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Deviation Management Tips for the Digital Era

Life science professionals working on deviations resolution using a digital eQMS.

What an amazing experience it was to attend and speak at Masters Summit 2023! I was able to meet many wonderful digital quality management professionals and representatives of companies that work with MasterControl and support their missions around the world. I attended the keynotes and other breakout sessions being presented by fellow colleagues, and I was very impressed with the entire conference, but especially with the individual sessions and presentations. I was able to take away a treasure chest full of valuable information and made a few new friends along the way. My presentation, “Business Leadership: Minimizing and Managing Deviations in Your Manufacturing Setting,” was held on the afternoon of Wednesday, Oct. 18 and was very well attended. Thank you to all the MasterControl staff and friends for making this a memorable experience.

Deviation Management Takeaways

One of the first takeaways I had from my interactions with individuals in the quality area was just how “hand wavy” regulatory compliance standards, especially around deviations and deviation management, seem to be for the common manufacturer. Yes, deviations can seem to be less of a black and white and more of a gray area, but there are some very clever and effective ways to make this less so.

The first way we talked about was how to harness MasterControl’s electronic quality management system (eQMS) solution utilizing artificial intelligence (AI) technology to build in flow charts and value questions that can guide individuals in real time as to if what has occurred as an error is indeed a deviation. Since its quite common for manufacturing to be a 365 24/7 pursuit, there isn’t always a quality assurance (QA) professional to call if an error occurs at 2 a.m. This is where a robust eQMS system with very easy-to-navigate questions and steps can save time. Most importantly, it also maintains a quality environment for production when a possible deviation occurs.

The Importance of eQMS Accessibility

One of the more important ideas of keeping an all-electronic management system is that it can be accessible from anywhere in the world via a portal. There was a poignant comment made early on at the Masters Summit that a few of the companies represented there were just visited for an audit by the U.S. Food and Drug Administration (FDA). You could hear the gasps in the room; however, the individuals were not worried because any issues that came up quality-wise were only a login away from their laptops to view, see, send, and approve any deviations or questions about deviations. This type of peace of mind was very refreshing to see. Knowing that their eQMS systems were working and accessible anywhere hit the point home that in this fast-paced world, we need to be flexible and MasterControl can provide that via its eQMS system. I had an excellent audience, and their questions were very thoughtful and investigative.

Deviation Management Next Steps

When I returned home after a full week immersed in Masters Summit, I started to think about what else MasterControl could do for deviation management and compliance. I believe the integration of AI will be a “game changer” in the way we think and interact with our eQMS systems in the pharmaceutical space. The AI technology demonstration at Masters Summit showed how a user-friendly, out-of-the-box product will make even the most junior of staff feel like QA superheroes when it comes to deviations management by providing easy-to-use tools and prompts that will streamline workflows and decrease time spent on deviations tracking and management. Everyone I spoke with at Masters Summit was excited to see how the AI programming will help their digital quality management and foster a culture of quality improvement at their companies.

As a quality professional, I really understand how deviations and other issues can be very daunting to not only start but track and manage appropriately. In my presentation, I tried to break down this very big concept and put it into a bite-size, easily digestible form with easy-to-follow diagrams and flow charts. The concept of thinking of the deviations management big picture and getting “visual” with directions rather than using words was a huge “aha!” moment for some, and this is where MasterControl is leading the way — by making hard things easy, even deviations.

Erika Roberts headshot

Erika L. Roberts, M.F.S, obtained a Masters in Forensic Science in 2006 (with an emphasis on document examination) and currently works as principal consultant and owner of ELR Lab Services LLC. Having over 15 years of experience working in many different areas of the pharmaceutical/biotech manufacturing quality environments, Ms. Roberts is uniquely qualified as a subject matter expert for sterility testing, microbial identification trainings, HPLC analysis, and cGMP training topics. Her extensive background in pharmaceutical regulations and applications allows for a broad perspective and a depth of training not commonly found in the industry. In addition to her microbiology and analytical chemistry work, Ms. Roberts is also a qualified trainer for document reviews of several chemistry analyses commonly used in many FDA-regulated laboratories.

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