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Articles written by Martin Browning

Can You Trust E-Signatures From Your Software Package Vendor?

by Martin Browning | Dec 2018

Martin Browning from EduQuest provides insight into the validity of e-signatures from vendors: "Validation must include documentation, or it is not validation. At a minimum, you must establish (note the regulatory meaning of that word) the validity of the e-signatures you want to accept based on you ... Read more »

How to Respond to FDA Inspection Observations, Even Those You Dispute

by Martin Browning | Oct 2018

Martin Browning from EduQuest provides insight on responding to Form 483 observations: "It’s critical to show FDA that you are in control of the situation and are attempting to comply voluntarily by doing everything possible and reasonable to ensure that your products meet Agency specifications." ... Read more »

Understanding the Critical Differences Between Supplier Audit and Evaluations

by Martin Browning | Dec 2017

Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them are nothing more than snapshots in time. In contrast, an evaluation gathers and analyzes data from all kinds of sources, without physical constraints associat ... Read more »

How Often Should You Audit Your Suppliers?

by Martin Browning | Jan 2017

EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, the experts offer Supplier Auditing insight. ... Read more »

FDA Expectations: Overcoming Supply Chain Weaknesses

by Martin Browning | Apr 2014

FDA expectations of supplier management will continue to evolve as pressures are applied to the agency, device recalls are issued and outsourcing continues to expand. To ensure that quality is maintained, it’s important to understand where weaknesses are often found.  ... Read more »

Making Smarter Product Recall Decisions: 4 Critical Steps to Meeting FDA’s Expectations

by Martin Browning | Dec 2012

FDA’s multi-layered rules for product recalls can resemble a double-edged sword. Have you under-reported your recall? Over-reported? How can you find middle ground and ensure compliance? Martin Browning proposes a 4-step decision process. ... Read more »

The View from Washington: What Device Makers Need to Know about FDA’s Latest Strategic Priorities and Initiatives

by Martin Browning | Aug 2011

Agency Announces Five Key Priorities over Next Five Years Continuously hammered by Congress, news media and the international health community, the U.S. FDA has responded with a five-year plan that could have far-reaching consequences for the medical device industry. In late April 2011, FDA Commis ... Read more »