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Computerized Systems Validation

All software used for regulatory activities within healthcare companies must be validated to comply with applicable regulations. Computerized system validation (CSV) involves documenting all processes, from specifying the system requirements to training the users. The current approach, which relies on paper and manual systems, is time consuming and inefficient as documents are needlessly recreated and tedious manual tasks are performed on a daily basis.

 


 QAvalid CSV™


 QAvalid CSV™ is a Web based system designed to manage efficiently the complete validation lifecycle for computerized systems. Life Science companies can replace tedious paper or manual systems with a fully electronic, automated validation environment that supports the risk based approach.  


Users work in a controlled and compliant manner in Microsoft® Office and the system drastically improves validation efficiency by automating recurring tasks, supporting information reuse, improving visibility or generating up-to-date traceability matrices and displaying the impact of any change.

 

 


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Save up to 60% of Your Validation Costs 


Putting the spotlight on the true validation problems and using innovative technology to fix them has made QAvalid CSV™ the most efficient enterprise validation management solution, reducing up to 60% of validation costs.

The application includes document and project templates based on GAMP 5 industry guidance, enables electronic testing and test incident reporting, integrating FMEA risk assessments and requirements management capabilities and meets FDA’s Part 11 requirements for electronic signatures and electronic records. The centralized electronic system ensures that people always have the latest version of a document and provides oversight of all validation processes enabling managers to make proactive decisions and save precious time.

 


Ensure Your Standardized Validation Approach

Managers can standardize validation activities across multiple sites by defining standard document templates and workflows and ensuring that mandatory information is captured in the desired format. In addition, the solution provides real-time visibility of the project status and the progress inside each document through standard reports and allows users to build customized reports using tools such as Crystal Reports.



Continue to Use Word but Increase Compliance


Unlike other solutions, QAvalid CSV™ does not require users to re-enter information and allows users to work in a familiar and yet controlled and compliant manner. The QAvalid Add-In for Microsoft® Office enables them to perform controlled writing, reviewing, approving or test execution even in offline mode while all related project documents are always available for referencing.

Integrated within QAvalid CSV™ the change control and system inventory modules ensure that all changes are implemented by using a pre-defined process and that managers can track the validation status of any system and promptly retrieve the related documents to justify the current status whenever audited or inspected.

 


Automatically Generate Your Traceability Matrix

The unique Linksense™ technology supports the generation of up-to-date traceability matrices on demand, helping users check that requirements have been verified and tested and allowing them to justify the extent of testing based on risk. The time spent to update documents is drastically reduced as the system displays the impact of any change. When changing one document, users can promptly identify related content that would need to be updated.

QAvalid CSV™ is part of the QAvalid suite designed to manage and automate quality and compliance processes. QAvalid integrates and connects quality processes, providing a single, Web based platform which allows users to create, control and track information and still work in a simple and flexible manner.

 

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