness of risk management systems to identify, assess and mitigate risks associated with the product.

of data management and data integrity practices are crucial, particularly in the pharmaceutical industry, to ensure the accuracy and reliability of data used for regulatory submissions.

for medical devices may focus on monitoring and reporting post-market issues and implementing corrective and preventive actions.

Many organizations manually perform each process required for an audit.

For example, scheduling auditing teams across large organizations typically requires time-consuming phone calls or emails. Auditors in the field often use paper forms and manual spreadsheets to capture data which then must be transcribed into an electronic format for the final report; this reduces productivity and can lead to errors and missed deadlines. Another layer of documentation is added when auditors copy and paste information into rudimentary tracking systems for future trend analysis.

There is no reason to document the same thing multiple times, yet it happens in nearly every life science audit.

Most audits require countless phone calls and emails to schedule, coordinate and bring together the members of the auditor and auditee teams. Follow-up also means many uncoordinated phone calls, emails and reminders, plus manual tracking and tallying of deadlines, status, due dates and delays.

This manual, redundant system doesn’t guarantee 100 percent success. In large organizations, many audits involving many stakeholders take place at any given time, which increases the chance of oversight failure or even audit failure. Worse yet, ineffective communication can give senior management a false sense of security while potentially serious issues are brewing in their organizations.

All too often, organizations invest considerable resources into conducting audits only to find the documentation unusable later. This can happen for a number of reasons; documents may not be stored using the proper procedure or a supplier audit may be conducted at one site and now the results are needed at another.

Regardless of how it happens, poor documentation results in additional risk and, in many cases, rework. It is unacceptable to conduct audits only to have the documentation unavailable for downstream stakeholders, yet that is the very scenario in many organizations.

Each audit may result in numerous findings and related CAPAs that must be addressed and managed.

When all of the elements of an audit program are manual or are not integrated with each other and the CAPA solution, critical information may not be transferred from one process to another in a timely manner. As a result, steps may be missed and required information not gathered.

Lack of integration is inefficient and often creates human error (due to manual transfer of data) which makes it difficult to close the loop and ensure that CAPAs adequately address audit-related issues.

Audit plans can vary broadly based on the type of audit and a variety of situational factors, including the auditor’s training, skills, and experience. Although companies acknowledge that some variation is inherent in the audit process, many companies draft audit plan ‘templates’ to drive more consistent results and ideally create a mechanism to identify trends across audits.

Unfortunately, over time the value is diluted since individual auditors tend to maintain their own local copies of the template and modify them based on their own preferences, resulting in the very inconsistencies the templates were designed to reduce. These inconsistencies can lead to misallocating focus and resources, or worse yet, failure to identify material deficiencies in areas not well covered.

All the previously mentioned challenges—manual processes, poor communication and documentation, lack of integration, and inconsistent processes—lead to an inability to consolidate findings across the global organization and generate actionable reports.

The resulting lack of visibility increases the chance that auditors will be unable to see the bigger picture, including trends and high-risk areas, which can lead to costly problems or compliance issues.

Without accurate audit data, management lacks the information to make sound business decisions.

Voice of customer: Jagdish Meghrajani, Senior Manager IT @ Zydus | Digital transformation journey with TrackWise QMS

“TrackWise helped us to implement all the modules easily along with required IT infrastructures and helped us to harmonize the process across sites.”

Redefining quality audits for a digital world

Quality audits help ensure effectiveness and compliance within the quality system, but today’s digital world requires a different approach.