This partnership combines Cloudbyz’s eClinical Trial Apps with xLM’s Continuous Validation service that enables delivery of “validated” apps.
xLM, LLC, the first managed service provider for delivering continuously validated cloud apps, today announced a partnership with Cloudbyz, a provider of eClinical apps built on Force.com.
Now Cloudbyz can deliver each of their cloud-based apps as a “validated” app that meets FDA’s 21 CFR Part 11 and related predicate regulations. xLM’s Continuous Validation Service handles all validation tasks from initial validation, upgrade/patch validation, new release validation and subsequent “continuous” validation. With xLM’s service, customers can view the “validation health” of their instance in real-time. xLM’s Service incorporates a robust Validation SDLC that includes Change Control, Traceability, Risk Management, Automated/Manual Test Frameworks, Real-time Summary Report Generation.
“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,” said Dinesh Sheshadri, CEO of Cloudbyz. “Our customers will be able to focus on using our cloud based solution with real-time access to its ‘Validation Health.”
“Continuous validation is providing documented evidence to certify that any Cloudbyz app not only met the pre-established acceptance criteria, but “continuous” to meet thus mitigating the risk of unknown changes.” said Nagesh Nama, Chief Quality Officer (CQO) of xLM, LLC.
About Cloudbyz Inc
Cloudbyz, Inc provides innovative cloud native applications and solutions to enterprises and clinical research organizations. Cloudbyz CTMS is an integrated clinical trial management application, which combines clinical operation capabilities, eTMF and real-time collaboration with sponsors, CROs and investigators. For more information call 312.763.8040, visit http://www.cloudbyz.com
About About xLM, LLC
xLM, LLC provides innovative continuous validation services by partnering with various cloud companies that cater to Life Science customers worldwide. xLM, LLC is a subsidiary of ValiMation, Inc. which was founded in 1996 and headquartered in Wayne, PA. xLM Managed Validation Service meets or exceeds GxP requirements established by the FDA, EMA. For more information call 610-644-4295, visit http://www.continuousvalidation.com or http://www.valimation.com