Validation Packages Subscription
This comprehensive validation package provides a structured approach to verifying and documenting that your CIQA eQMS system meets all regulatory requirements and functions as intended.
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This comprehensive validation package provides a structured approach to verifying and documenting that your CIQA eQMS system meets all regulatory requirements and functions as intended.
Last updated
Was this helpful?
Our integrated system tool offers users centralized access to the latest CSV version of the CIQA eQMS. This feature is exclusively available with the . To gain access, please contact your Team Owner or Admin for subscription details and necessary permissions.
Notes: The user must have an active subscription in order to access. Remember that in order to access the section, the user must be the Team Owner or an Admin to access it in the 's section. They can assign the subscription to the team members they desire, the subscription is individual and cannot be used or swapped between teams. If the user cancels their membership, the user will not have access to the files even if the subscription was paid for the whole year.
• Validation Master Plan (VMP): A roadmap outlining the overall validation strategy, objectives, scope, methodology, and responsibilities.
• Validation Plan: A detailed plan providing a step-by-step approach to validation, including specific objectives, scope, and testing procedures.
• Design Documents: In-depth technical documents outlining the system architecture and its components.
• User Requirements Specification (URS): A comprehensive document specifying all user needs and functionalities the system must fulfill.
• Traceability Matrix: A matrix that maps user requirements to corresponding system functionalities, ensuring all needs are met. Included in the IQ, OQ, and PQ.
• Installation Qualification (IQ):
Protocol: A complete document ensuring that CIQA QMS v1 is installed correctly and meets all specification requirements.
Test Case Execution: Detailed test cases verifying that each system component is installed as intended.
Final Report: A comprehensive report summarizing the installation verification process, results, and any deviations observed.
• Operational Qualification (OQ):
Protocol: A complete document ensuring that CIQA QMS v1 functions as intended under normal operating conditions.
Test Case Execution: Detailed test cases confirming that each functionality operates as intended.
Final Report: A comprehensive report summarizing the operational verification process, results, and any deviations observed.
• Performance Qualification (PQ)
Protocol: A complete document ensuring that CIQA QMS v1 performs consistently and reliably within established tolerances.
Test Case Execution: Detailed test cases verifying that the entire system meets expected performance conditions.
Final Report: A comprehensive report summarizing the performance verification process, results, and any deviations observed.
• Automatic Updates: If any module is updated, the system will automatically upload and modify the document to its current version, ensuring you always have the most up-to-date information.
• Current Version Display: Only the final or current version of the document will be displayed, eliminating any confusion with outdated files.
• PDF Viewing: All files can only be viewed as PDFs, providing a consistent and secure viewing experience.
1. Click the Shop tab: Located on the top menu.
2. Select the Validation Packages Subscription: Option from the dropdown menu that appears.
To view file details, simply click on the file box. Information for the selected file, along with options to handle the file, will appear.
On the left side of the page, there is a filtering system where the user can filter and search for specific documents belonging to a specific module.
When you click on a module name in the filter column, the documents related to that module will be displayed.
To learn how to use the search filters, please click .
