<span class="archive__title-prefix>Posts Categorized:</span> Blog

At the PDA Annual Meeting in late March 2024 in Long Beach, California, Redica Systems CEO Michael de la Torre presented a vision for how artificial Intelligence (AI) can reveal enforcement trends in data integrity inspection findings and the work his company has done to date to realize that vision. He began by referencing a […]

A pilot between three drug regulators aims to target aspects of good manufacturing practice (GMP) inspections to include better coverage of what each regulator would like to see evaluated. A feature of this pilot not common to most Mutual Recognition Agreements (MRAs) is a planning phase to ensure the regulator performing the inspection covers the […]

FDA has discovered a direct, causal link between a multi-state outbreak of antibiotic-resistant bacteria in 2022 and specific contaminated eyedrop products. The agency’s labs determined a “close genetic match” of isolates taken from eyecare product samples to clinical isolates from patients who used the eyedrops and suffered infections. Samples of an antibiotic-resistant strain of the […]

Updated December 2024 Introduction to the MAUDE Database The FDA regulates a wide spectrum of healthcare products, ensuring that medical devices, pharmaceuticals, and other health-related goods entering the market meet stringent standards of quality, safety, and efficacy. Central to this mission is the FDA’s Manufacturer and User Facility Device Experience Database or MAUDE. What is […]

Do you know the difference between remote/virtual and hybrid GMP inspections and which may be applicable to your facility and situation? At the 48th annual International GMP Conference held in early March 2024 at the University of Georgia in Athens, Georgia, Health Canada Acting Associate Director of Health Products and Licensing Divisions Teresa Forlini explained […]

A new memorandum of understanding (MoU) between Canada and Australia provides that each country will officially recognize good manufacturing practices (GMP) inspections conducted outside of their respective jurisdictions and provide Certificates of GMP Compliance (CoC) valid in both countries. Facilities and inspections outside a jurisdiction are known as “extra-jurisdictional.” Only onsite inspections will be recognized […]

Any hiccup involving life sciences contractors and vendors can have major reputational, regulatory, and legal repercussions — and outright fraud and theft do sometimes happen. How can life sciences companies mitigate these concerns and even protect themselves? BrownRudnick partner Merri Moken and consulting attorney Mark Paxton recently visited the virtual Redica Systems studios to help […]

This is the first in a series of posts based on a Redica Systems webinar featuring Ulrich Köllisch and Peter Baker in a wide-ranging Q&A on the multi-step process for reaching what they call “quality intelligence.” Briefly, quality intelligence (QI) itself is a program of risk and data management that they see as an absolute […]

Since 2010, FDAzilla.com has helped thousands of people easily access FDA Form 483s, 483Rs, and EIRs. Our document store repository helped teams like yours get data quickly and efficiently without going through the laborious and slow FOIA process. Today, we’re happy to announce that we’ve begun transitioning the fdazilla.com document e-commerce store to redica.com/document-store, where […]

“Data is the new oil” is a phrase attributed to British mathematician Clive Humby in 2006. While data has undoubtedly become one of, if not the most, important currencies of the modern economy, there are enormous differences between good-quality data and bad-quality data. Bad-quality data has negative value. It can mislead. It can overwhelm and […]