Often, companies find themselves inundated with open CAPAs. This is most commonly experienced in the aftermath of an audit, where the CAPA system is used to document the issues that are identified, the investigations, the execution of corrective and/or preventative actions, and finally the closures.
Purpose This White Paper reviews the proposed changes to Annex 15 of the EU GMP guide in detail. The draft of the revised Annex 15 was released in February 2014 by the European Commission. The draft version is based on an EMA Concept Paper that was published in November 2012. A review of the Concept…
You have a great idea to save water and energy in the facility. The engineering changes required for capturing savings are straightforward, but if the changes will impact a GMP system, the effort becomes more complex and may have a large financial impact.
March 1st 2014 will see the newest revision of the PIC/S GMP Guide (PE 009-11) come into effect, replacing the previous version PE 009-10 that has been current since January 2013.
PharmOut is proud to be part of the 2014 ARCS Australia Scientific Congress as a major sponsor. 3 – 4 June 2014, Australian Turf Club, Royal Randwick, Sydney.
Congratulations to Ian Yinfoo from NSW, Australia. Winner of the 2013 GMP Quiz draw and will be receiving a brand new Apple iPad Air from PharmOut on behalf of our Online GMP Training team. Thank you to all those who completed the Online GMP Quiz and submitted their score. We have had an exceptional response…
This paper reviews the principles of risk management in software development of GxP systems, elaborates on the well-known risk management approaches and identifies some of the important concepts of proactive management of risks throughout the software development lifecycle.
This paper reviews the implementation of the ANSI/AAMI/IEC 62304 Medical Device Software – Software Life Cycle Processes standard.
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