The New Life Science Solution and its Implications on Document Management for Pharmaceutical Companies by Dr. Gerhard Neurauter and Dr. Olaf Schoepke EXTEDO

The European Medicines Agency (EMA) recently announced a new pharmacovigilance legislation, describing how to modernize its pharmacovigilance system, how to improve patient safety and how to supply health information to patients. Considering the consequences on information management and business process, pharmaceutical companies have a very short timeline in which to adapt to and implement the initial phase. The attempt to define and establish the "Identification of Medicinal Product (IDMP)" standard as a global harmonized electronic exchange format seems to be the biggest change in the regulatory registration process today. How agencies and pharmaceutical companies can address this new legislation along with the respective consequences for their data management is described in this article.

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What to Expect When They're Inspecting - Part II by Holly Scott Biologics Consulting Group, Senior Consultant and Former CBER Consumer Safety Officer and FDA Field Investigator

The first segment of this series focused on some of the non-traditional variables that can have an effect on any FDA inspection and how to achieve a positive outcome regardless of the inspectional conclusion. That article generated some blog discussion on FDA's objectivity. I wanted to clarify some of those issues. FDA investigators are trained to be objective in all situations and will approach their inspection in this manner. However, firm management needs to understand that when intentional barriers to an effective inspection are presented or the FDA Investigator is met with a less-than-cooperative attitude, the realistic conclusion is that management is trying to hide objectionable GMP conditions, leaving the Investigator no choice but to be even more thorough to ensure there are no safety or quality risks to the consumer. It isn't that an FDA Investigator is showing bias or being subjective, they're "Investigators" - it's their job to do so.

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Annex 11: The EU's New Expectations for Regulated Computerized Systems by Martin Browning President and Co-Founder, EduQuest

In 2011, the European Union (EU) revised its guidance for the life cycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. The guidance, called Annex 11, also was revised in response to an alarming number of problems detected in computerized systems.

Annex 11 is one of several guidance documents that supplement the EU's GMP rules (EUDRALEX Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice). It applies to all human and veterinary medicinal products made or sold in the EU.

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