Bridging Quality and IT: Building a Unified Validation Framework Across Departments
A validation framework is the foundation of trust between Quality and IT. It defines how teams plan, test, and maintain systems that su...
An Introduction to Computerized System Validation
Computerized system validation is the backbone of safe, compliant digital operations in regulated industries.
In this blo...
Automated Validation Testing: What It Is and How You Can Benefit
Automated validation testing is one of the most discussed topics in life sciences technology right now. Many teams see automation as th...
Cloud Validation in SaaS and Hybrid Environments
Cloud validation means making sure cloud systems used in regulated settings do what they should, and stay compliant over time. It’s abo...
Preparing for an FDA or MHRA Inspection: Validation Documentation That Stands Up
Why Validation Documentation Is Scrutinized During InspectionsCore Validation Documents Auditors ExpectURS, FS, DS, IQ/OQ/PQ, Summary R...
AI in the Age of Regulated Work with ALCOA+ Principles
TL;DR
What changes with AI: You now create records at three points: training data, prompts, and outputs. Treat each as controlled.
...
CSV vs CSA in 2025: What Changes and What Doesn’t
Computer software assurance is the FDA’s risk-based way to build confidence in software that supports production and quality activities...
Metrics that Matter in Validation Lifecycle Management
Validation lifecycle management is not a one-off task. It is the system that plans, builds, tests, releases, and maintains GxP changes ...
Data Migration Validation for Regulated Systems
CSV data migration is the controlled process of moving regulated records between systems and proving, with evidence, that the records k...
FDA’s Guidance on Data Integrity
FDA’s guidance on data integrity lays out how drug makers can ensure their records are complete, accurate, and reliable.
In this bl...