Markus Roemer, in Stuttgart, puts order in the GXP regulatory landscape

Stuttgart Summit: Highlights & takeaways on how to validate software development tools for GXP and MedDev

Posted on Posted in Blog, Confluence, Electronic QMS, JIRA, Validation microsite

Last week a select group of 15 health sector professionals representing businesses from startups to large pharmaceutical companies gathered in Stuttgart, Germany for expert insights on implementing and maintaining effective quality systems. Featuring presentations by four industry leaders, attendees left the conference with actionable information – regardless of if they were initiating a new system or improving an existing one.

Given the focus on QMS sustainability and overall efficiency, the presenters illuminated their points with real-world examples of systems that are compliant but not excessive, are proportional to the clinical safety risk, and that use software and infrastructure to effectively lessen the burden of compliance.

Presenters included:

  1. Ott Stellan, CEO of ott+partner: Stellan presented a compelling look at his company’s transformation from a cumbersome and wasteful paper-based quality system to a functional digital system using the Capability Maturity Model Integration model (CMMI) as the guideline for the quality processes, and a Microsoft team foundation server as the electronic platform for their project work. Along with a significant reduction in waste and increase in efficiency, the company culture also underwent a dramatic shift – for the better. As a supplier to pharmaceutical companies, ott+partner is audited frequently and their new processes have helped them consistently pass audits with flying colors.
  2. Rina Nir, CEO of RadBee: An expert in implementing quality processes in Jira and Confluence, Nir explained the many benefits of using these platforms to reduce friction with quality processes and increase staff engagement and efficiency. She also provided three case studies using these Atlassian tools to support quality processes, showcasing how to use Confluence for controlled documents and JIRA for Corrective and Preventive Action (CAPA) management and to support Software Development Life Cycle (SDLC) and an eValidation approach.
  3. Markus Roemer, CCS Consultant, demonstrated how he used Confluence to support SDLC and traceability. Despite a difficult start and a reluctant team, the system he devised and implemented was eventually overwhelmingly adopted and has now stood the test of time, successfully passing numerous audits over the last several years. Additionally, Roemer also provided an overview of regulations and standards that impact the industry, highlighting especially prevalent misconceptions and how some companies evolve a nonsensical and excessive set of processes.
  4. Keith Williams, CEO of C3, gave guidance around the various infrastructure options available to businesses as the cloud becomes mainstream in GXP environments. From “on-premise,” to “hosted,” “private cloud,” and so on, he discussed the costs, benefits and risks that each option presents. Because there’s no one rule that fits all, Williams emphasised the need to avoid excessive spending, and advised companies to instead to seek out the fiscal and efficiency sweet spot where the compliance and quality strategy aligns with the patient and business risk.

Key takeaways from the conference included:

  • The importance of finding the optimal point between doing too little and too much when it comes to implementing quality processes.
  • How Jira and Confluence support effective QMS management, and why these tools are so engaging to users.
  • Why moving an ineffective paper system to an effective eQMS using SDLC tools and eValidation is very achievable – as long as timeline expectations are managed.
  • How a sound process to follow before implementing a new QMS involves setting your own risk approach, challenging it, and then getting input from the quality, business and compliance owners. From there, it’s essential to prototype and test to be sure it accomplishes all key goals before company-wide implementation.
  • Why to ensure sustainability, it’s essential to first agree on what you need to do for quality and regulatory compliance in your business, then transparently track the processes. By continuously challenging those processes and measuring the performance, your system will dynamically evolve and improve.

Attendees delighted in seeing examples and receiving knowledge from different viewpoints and were particularly enthusiastic about real use cases. They also noted how enjoyable it was to be a part of this “friendly group” and appreciated the detailed insight into what must be done for compliance sake – and what’s excessive. The conference also revealed an important “need” to further discuss issues of “sensible approach to computer system validation,” and agile modern development trends within GXP and medical devices.

We are planning future events now and will keep you posted. Please feel free to let us know what topics you’d like to see covered as it relates to devising and maintaining an effective eQMS.