Publications | Empowerment Quality Engineering

AI / ML 1 article

Introduction to Machine Learning

Graphic Guide Accessible overview of ML concepts for the GxP professional

IT Vendor Auditing & Software Product Quality 6 articles

Series Summary Overview of the full 4-part vendor audit series

Measuring Vendor Software Quality

Part 1 of 4 Establishing a baseline for supplier quality measurement

Test Strategies & Techniques

Part 2 of 4 Risk-based test strategy design for regulated environments

Quality Analytics

Part 3 of 4 Using metrics to demonstrate and drive software quality

Test Automation: What and How

Part 4 of 4 Practical automation strategy and tool selection in GxP contexts

ISPE External Published by ISPE — Appendix 6: Requirements Planning

Agile in Regulated Environments 3 articles

What is Agile?

Primer An accessible introduction to Agile methodologies for quality professionals

Agile Glossary

Reference Key Agile terminology decoded for the GxP and regulatory context

Agile: Challenges for the Auditor

Audit Focus Navigating compliance challenges when auditing Agile development teams

GDPR & Data Privacy 2 articles

Policy Analysis Practical impact of Brexit on cross-border data transfers and GDPR compliance

ECJ vs EU–US Privacy Shield

Legal Analysis Implications of the Schrems II ruling for transatlantic data flows

Cybersecurity & Data Integrity 2 articles

Auditor Tips Security-by-design principles applied to validated computerised systems

Regulatory FDA guidance on cybersecurity requirements across the device lifecycle

Conference Presentations 4 presentations

Presentation Applying risk-based thinking throughout the computerised system lifecycle

Presentation How to embed meaningful measurement into a Computer Software Assurance programme

Presentation Techniques for assessing real software quality beyond QMS documentation

Presentation A critical examination of Agile quality outcomes in regulated environments

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