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  • Data Integrity: A Return to Basics

    20 十二月, 2017 By Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl

    Since the U.K.’s Medical and Healthcare product Regulatory Agency (MHRA) (1) and the U.S.’s Food and Drug Administration (FDA) (2), published on this subject in 2015 and 2016, respectively, data integrity continues to gain importance as an issue. Some workshop participants wondered if this is simply a new trending topic that will quickly fade. I firmly believe that it is not.

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  • Revisiting CAPA for a More Modern (and Effective) Approach

    17 十月, 2017 by Peter Knauer

    Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?

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  • Free Webinar: What the New European Med Device Regulation Means

    22 六月, 2017 Cindy Fazzi, Staff Writer

    The European Parliament recently adopted a stricter, more extensive Medical Device Regulation (MDR) to replace the Medical Device Directives (MDD). It will affect all manufacturers selling devices in the European Union. What does the new regulation mean for device manufacturers? Will it make life harder and increase costs for them?

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