Validation Plan
The validation process begins with a detailed plan that outlines the scope, objectives, approach, and responsibilities for validating the computer system.
A Validation Plan serves as the foundational document that guides the entire Computer System Validation (CSV) process. A Validation Plan clearly defines the scope of the validation effort, outlining the boundaries of the system or process to be validated.
Validation Summary Report
Report summarize the results of the validation process, including any deviations, issues, and corrective actions taken.
The report provides a concise summary of all validation activities conducted throughout the validation process, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Functional Requirements Specification (FRS)
The FRS document delves deeper into the system's functionality, specifying how each function should operate and interact with other components.
FRS clearly defines the functions and capabilities that the software system must perform. It outlines what the system should do, including inputs, processes, and outputs.
Validation Protocols and Test Scripts
These documents outline the specific tests that will be conducted, including step-by-step procedures and expected results.
These documents outline the specific tests that will be conducted, including step-by-step procedures and expected results.
Traceability Matrix
This document links requirements to test cases, ensuring that each requirement is addressed during the validation process.
A Traceability Matrix is a structured document that plays a pivotal role in this process, linking requirements to test cases, thus providing a clear and traceable path to validating the functionality and performance of a system.
Configuration Validation:
Ensuring that the ERP system is correctly configured to align with the organization's specific needs. This includes validating configurations, Account mapping, customizations and inter-modules settings.
Configuration validation involves a comprehensive review system settings and configuration mappings to ensure that it aligns with the specific requirements of 21 CFR Part 11.