Redica Systems

Quality Assurance professionals at life sciences companies have a challenging time gathering and structuring the data they need for analysis. ? There are too many sources and too many different structures. ? Now you can get it all from one place, neatly structured so that you can spend your time on high-value analysis rather than data hunting and wrangling. Reach out to us if you'd like to see a demo customized to your company. Sam McDonald and the team are ready to help you move to proactive inspection readiness rather than reactive.

We're excited to exhibit at the Regulatory Affairs Professionals Society (RAPS) Regulatory Intelligence Conference in Baltimore starting tomorrow! ?? ?? Stop by our booth to meet the team — we’d love to chat! #RAPSConvergence #RegulatoryIntelligence #LifeSciences #Medtech

Artificial intelligence (AI) and machine learning (ML) are transforming industries, but what does it mean for GMP compliance? Join our upcoming webinar for a structured look at key concepts, risks, and real-world applications. What you'll learn: ? Foundational AI/ML principles in GMP ? How to assess risk and validation challenges ? Practical use cases shaping the industry ??? Register here: https://bit.ly/AIMLinGMP

[NEW BLOG POST] When a Health Canada ???? inspector shows up at your drug manufacturing facility, what are the probable inspection targets? What areas are likely to be focused on, and what are their expectations? How does Health Canada differ from FDA is these respects? https://hubs.la/Q036RHJ90

?? We should keep our eyes on the ball: safe, effective, available, and affordable medications for all. ?? We originally published this to our blog, back in November, right after the U.S. election. While much has changed for FDA since, and much change is likely still to come, our recommendations for fixing some of the agency's biggest challenges remain the same.

A couple recurring questions I have gotten over my many years in the pharma industry are, "What is a 483 and what do I do if I get one?"?and, "What happens after a 483?" Here is the high level process showing key agency inspection and enforcement actions in increasing severity from left to right. A thorough and thoughtful response to a 483 shows FDA that the company understands the issues raised and takes their remediation seriously. A good response can make the difference between escalation to a warning letter or not. Similarly, the response to a warning letter and the diligent completion and documentation of requested action items helps determine the trust level the agency has in the firm and whether further enforcement actions may be needed. In situations where injunctions (consent decrees) are involved, fines in the tens to hundreds of millions of dollars are common and the damage to the firm's reputation is immense – not a place you want to find yourself. And remember that in extreme cases company officers and executives may be personally liable.

We're excited to publish this first issue of the LinkedIn version of The Signal, our newsletter. We'll publish new issues 1-2 times/month, featuring some of the best content from our blog. Be sure to subscribe! And if you'd like to collaborate on future issues, let us know!

Join our CEO, Michael de la Torre, at this free, hands-on event ???? ???????????????? ??????, ????????, 8:30?AM - 5:30?PM at the Innerspace - The Simulator Company VR Symposium at Open Biopharma Research and Training Institute, Carlsbad, CA. ???????????????? ??????:?https://lnkd.in/dmKzgG95 He'll be presenting on "Recent Inspection Trends for Aseptic Issues", demonstrating Redica Systems data. ???????? ?????? ???????? ??????????: ?? How a leading biotech company resolved training gaps by implementing VR into its SOPs. ?? Strategies to avoid and overcome FDA warnings related to training deficiencies. ?? How VR helps to prevent common cleanroom errors and achieve ROI within 12 months. ?? How training supports and standardizes your QMS and LMS. ?? How VR training shapes aseptic behavior prior to actual cleanroom operations. ?? Why effective training is essential for ensuring patient safety. ?? How VR training boosts operational efficiency, budget performance, and overall facility effectiveness. Looking forward to presenting along with: Richard (Rick J Nash) Jaenisch, MPH, Chuck Gagnon, Michael Fitzpatrick, and Binh Nguyen.

During a March 2024 inspection of a finished drug company in China, FDA investigators Brandy N. Lepage and Karen A. Briggs encountered company management that limited access to manufacturing areas, disallowed photography, and supplied fewer documents than requested, many of them heavily redacted. The Redica Systems model identified 19 major deficiencies and two minor ones across four quality systems from a five-item, four-page 483. While this analysis of the 483 paints a picture of a company with major issues across four quality systems, viewed in isolation, it would not seem to solidly predict a warning letter, especially since no critical deficiencies were identified. However, as shown by the additional detail in the warning letter, the 483 does not tell the entire story of the inspection, a valuable lesson for those who analyze inspection documents. https://hubs.la/Q034nX3x0

A recent analysis of our data found that out of 72 inspected sites that had received warning letters, 59 (82%) had been cited for CAPA, and many also struggled with related areas like complaint handling and nonconforming product controls. In this guest post, Jackie T. from @qlearadvisors shares some actionable advice on how to improve your CAPA. https://lnkd.in/g_zK_R-V