Shaping the future of quality at the RQA Virtual European QA Congress

"Transformation is a dramatic change. It is an alteration. It is not doing the same thing we did thirty years ago but now using a computer."

Sparta Systems, a Honeywell company, was proud to be a platinum sponsor of this year’s Virtual European QA Congress, held on May 11-12. This 2-day event was focused on uniting and shaping the future of quality by sharing how innovation and collaboration have sparked the world of life science. 

The event brought together speakers from over 10 countries who have the common belief that we are better together. 

We all understand that the life sciences industry is experiencing rapid growth and regulatory complexity. The COVID pandemic has brought out big shining neon lights and placed them around the importance of science, technology and innovation. 

In today’s market if you want to succeed you must embrace both “digital” and “transformation.”  

Leaders seem to understand the digital part but our failing tremendously on the transformation side. 

It is important to remember the definition of transformation—transformation is a dramatic change. It is an alteration. It is not doing the same thing we did thirty years ago but now using a computer. 

Industry 4.0 is the state of digital transformation and 4.0 will leverage big data, the industrial internet of things, and AI (Artificial Intelligence) with real-time actionable data generation to analyze, solve and enable smart decisions. It uses technology to transform business processes and culture, envisions new business models, and delivers value to customers. 

And making data actionable—with insights to power both human decision-making—and real-world automation is driven directly at the edge. 

This is the key to our future. 

All these needs are fueling a wave of digital innovation across our industry. RQA provided a forum to collaborate, educate, and to share how we can harness data and digital to move our industry forward and accelerate with Quality 4.0 through connected life sciences. 

Over the course of 2 days this conference dove into: 

• GCP theories, practices, and remote audits 

• Virtual compliance training 
• Vendor selection and oversight, remote working 
• Inspection readiness, MDR and IVD, quality compliance, writing SOPs (Standard Operating Procedures), six sigma, challenges of RA professional 
• The requirements of the clinical phase, practical quality management system (QMS) in clinical sites 
• Risk-based approaches, proactive corrective and preventive action (CAPA)  

• Understanding Part 11, data integrity, cyber security, and audit trails with digital technology. 
• Future—QbD (Quality by Design), design of experiment, internal quality audits 
• The importance of quality culture   

This event provided fresh insight and innovative ideas into the future of quality. We are in the right place at the right time to build partnerships and collaborate with peers in the life science industry. 

I also had the opportunity to present the topic, “Re-Defining Quality Audits for a Digital World.” During this session, we discussed the benefits of taking a digital approach to internal quality audits, common barriers to effective audits, and how you can overcome those challenges. 

This was a fantastic event. Readers, I hope that you will all continue to be innovators and embrace innovative technologies that will improve patients’ lives, not just today but in the future. 

We’ll be talking more about these innovative technologies at Sparta Connection from June 6 –9. I’d like to invite you to join us there and continue the conversation around tools that continue to shape the future of quality.