Validated Cloud is a reality!
Are you are using any cloud app with GxP workloads?
Select ValiMation as your managed service provider.
Use your cloud service as a "validated" service continuously.
CLOUD VALIDATION SERVICES
Cloud Validation Services
Perform due diligence to ensure your cloud service complies with the industry standards and applicable GxP regulations.
Validate the cloud app for its intended use
Continuously validate your cloud app so that you can keep using it.
“ValiMation has been instrumental in Romark’s successful and on-time implementation of Tracelink’s Life Science Cloud for our Track and Trace app. ValiMation has been extremely proactive in understanding Romark’s requirements as it relates to change controls and validation and have demonstrated in depth expertise in the overall execution. We plan to leverage our partnership to ensure that we maintain our compliant state using their continuous validation platform.”
CLOUD IAAS/PAAS/SAAS VALIDATION
Cloud IaaS/PaaS/SaaS Validation
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 and integrity are 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.
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 “continues” to meet thus mitigating the risk of unknown changes.”
XLM CONTINUOUS VALIDATION MANAGED SERVICE
xLM Continuous Validation Managed Service
Managed Service
xLM’s Continuous Validation is a managed service. It is designed to provide end to end validation service for your cloud app like Veeva, TraceLink, ServiceNow, ServiceMax, Jira and many more…
TECHNOLOGY PLATFORM
Our managed service is based on our sophisticated technology platform specifically designed for cloud app validation. It is designed to handle all three layers (IaaS, PaaS, SaaS).
QMS
Our managed service is built on a robust QMS that is compliant with 21 CFR Part 11, Annex 11, ISO 9001:2015, ASTM E2500.
“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’.”
COMPUTER SYSTEMS VALIDATION SERVICES
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.”
FEATURED BLOG POSTS
Featured
FDA released its final guidance on “Data Integrity and Compliance with Drug cGMP” in December 2018. The main purpose of this guidance was to clarify the role of data integrity in current good manufacturing practice (cGMP). This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with cGMP requirements.