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# MODULE 5: EXECUTING IQ, OQ, PQ WITHOUT CREATING FINDINGS

What is this course about?

Who is this mini-course for?

Teaching goals

# SLIDE 1 — THE PROTOCOL THAT COULDN'T BE READ

Slide Content

Monologue Script

Trainer Notes

# SLIDE 2 — WHAT EACH QUALIFICATION ACTUALLY PROVES

Regulatory alignment

Common misconception

# SLIDE 3 — CASE STUDY: THE STEP THAT FAILED AT 6PM

# SLIDE 4 — DOING IT CORRECTLY

DO ✓

AVOID ✗

Risk indicators

Expert commentary

# 10-POINT AUDIT CHECKLIST — MODULE 5

10-POINT AUDIT CHECKLIST — MODULE 5

Part A — Quiz

Q1. A test step fails. The project manager believes it was an environment issue. What is the correct action?

Q2. Which entry in an "actual result" field is acceptable?

Q3. During execution the tester discovers the expected result in the protocol was written incorrectly — the system behaviour is correct. What should happen?

Q4. What does Performance Qualification verify that Operational Qualification does not?

Q5. An executed protocol contains 380 steps and zero recorded deviations. How should a reviewer treat it?

Part B — Reflection

Part C — Top five takeaways

Welcome to "Validation Execution Discipline: Managing Test Scripts and Documentation. " In the highly regulated sectors of pharmaceuticals, medical devices, and life sciences, executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) flawlessly is absolutely critical.

Welcome to "Validation Execution Discipline: Managing Test Scripts and Documentation." In the highly regulated sectors of pharmaceuticals, medical devices, and life sciences, executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) flawlessly is absolutely critical. A single poorly documented test step, an unreadable protocol, or a mishandled deviation can lead to severe compliance findings, costly project delays, and compromised product quality. This comprehensive mini-course is meticulously designed to equip validation professionals, quality assurance specialists, and project managers with the exact discipline required to execute and manage test scripts without triggering regulatory audit findings.

Through engaging real-world case studies—such as the infamous "step that failed at 6 PM"—and practical, hands-on modules, you will learn the critical differences between what each qualification phase actually proves versus common industry misconceptions. We will dive deep into regulatory alignment, proper Good Documentation Practices (GDP), clear guidelines on what to DO and what to AVOID, and how to handle unexpected deviations like environment issues or incorrectly written expected results.

By the end of this course, you will master a robust 10-point audit checklist to ensure your executed protocols are completely bulletproof. Whether you are reviewing a massive 380-step protocol with suspiciously zero deviations or documenting actual results in real-time on the shop floor, this course provides the expert commentary and risk indicators you need. Elevate your compliance standards and maintain impeccable validation execution discipline today.

CSV Module 5: Validation Execution Discipline: Managing Test Scripts and Documentation

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            <p>The integrity of computer system validation relies heavily on the rigorous execution and meticulous documentation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. For validation specialists, quality assurance reviewers, engineering staff, and subject matter experts, the execution phase is not merely a bureaucratic exercise but a fundamental demonstration of system compliance and reliability. Poorly documented test scripts, unreadable protocols, and improperly handled test failures routinely lead to significant regulatory findings and compromised system integrity. This curriculum addresses the critical discipline required to manage test scripts and documentation effectively, ensuring that every signature represents verifiable, witnessed, and strictly compliant testing activities.</p>

<p>Throughout this comprehensive training, participants will examine the precise methodologies required to execute qualification protocols without generating avoidable compliance findings. By analyzing real-world scenarios—such as protocols rendered illegible by poor documentation practices and test steps that fail under pressure—professionals will learn to navigate complex execution challenges with regulatory precision. The course clearly delineates what each qualification phase actually proves, highlights common industry misconceptions, and provides actionable frameworks for distinguishing between correct and incorrect documentation practices. Supported by detailed case studies, expert commentary, and a rigorous 10-point audit checklist, this material equips IT testers, manufacturing personnel, and quality approvers with the definitive standards necessary to maintain impeccable validation records and ensure total audit readiness.</p>
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