Qualityze Validation Services: Ensuring Quality and Reliability

Managing the validation process and achieving compliance can be challenging. Qualityze offers a proven comprehensive validation methodology to help you overcome these challenges. Our experienced team can assist you with documenting end-to-end validation process, including authoring and reviewing the Requirement Specification Document (RSD), RSD to Requirement Traceability Matrix (RTM), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The objective of our validation service is to ensure that our customers are audit-ready, confident and compliant.

The Qualityze Validation Package offers a complete set of pre-configured validation ready templates:

  • Cloud System Validation Plan (VP)
  • Functional Requirements Specification (FRS)
  • Validation Test Scripts (IQ, OQ)
  • FRS to Test Traceability Matrix (F-RTM)
  • Software Validation Summary Report Template (VSR)

Qualityze offers validation services to help validate each release of the Qualityze EQMS Suite. Our validation team can work within your specified timeline and provide compliance-ready documentation before Qualityze EQMS Suite is used in production. This allows your team to focus on quality processes and delivering high-quality products to your customers.

By utilizing Qualityze’s validation services and leveraging our comprehensive set of pre-configured templates, you can optimize the validation process and ensure compliance to regulatory requirements.

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.

Keys Benefits of Choosing Qualityze Validation Services

Choosing Qualityze EQMS Validation Services offer following benefits:

Compliance Assurance:


Compliance Assurance: Qualityze ensures that your EQMS software meets regulatory requirements and industry standards. By validating the system, they help you demonstrate compliance and mitigate risks associated with non-compliance.

Expertise and Experience:


Qualityze brings extensive expertise and experience in EQMS validation. Their team understands the intricacies of validation processes and stays updated with evolving regulations, ensuring thorough and reliable validation of your EQMS software.

Cost and Time Efficiency:


By leveraging their validation expertise, Qualityze helps streamline the validation process, saving you time and reducing costs. Their efficient approach minimizes disruptions to your operations and accelerates the implementation of your EQMS.

Tailored Validation Approach:


Qualityze understands that every organization has unique requirements. They work closely with you to develop a validation plan that aligns with your specific needs, ensuring that the validation process is customized and focused on the areas critical to your business.

Risk Mitigation:


Qualityze validation services mitigate risks associated with software malfunctions, data integrity issues, and non-compliance. Through comprehensive testing and verification, they identify and address potential risks, ensuring the reliability and effectiveness of your EQMS software.

Documentation and Reporting:


Qualityze provides detailed documentation throughout the validation process. They generate comprehensive reports that demonstrate compliance, capture test results, and document any deviations or corrective actions taken. These records serve as valuable evidence during audits and regulatory inspections.

Ongoing Support:


Qualityze offers ongoing support even after the validation process is completed. They provide assistance in maintaining the validated state of your EQMS software, keeping it up to date with evolving regulations and best practices.

Enhanced Confidence and Trust:


By choosing Qualityze Validation Services, you gain confidence in the compliance and reliability of your EQMS software. This trust allows you to focus on your core business activities, knowing that your quality management system is robust and compliant.

Overall, Qualityze Validation Services provide peace of mind, cost savings, compliance assurance, and a streamlined validation process, allowing you to leverage the full benefits of your EQMS software while meeting regulatory requirements and industry standards.