The Validation Process
Streamlined Validation Process
For Smooth Implementation
Ensuring A Thorough And Efficient Software Validation
Ensure the successful implementation of our software solutions in pharmaceutical organizations with our comprehensive validation process. Our streamlined validation approach combines industry best practices with efficiency, allowing you to meet regulatory requirements while minimizing disruption to your operations. With our proven validation process, you can have confidence in the reliability and compliance of our software.
Summarizes the system function capabilities based on User Requirements Specification (URS). Describes processing for each User Role and Menu Item.
Scripts
Step-by-step tests (Test Scenarios) for system functions. Includes "click by click" instructions and expected results—Validates software functionality and compliance.
Qualification
Scripts
Covers technical aspects, aligning setup with specifications and best practices to ensure correct software installation and configuration.
Matrix
Ensures comprehensive coverage and traceability by establishing a clear link between FRS functions and validation scripts.
Results
Document
This document lists test results for all OQ scripts. A list of test steps is printed for each OQ script. For each test step, the expected and actual results are shown. The document confirms that all OQ scripts were passed and formally signed off by the tester and reviewer.