ValiMation

Validated Cloud is a reality! READY - Are you ready to consume a Cloud Service? SET - Select ValiMation as your managed service provider. GO - Use your cloud service as a "validated" service. CLOUD VALIDATION SERVICES - Perform due diligence to ensure your cloud service complies with the industry standards and applicable GxP regulations. - Validate the cloud service for its intended use. - Continuously validate your cloud service so that you can keep using it. CLOUD IAAS/PAAS QUALIFICATION CLOUD APP VALIDATION - Step 1 - Audit your service provider's data center, cloud infrastructure, software app development, cloud service provisioning and ongoing support. - Step 2 - Audit the software app to ensure compliance with applicable regulations like 21 CFR Part 11, Annex 11. - Step 3 - Develop the validation stack based on your intended use. From URS to IQ/OQ/PQ and more. - Step 4 - Implement a continuous validation platform to validate your cloud app on an ongoing basis. xLM CONTINUOUS VALIDATION MANAGED SERVICE xLM platform that can "validation enable" any cloud app. You buy any cloud app and provide us your requirements on how you plan to use it - we will manage the validation for you. You use your cloud app and leave validation to us. COMPUTER SYSTEMS VALIDATION SERVICES Our Computer Systems Validation (CSV) methodology strives to achieve the 4Rs (Reliability, Robustness, Repeatability and Risk Based) in any application we validate. Our methodologies are consistent with GAMP5, ASTM-E2500, ISO, ICH and other industry standards. We call our methodology “Good Pragmatic Engineering Practices (GPEP)". We leverage Risk Management Techniques in all our engagements.