Programme Launch Offer: Save 20% - Book Now

EuroSTAR Conference

Europe's Largest Software Testing Conference.

Track Talk, T5

Testing What Matters Most in a GAMP5 World

Gitte Ottosen

11:30 - 12:15 CET, Tuesday 16th June

When you work within the Pharma domain, testing is not just about finding bugs, its about delivering proof to regulators, auditors (and yourself) that the GXP critical processes are not compromised when implementing changes to the system. There are a whole set of rules to follow in the context of QA and testing.

The rules are defined in the GAMP5 standard, a set of industry-standard guidelines, and an important aspect is that everything is classified according to the GXP criticality. Not only the system itself, but the individual business processes, definition of new features, and test related to this. There are demands to levels of documentation as well as being able to provide a high level of traceability between GXP critical business process and their related test.

When I joined a Dynamic 365 FO project, 132 business processes had already been documented and classified according to their GXP criticality. Test cases had been created for the processes, some of them automated, and some manual. This was a test suite that had to run EVERY TIME we had a release to validate that the business processes had not been compromised by the software delivery.

That all sounded great, but an analysis of the existing testware revealed that the coverage of these processes were really limited, thus not being sufficiently tested according to the identified criticality. The task was simple; ensure that processes match reality, and create test for them all – first manual, later automated.

This presentation will take you through the process we went through over a number of months, dumping the old testcases and starting from scratch, creating an effective and efficient test suite in collaboration with the business, a suite that covered the processes and added value – being sure that we were within the boundaries of GAMP5, and that we made the most effective regression suite possible.

What you will learn

  1. Build test suites in collaboration with process owners to ensure tests reflect how the system is truly used, while staying compliant with GAMP5
  2. Focus on traceable, risk-based test coverage, rather than maintaining large suites of outdated or low-value test cases
  3. Design regression suites that stay maintainable and valuable release after release, instead of becoming a compliance burden

Session Details

  • Intermediate
  • 45 mins
  • Includes 15mins Q&A
  • Navigating the evolving landscape of regulations
Buy Conference Ticket

Check out this video from Gitte Ottosen to hear more about their talk on Testing What Matters Most in a GAMP5 World.

We look forward to welcoming you to EuroSTAR 2026.

Session Speakers

Gitte Ottosen

Key2quality, Denmark

Gitte Ottosen is a test manager and quality coach with a strong focus on a value driven approach to software development. She has 30 years of experience in IT, primarily within test, test management and process improvement, in both traditional and agile contexts. She is focusing on supporting a quality mindset across teams and organizations in Denmark.

Gitte is a self-confessed test and agile evangelist who preaches the need for a strong quality and value driven focus,  a role requiring profound professional insight, passion, and persistence. Gitte is a dedicated trainer within the areas of agile and test.

Programme Launch Offer

Save 20% on individual tickets until February 28th!

The more you bring, the more you save.

Individual

From €1,840

3 Day Ticket*

BOOK TICKET

Groups

From €1,380

Based on 10 Tickets

Book Group

Stay in The Loop

Subscribe to our newsletter and never miss important announcements, updates and special offers from EuroSTAR.