EtQ Life Sciences Seminar Key Takeaways


On April 24, 2012 I had the good fortune of being able to attend the EtQ Life Sciences forum in Waltham MA. The seminar was focused on presenting best practices in Complaint Handling, CAPA, and Risk-Based Enterprise Quality Management Software. There was a full agenda of speakers, both from EtQ and customers, and in this post I wanted to briefly highlight important insights from several of those presentations for those that could not attend. When our full website launches in several weeks a complete research report will be published in the library on this topic.

Life Sciences

EtQ Technology – Insights from the CTO

The first speaker of the morning was Morgan Palmer, CTO at EtQ. Morgan focused his presentation, not surprisingly, on the investments EtQ has made in the product over the past several years. With the launch of the EtQ Reliance Platform, EtQ now has a modern and extensible technology stack that allows EtQ to build best practices and new modules on the platform. EtQ also now has a graphical user interface that is easy for both users as well as for implementers configuring processes and workflows.

 

Morgan specifically decided to call out enhancements to the platform, that now allow for flexible workflow, reporting, and alerting. Morgan also highlighted the EtQ approach to developing modules which allows best practices and learning from different industries to quickly be introduced to the product. Since the launch of the new platform, examples of these new modules include Operational Risk Management, EH&S, Food Safety, and more. The final points Morgan made were around interoperability. EtQ understands that they operate within an IT landscape that usually includes very large players that companies have made enterprise commitments too, like SAP and Microsoft. In both cases EtQ has built direct connectors to SAP and Microsoft SharePoint, and in the SAP case, EtQ is now a certified partner.

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Enterprise Quality Management Software: Understanding how Systems, Process, and Technology Interact

The other speaker I wanted to discuss was Kenneth Ray, Director Quality Systems and Continuous Improvement at Celegene. Kenneth is a veteran of the Quality Management space, having worked for multiple pharmaceutical companies in leadership roles over the past 20+ years.  Kenneth's presentation focused on the many interdependent quality and regulatory process that must be effectively managed in a large pharmaceutical company. His keys for success in managing these are strong governance processes to manage inter-departmental issues as well as a management approach that empowers decision makers with clear guidelines and support rather than unclear guidelines and the undermining of manager decisions by more senior executives.

On the technology side, Celegene has been a client of EtQ for 2.5 years and has gone through an exhaustive selection process to choose EtQ as the corporate standard. In the case of Celegene, having a corporate standard is critical given the acquisitive nature of the company and goals for growth. Over the next 2 months, Celegene plans to go live with 8 modules, many surrounding typical quality processes like NC/CAPA and Complaint Management. Much of the focus of the implementation has been on supporting the inter-connected processes and governance issues that Kenneth believes are so critical for success.

Kenneth also stressed that in any EQMS implementation it is almost always better to get a system up and running quickly and then improve and expand it over time. Kenneth believes getting up fast with 80% functionality now and iterating is better than getting 100% of functionality at some uncertain time in the future.

Concluding Thoughts

Although the large pharmaceuticals and medical devices spaces is relatively new territory, EtQ has momentum on their side right now. It will be interesting to see if EtQ can maintain this momentum and continue to grow and scale with these companies over time. When trying to assess the long term potential of EtQ in the large life sciences space; how these current implementations, like Celegene, fair over the coming years will go a long ways to determining future success. For continued coverage of the EtQ and the entire Enterprise Quality Management Space, please visit the LNS Research blog and website often.

If you would like to read more on the topic of quality management, please click the button below to become a part of our community and gain access to our Quality Management Systems Research Library.

 

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All entries in this Industrial Transformation blog represent the opinions of the authors based on their industry experience and their view of the information collected using the methods described in our Research Integrity. All product and company names are trademarks™ or registered® trademarks of their respective holders. Use of them does not imply any affiliation with or endorsement by them.

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