Gregor

true compliance is not just about a tick in a box, it's also about identifying areas for improvement, managing resource more effectively or getting user buy in ........ A quality system should give you a comprehensive system to manage the entire range of compliance and regulatory activities throughout your organisation. Hopefully the system will encourage ownership of your compliance management system, reduce the bureaucracy usually associated with compliance and, crucially, deliver improvement in bottom line performance and the opportunity to advance through your compliance efforts. All of this can be achieved in 7 simple steps:- define and document/ publish and distribute / train and develop staff / verify compliance / capture issues / analyse audits and issues / improve and grow These 7 key steps can make a lasting difference to your organisation and transform the necessary compliance and regulatory activities from a costly overhead into a business benefit with proven competitive and commercial advantage

I currently work with various NHS, Private Healthcare, Medical Device and Clinical Trials consulting on their compliance activities. With a continued focus on the delivery of quality improvements based on the latest evidence based practice and a robust monitoring of performance. One of the key focus is CA/PA management. The company is Gael Ltd http://www.gaelquality.com/healthsector_bloodservices.asp, I am sure if there was enough interest, they would be happy to run through a quick presentation of what they have delivered to date. If this is of interest, please let me know.

Hi Dawn, I currently work with NHS, Private Healthcare, Medical Device and Clinical Trials organisations consulting on their compliance activities. With a continued focus on the delivery of quality improvements based on the latest evidence based practice and a robust monitoring of performance. One of the key focus is managing non-conformance in an electronic format. The company I work for is Gael Ltd, http://www.gaelquality.com/healthsector_bloodservices.asp if you wish to discuss your requirements further, please let me know.

Hi Malcolm, No problem, many of my clients are now using this to prepare for the next inspection! We are currently configuring Q-Pulse to manage the checklist with the example evidence and cross reference to the GMP standard.

Below is a link to what MHRA inspectors are now getting trained on for inspecting blood establishments, there is also a the manual gives valuable information and guidance on the structure of documents related to quality management systems. The content of this manual will therefore by included in the EU co-funded project on developing common criteria and standards for the inspection of blood establishments. http://www.gaelcommunity.com/blogs/quality_news/archive/2010/08/18/revised-mhra-inspection-manuals.aspx

Below is a link to what MHRA inspectors are now getting trained on for inspecting blood establishments, there is also a the manual gives valuable information and guidance on the structure of documents related to quality management systems. The content of this manual will therefore by included in the EU co-funded project on developing common criteria and standards for the inspection of blood establishments. http://www.gaelcommunity.com/blogs/quality_news/archive/2010/08/18/revised-mhra-inspection-manuals.aspx