ISPE GAMP CoP forum review

Services Director, Chris Owen, recently attended the International Society of Pharmaceutical Engineering's (ISPE) Good Automated Manufacturing Practice (GAMP) Community of Practice (CoP) forum. Below, Chris has shared his review of the event.


  Chris O and Mike P




Why did you attend the event? 

GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. It is a technical document which describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500.

The ISPE GAMP CoP events are the perfect learning environment for Qualsys. Our company develops and implements governance, risk and compliance management system software for heavily-regulated companies such as Sodexo and Iovance, so it is essential that we are at the forefront of any industry changes, developments and pre-empt challenges. 

At the CoP events, speakers from across the industry share research projects, personal experiences and challenges. This enables Qualsys to hear different opinions and scan the horizon for new opportunities, as well as provide reassurance that we are meeting industry best practices. 

Culture of quality

What was your favourite part of the day? 

The speakers were all very knowledgeable. One of the talks which I found particularly helpful was "Audit Trail & Audit Trail Reviews in Practice" by Reetu Chopra from TEVA. Reetu shared how there is an overwhelming lack of confidence when it comes to audit trails for compliance.

MHRA auditors are increasingly wanting to pinpoint why something happened using audit trails, as well as what, where, who and how. Our audit trails meet the highest regulatory compliance standard, and configurations have been approved as compliant with MHRA and FDA. Therefore, Qualsys will continue to develop our audit trails in our product road-map to make them an even stronger, more valuable tool. 

 Audit trail


What were the hot topics?

With the recent launch of the General Data Protection Regulation, the spotlight is on Privacy by Design and managing processes horizontally. However, there is still a lack of understanding and knowledge around GDPR, data integrity and the benefits of integrated systems. 

For Qualsys, this implies we need to provide more guidance and expertise in a wider sense. We have broad knowledge and experience in integrated management systems, so we need to demonstrate how processes can be managed horizontally. 


GDPR toolkit


Who would you like to see speak again? 

All the talkers were engaging and shared interesting perspectives. Anders Vidstrup from NNIT stood out to me. He was particularly energetic and enthusiastic and we’d like to collaborate more with him in the future on quality versus security. 


Key lessons learned?

The pharmaceutical industry is continuing to invest in new technologies to improve efficiency, resilience and identify risks. A key trend is that companies want partnerships where the vendor manages more of the management system, such as Infrastructure as a Service (IaaS), Platform as a Service (PaaS) and Software as a Service (SaaS). 


What to do now: 

Learn more about upcoming GAMP CoP forums here: 

Alternatively, find out more how Qualsys's software helps implement integrated life science management systems here:

Gxp compliance software


Topics: GxP Pharmaceutical Regulation, GAMP, News, GXP

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