October 2011 Posts

Are You Ready for the EU’s New e-Labeling Rules?

Mark Crawford

In June 2011 the European Commission released a draft regulation on e-labeling (http://ec.europa.eu/enterprise/tbt/). The comment period is over and the final version is expected to be adopted on December 14, with activation starting in March 2013. This gives medical device companies about a year to catch up on the details—of which there are many. (more…)

Will the Medical Device Regulatory Improvement Act Be a Game-Changer?

Mark Crawford

Three years ago the FDA enacted tougher measures to reduce the potential conflicts of interest for medical device experts advising the U.S. Food and Drug Administration (FDA).

Claiming that these rules are strangling the timely advance of new medical devices to the market, U.S. Senators Amy Klobuchar (D-Minnesota), Richard Burr (R-North Carolina), and Michael Bennet (D-Colorado) have introduced the “Medical Device Regulatory Improvement Act” in an effort to streamline the FDA regulatory process. (more…)

Beware: Annex 11 Has Implications for Medical Devices

Beware: Annex 11 Has Implications for Medical Devices

Mark Crawford

In January 2011 the European Medicine Evaluation Agency (EMEA) released an updated version of the European Union’s GMP Annex 11 for computerized systems (Annex 11), as well as an expanded version of Chapter 4 on document management.

These are significant changes for the pharmaceutical industry—the new Annex 11, for example, is about four times larger than the older version. EMEA decided to overhaul Annex 11 to keep up with the increased use of computerized systems in all aspects of good manufacturing practice (GMP), as well as their increased complexity. Annex 11 now addresses the regulatory needs of modern IT systems and imparts extensive requirements for compliance at all levels—for example, it dictates how computer printouts of critical records must indicate if any data has been changed since the original entry. Other key topic areas include business continuity, incident management, electronic signatures, migrating and archiving documents, and more comprehensive security controls. (more…)

Root Cause Analysis and Human Factors

Mark Crawford

In its new white paper, “How to Reduce Human Error by Managing Human Factors,” the FDA indicates the “typical response to a human error is retraining. But studies have now shown that training —or lack thereof—is responsible for only about 10 percent of the human errors that occur. Despite [an increased] awareness of human errors, companies still frequently fail to substantively and correctly address errors.”

Companies often turn to training, or retraining, as a quick and easy solution for a human error, when the real cause may be a deeper, systemic issue that could be revealed through root cause analysis (RCA). (more…)

Could Your Quality Systems Protect You in a Court of Law?

Mark Crawford

Quality system management and documentation contain a wealth of information (or lack of) that can be used by a regulatory agency like the FDA or a plaintiff in a lawsuit to determine if the company is in compliance with federal regulations or its own internal quality management procedures. Failure to meet these requirements can be highly damaging to a company in litigation.

“Quality manuals and quality system documents are intended to guide the operation of a company’s quality management system, says James Kolka, president of Kolka & Associates in Atlanta and an international legal consultant in regulatory affairs. “Quality system documents are neither intended nor constructed to provide evidence of a company’s concern for patient safety and product safety. If a company wants to prove it cares about patient safety and make safe products, it must build documentation to prove that point.” (more…)