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CPIA Certification Program
Module 10: Testing & Validation in Pharmacy Systems
From Theoretical Safety to Proven Resilience: The Pharmacist’s Ultimate Gatekeeping Role.
From Final Check to Systemic Assurance
Throughout your pharmacy career, the act of “verification” has been your most profound responsibility. You have spent years perfecting the art and science of the final check—a meticulous, multi-faceted process that ensures the safety of a single medication for a single patient. You instinctively know how to scrutinize a prescription for errors, evaluate its appropriateness against a patient’s profile, and anticipate potential problems before they occur. This mindset is not just a skill; it is the core of your professional identity.
This module will show you how to scale that identity to the enterprise level. Testing and validation in pharmacy informatics is the act of final verification magnified a millionfold. You are no longer just checking one prescription; you are certifying the safety and resilience of the entire system that will process every prescription. Your innate ability to think adversarially—to ask “How could this go wrong?”—is your greatest asset.
We will move beyond the concepts of the SDLC and dive into the rigorous, disciplined practice of clinical software validation. You will learn to build comprehensive test plans, simulate catastrophic failures to ensure your systems can withstand them, and perform the root cause analysis that turns an error into a learning opportunity. This is the ultimate gatekeeping function in health IT, and it is a role that only a pharmacist, with your unique training and ethical commitment, can truly master.
Your Roadmap to System Validation Mastery
This module provides the practical tools and frameworks to ensure any pharmacy technology you manage is not just functional, but demonstrably safe and reliable.
10.1: Test Plan Development and Acceptance Criteria
A deep dive into creating the strategic blueprints for testing. Learn to define the scope, objectives, and resources for a testing effort and write crystal-clear acceptance criteria that form a contract for quality.
10.2: Unit, Integration, and Regression Testing
Explore the core layers of the testing pyramid from a pharmacist’s perspective. Understand how to design test cases that verify not only individual components but also the complex interactions between them, and master the art of regression testing to ensure a new feature doesn’t break an old one.
10.3: Downtime Simulation and Disaster Recovery
A critical masterclass in preparing for the inevitable. Learn how to plan and execute controlled downtime drills, test your backup and recovery procedures, and ensure your pharmacy can continue to provide safe patient care when the technology fails.
10.4: Bug Tracking and Root Cause Analysis
Transform from a bug finder to a problem solver. Learn to use tools like Jira for defect management and master the “Five Whys” and other root cause analysis techniques to move beyond fixing symptoms and start addressing the underlying systemic issues.
10.5: Validation Documentation Best Practices
Explore the art of creating an audit-proof paper trail. Understand the documentation requirements for regulatory bodies like The Joint Commission and learn to produce the validation summaries and sign-off reports that serve as the official record of your due diligence.
