services

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. 


 

Cloud infrastructure due Diligence

Audit the cloud IT infrastructure to ensure compliance with GxP and industry standards.  Ensure that the infrastructure is durable, secure, qualified and managed well.  And your data security is ensured.


Cloud Service Qualification

Qualify the entire cloud service from application provisioning, customer support, data backup and archiving, business continuity, etc..


Software App Validation

Develop a validation stack to capture its intended use and all other CSV mandates.   From URS/FRS/DS to IQ/OQ/PQ and more.   Execute the protocols and prepare the summary report.

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Continuous Validation

Establish a continuous validation platform that combines regression testing and new feature testing to continuously validate your cloud service.   You can keep using your cloud service while we are validating it for you.


Continuous validation is providing documented evidence to certify that a cloud app not only met the pre-established acceptance criteria, but “continuous” to meet thus mitigating the risk of unknown changes.
— Nagesh Nama, Chief Quality Officer (CQO)