From Out-of-Spec Results to Audit-Ready: Controlling Titration in GxP Labs
When titration results fall out of specification, resolving the chemistry is only part of the solution. In regulated pharmaceutical laboratories, it is equally critical to demonstrate control over the workflow that produced the result.
Unexpected OOS (out of spec) often stem from subtle but significant factors like electrode performance issues, matrix interferences, or poorly optimized Karl Fischer parameters. In this case study focused mini course, Eduardo Simões, Titration Product Specialist, walks through the most frequent pitfalls encountered in potentiometric and Karl Fischer analyses and demonstrates practical, standards aligned strategies to correct them at the bench.
Building on these corrective actions, Martin Kobler, Senior Product Specialist for Software, demonstrates how compliant digital controls ensure those improvements are consistently applied and defensibly documented. Through structured user roles, controlled method versioning, secure review workflows, and a comprehensive audit trail, participants will see how software transforms troubleshooting into a repeatable, inspection ready process.
Participants will gain a clear framework for preventing recurring deviations, strengthening data integrity, and maintaining inspection-ready titration workflows. Stick around for a live Q&A to explore how these strategies apply to your own titration challenges.
Please plan to attend if you want to:
- Identify KF and potentiometric failure modes and apply compendial‑aligned corrective actions
- Connect analytical troubleshooting steps to compliant software controls and audit trail documentation Implement best practices that improve method robustness and consistency in a GxP environment
Key Learning Points
- Identify the primary causes of out-of-specification titration results.
- Apply practical, standard-aligned corrective actions for potentiometric and KF analyses.
- Understand how digital controls strengthen data integrity through role management, version control, and secure review workflows Learn how software tools create defensible, audit‑ready documentation.
Presenter: Martin Kobler (Sr. Product Specialist, Software, Metrohm USA)
Martin Kobler is the Senior Product Specialist for Software at Metrohm USA where he supports the OMNIS platform and its integration across laboratory environments. Based in Riverview, Florida, he works within the Marketing – Product Management department and collaborates closely with product teams, technical specialists and customer-facing groups to guide software adoption and ensure users can fully leverage OMNIS capabilities.
With extensive experience supporting Metrohm’s digital solutions, Martin provides expert instruction on software functions, compliant workflows and method execution. His background includes deep familiarity with customer needs and hands-on guidance that helps laboratories transition smoothly to modernized, secure and audit-ready software ecosystems. He is frequently engaged in internal training, live demos and cross-functional initiatives to strengthen software proficiency across the organization.
He is based in Riverview and can be reached through his Metrohm USA contact channels.
Presenter: Eduardo Simões (Titration Product Specialist, Metrohm USA)
As the Titration Product Specialist at Metrohm USA in Riverview, Florida, Eduardo Simoes, MSc, leverages 22 years of practical experience in potentiometry and electroanalysis. His expertise spans instrument installations, technical support, and training, gained through extensive field work. He holds bachelor's and master's degrees in analytical chemistry from the University of Campinas, Brazil, providing a strong theoretical foundation for his hands-on approach.
