From Out-of-Spec Results to Audit-Ready: Controlling Titration in GxP Labs

61 min

// Pharmaceutical

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.

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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