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Industry-standard validation practices performed by our certified representatives. Depending on the service chosen, this can include on-site or remote testing and validation of system requirements to support your compliance needs, including: Documentation that a computer system meets a set of defined sys...
“Kneat Gx” digitizes the entirecomputer system validationlife-cycle, delivering compelling productivity, cycle-time and compliance improvements. Kneat Gx allows you to manage all your computer system’s life cycle starting with requirements and critical process parameters through to Validation Final ...
Although the presented QMS and process for the computer system validation are related to a specific pharmaceuti cal company case and its legal requirements, the experience from this highly regulated industry can be appropriately used in other less regulated indu-stries. For verification ...
•ThepurposeofValidation(VAL)istodemonstratethataproductorproductcomponentfulfillsitsIntendedUsewhenplacedinitsIntendedEnvironment.VERIFICATION •Verification •ThepurposeofVerification(VER)istoensurethatselectedworkproductsmeettheirSpecifiedRequirements.Qualification:processofdemonstratingwhetheranentityiscapableof...
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Training Needs:If a company's employees need training on computer system validation, a CSV consultant can provide or help develop a comprehensive training program—and ensure the training meets both regulatory requirements and the company's specific needs. ...
"As your consultant I will provide personalized service for each member of your team so they learn how to work together and with computer systems to maximize productivity. I will promote your education and experience so that your company is compliant with regulatory requirements and is self-suffici...
(e.g., user requirements, assessments, protocols, reports, change controls). • The development of the validation strategy and validation plan for computer system validations. • Responsible for system/functional risk assessment, drafting, approval and execution of protocols and completion of ...
"As your consultant I will provide personalized service for each member of your team so they learn how to work together and with computer systems to maximize productivity. I will promote your education and experience so that your company is compliant with regulatory requirements and is self-suffici...