VALIMATION

Keeping you ahead of the cloud!

 
 
 
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Validated Cloud is a reality!

READY - Are you ready to consume a Cloud Service?

SET - Select ValiMation as your enabler.

GO - Use your cloud service as a "validated" service.

 
 
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services

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.

 
 
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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)
 
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services

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.


 

What is Continuous Validation?

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.  


By partnering with xLM, our customers are able to ‘validation enable’ their Cloudbyz CTMS implementations and be compliant while leveraging innovative cloud technology to achieve greater efficiency in clinical research. Our customers will be able to focus on using our cloud based solution with real-time access to its ‘Validation Health’.
— Dinesh Seshadri, CEO, Cloudbyz
 
 
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Yes we do this too!

Computer Systems Validation Services

 

Manufacturing Apps:  PLC, DCS, SCADA, MES....

Lab Apps: LIMS, SDMS....

Enterprise Apps: ERP, EDMS, CTMS, QMS....

IT Infrastructure: Networks, Datacenter, Private/Hybrid Cloud....

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.


ValiMation is a great choice for computer system validation. They are knowledgeable, responsive and provide value to our compliance program.
— Jim McElroy, Manager, Compliance Engineering, Novartis
 
 
 
 
 
 
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