Visualizing a new data-centered quality paradigm. When the first Nokia and Motorola cell phones that were affordable and small enough to fit in your pocket hit the market...
In Episode 4 of this 10-part series, Product Owner Manager Dave Latimer and Principal Product Management Director Terrance Holbrook discuss FDA requirements and how to comply with them.
In Episode 5 of this 10-part series, Product Owner Manager Dave Latimer and Principal Product Management Director Terrance Holbrook talk specifically about how digitizing helps with the complexity of
This publication provides an in-depth look at the FDA’s transformation and addresses how the agency’s initiative will impact manufacturers of regulated products.
Learn about the most common 483 observations and audit findings, and avoid warning letters by staying compliant and addressing issues in the stipulated time period.
The two essential resources regarding the validation of computer systems are: the FDA’s 21 CFR Part 11 and the EMEA Guidelines to Good Manufacturing Practice (GMPs) - Annex 11, Computerized Systems.
MasterControl customer Contract Pharmacal Corporation used to be a paper-based organization. They’ve greatly benefited from switching to MasterControl’s electronic quality management system (QMS).
Medical device managers are complying with FDA requirements and better aligning with evolving industry trends by recognizing the value of moving to a digital quality management system.
The U.S. Food and Drug Administration has released data on the most common observations it makes during inspections of pharmaceutical facilities. This white paper explores the top 10 deficiences.
In the United States, the Food and Drug Administration (FDA) has a number of guidances that are meant to strengthen its oversight of clinical investigators and clinical trials.
This FDA Readiness Toolkit is designed to help medical device manufacturers simplify compliance with FDA standards and streamline quality-related processes.
This white paper provides an overview of the inspection process, describing the preparation for an inspection, what will happen during an inspection, and what to expect after an inspection occurs.
The FDA’s approach to the inspection process of medical device manufacturers, Quality System Inspection Technique (QSIT), embraces a top-down inspection of a firm’s QMS.
The FDA requires medical device manufacturers to report any adverse events to the agency.
After an FDA investigator has inspected your facility and issued a Form 483, it is critical to meet the post-inspection response requirements. Failure to do so can have devastating consequences.