Qualityze Validation Services: Ensuring Quality and Reliability

Efficient and Thorough EQMS Validation: Qualityze Methodology

Validating the EQMS software is important to ensure the effectiveness and reliability, as it verifies compliance with predefined quality standards and regulatory requirements. Qualityze follows a systematic approach to EQMS Validation Services, ensuring both compliance and effectiveness of the software.

Qualityze EQMS system being a highly configurable system, can be used implemented for production use in two ways by our customers:

1. COTS (Commercial Off-The-Shelf)

   Qualityze EQMS system can be implemented as-is, without any configuration and is considered “out-of-the-box” solution which includes standardized functionalities and features that can be quickly implemented to meet specific business needs.

2. CCS (Custom Configured System)

   Qualityze EQMS system can be implemented and further configured on top of “out-of-the-box” solution to meet the customer specific requirements.

To meet the validation requirement Qualityze follows the steps below to ensure end-to-end validation of both implementation approaches:

• Validation Planning: Qualityze starts by developing a validation plan that outlines the scope, objectives, and activities to be performed during the validation. It serves as a roadmap for the validation project and ensures that the validation effort is properly planned, executed, and controlled, helping to achieve compliance with regulatory requirement and quality standards. It also establishes clear roles and responsibilities, identifies validation resources and timelines, and defines acceptance criteria and success criteria for the validation activities. Ultimately, the Validation Plan acts as a crucial reference document that guides the validation team throughout the entire validation process.
• Functional Requirements Specification (FRS): Functional Requirements Specification (FRS) document define the out-of-the-box standard functionalities and features of a Qualityze software system that can be quickly implemented to meet specific business needs. It also serves as a reference for validating the out of the box software product that meets the specified functional requirements.
• Installation Qualification (IQ): This step involves verifying that the EQMS software is properly installed and configured according to the Installation Guide. Qualityze ensures that the installation is carried out correctly and documented appropriately.
• Operational Qualification (OQ): Qualityze conducts thorough testing and verification activities to confirm that the EQMS software operates as intended. This includes testing individual features, functionalities, and modules to ensure their compliance to predefined requirements of FRS.
• Functional Requirement Traceability Matrix (F-RTM): The F-RTM document maps each requirement of FRS to the corresponding testing activities in OQ. It ensures that all requirements are properly linked to the associated test cases, enabling comprehensive test coverage. Using RTM validation team can effectively demonstrate the traceability and validation of each requirement, providing a clear audit trail for regulatory compliance and quality assurance purposes.
• Requirements Specification Document (RSD): Requirements Specification Document (RSD) define the customer specific requirements which is to be performed on top of OOB functionalities and features of a Qualityze software system which needs to be configured to meet specific business needs. It also serves as a reference for validating the customer specific requirements that meets the specified business requirements. This document is generated during the design workshop that will be conducted during the implementation.
• Performance Qualification (PQ): Qualityze will assist in the creation of PQ scripts to validate the customer-specific requirements and customizations implemented on top of the out-of-the-box (OOB) functionalities and features. These scripts will ensure that the configured EQMS software operates as configured. The testing process will encompass individual requirements, workflow configurations, field-level changes, and business logic modifications within each module to verify their compliance with the requirements of the Regulatory Submission Document (RSD).
• Customer Requirement Traceability Matrix (C-RTM): The C-RTM document maps each requirement of RSD to the corresponding testing activities in PQ. It ensures that all requirements are properly linked to the associated test cases, enabling comprehensive test coverage. Using RTM validation team can effectively demonstrate the traceability and validation of each requirement, providing a clear audit trail for regulatory compliance and quality assurance purposes.
• Validation Summary Report: Upon completion of the aforementioned activities, a Validation Summary Report is generated for each module. This report provides a comprehensive overview and documentation of all the validation activities conducted throughout the validation process. It serves as a summary and consolidation of the validation results, findings, and conclusions specific to Qualityze EQMS software.

By following this approach, Qualityze ensures that the EQMS software meets the necessary quality standards and regulatory requirements, providing organizations with a reliable and compliant solution for their quality management needs.