by Emily Hill

ISPE GAMP Forum increasing dialogue in Pharmaceutical Regulation

Qualsys recently attended the International Society for Pharmaceutical Engineering (ISPE) GAMP Forum, an event organised to increase dialogue and practical guidance between those involved in pharmaceutical regulation.

Michael Ord and Ben Saxton both attended the event to further their Pharmaceutical sector knowledge and understand the issues many of our clients face. As a vendor organisation we were pleasantly surprised and grateful of the open culture and welcoming nature of the forum.

Common issues within pharmaceutical compliance were shared with other members of the forum with a shared goal of improving practice for all. The November event was held at the recently opened and incredibly impressive Waters Mass Spectrometry facility in Wilmslow. The facility is an inspiring space to hold a forum and all delegates enjoyed the fine catering provided.

WW

The forum consisted of a number of presentations all delivered by an expert of their field as well as break-out sessions where a number of different topics were debated.

Trevor Simmons of ZigZag started events with a thought-provoking presentation on the use of Cloud solutions. We were all in agreement of the advantages that Cloud could offer but definitions are required around what “Cloud” refers to with Open Clouds, Community Clouds and Private Clouds all available to organisations. Trevor stressed the importance of being aware of the need to control where our data resides, especially if you need to conduct data destruction at any time.

Chris Reid of Integrity Solutions updated the forum on the ISPE special interest groups including mobile apps led by Sion Wyn of Conformity, the result of which is the ISPE GAMP Mobile best practice. This discussion may have been aimed at addressing issues faced by mobile apps designed for the general public more than the corporate world but was still of great interest to ourselves. Our iEQMS Auditor App for the iPad is in general use by a great number of our clients including those who are FDA regulated.

Sion Wyn

John Andrews of Integrity and Heather Wilkinson from GSK hosted an open floor discussion on regulatory intelligence in which the need for electronic signatures, the FDA being able to take pictures on site and audit trail were all raised. We have been developing a complete audit trail solution to live within EQMS for some time and the points raised within this discussion were reassuring to hear from such an audience.

We attended the round table discussion, focussing on how to select a suitable partner organisation when outsourcing key functions, while as a group we exploring how such a critical relationship is measured. It’s hard to give a definite answer for this but a mixture of well-designed metrics and the less quantifiable ‘how well do they deliver this service’ appears to be the best measure.

"It was enlightening to spend the day with Quality professionals from the Pharmaceutical world, sharing ideas and best practice during the round table break-out sessions. As a supplier of an audit manager application currently in place within the pharmaceutical industry, the final presentation on the use of Mobile Apps within the industry was very interesting and has started numerous new product discussions within our organisation."

- Ben Saxton, Qualsys' Business Development Manager

Qualsys value the continous personal development of their staff as well as ensuring EQMS is developed to provide a solution to the challenges faced by both prospective and existing clients alike. The ISPE GAMP forum helped deliver on both of these points. For a more in depth report or to receive a demonstration of the iEQMS Auditor App please contact Ben or Michael on 0114 282 3338

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Tags: Software, Events, FDA, GxP Pharmaceutical Regulation, GAMP