(Case Study) Multi-national Biotech Companies Employ New Technologies to Streamline Critical Processes

Two international biotech companies leveraged each others successful audit management experiences to improve their own. Audit readiness became an important focus for the Quality department of a multi-national vaccines and diagnostics company.

Crucial to their audit readiness plan was leveraging technology for audit preparedness.  In analyzing their current processes and systems employed, the QA Director became aware that their current audit readiness plan, a paper-based system for managing regulatory and internal audits and an online chat system, was time consuming, inefficient and unproductive.  Without an improvement in the information flow, they would continue to be dependent on skilled, valuable people to orchestrate the process.

The director of Quality decided that it would help her department greatly to employ technology to automate their paper-based audit management system.

In a bold move, they decided to implement Audit Utopia™ as a hosted solution, an application which had been standalone for several years but one that had recently been made available as web-enabled solution.

This decisive move has proven a valuable component in the overall audit readiness strategy and policy which has been adopted by this busy Quality Assurance department.  In a very short time, they have transformed from audit panic to being awarded the Quality Operations Award for Inspection Management within their organization.

In addition, they received positive feedback from both FDA investigators as well as internal auditors; commenting on the proactive and professional manner that the audit team handled the investigation as well as the image of preparation and efficiency they projected.  This feedback did a lot for the morale of the audit team as positive feedback from auditors is, as we all know, sometimes hard to come by.

This QA Director attributes implementing Audit Utopia™ in conjunction with their strategic audit readiness plan with:

  • Reduction in observations per inspection day by nearly 40%
  • Reduction in request entry and tracking time by 80%
  • Reduction in agency observations by 82%

These results are both qualitative and quantitative and above all of great value to organizations seeking to proactively address the trend of fewer, but more comprehensive audits.

Likewise, a Sr. Associate Director for QA Compliance at an international, chemical and healthcare company wanted to change their manual methods of handling audits.  This director realized the time saving and stress reducing benefits possible by automating the audit request process.

Streamlining Benefits:

  • Centralization of Information
  • Organization of Audit Request
  • Communication system built-in
  • Integrated Reporting
  • Time-saving / Resource friendly

Their current methods worked well, but required forms in triplicate, extensive use of email and an online chat.  This “system” was manageable when they experienced smaller or internal audits where the audit team could easily manage a low volume of information requests.

However, during FDA or other regulatory audits involving multiple auditors making hundreds of requests over weeks, the ability to coordinate efforts, respond effectively, organize the information and keep their team stress level in check became a daunting and exhausting task.  After seeing firsthand the benefits reaped by employing Audit Utopia(TM) at another company in the area, along with mandating an audit readiness plan, he decided that his department could reap the benefits as well.

Although the transition to an automated system was greeted with some skepticism that typically comes with a change in processes, his team quickly realized the benefits of the new system.  They also found the transition painless as the system was so easy to use.

Since their implementation over a year ago, they have seen their ability to handle complex and intense audits, such as a recent agency audit which generated hundreds of requests for information.  Through this experience, they realized that by implementing the Audit Utopia ™ software, they have reduced the time spent by their audit team by at least one hour per person per day.  Rather than spending team time administrating & checking requests, they can spend their time effectively planning their responses to requests, leveraging their resources and simultaneously coming off as an organized and highly functioning group to the auditors.

They have been able to streamline their end-of-day summary from hours of note comparing to a short time reviewing informational reports.   They have truly reaped the benefits of fine tuning their organizational format with the benefit of producing less down time and ultimately less stress.  This QA Director mentioned that he did not know how they would have handled such an intense and prolific inspection if they had not had Audit Utopia™ to help them manage the inspection.

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