xLM
Success Stories

meshMD delivers SaaS applications to over 20 of the largest pharmaceutical companies in Canada. 

When they had to move their GxP assets from multiple brick-and-mortar data centers to AWS because one of their providers was shutting down, they didn’t know how they were going to validate their AWS infrastructure.

The meshMD team had all the pieces of their transfer together but needed a partner that could qualify and validate their AWS public cloud in less than four weeks. They turned to xLM.

With the deadline looming, our team got to work. We collaborated with the technical staff at meshMD to define the intended use of their various AWS IaaS/PaaS services. Our team then created a qualification plan and delivered a complete continuous qualification package that met GxP compliance requirements, all in less than four weeks.

xLM continues to manage the qualification of all AWS services for the meshMD team, which relies on us to maintain compliance.

Veloxis Pharmaceuticals is committed to improving the lives of transplant patients. The company needed a cost-effective solution to validation-enable their TraceLink track-and-trace implementation.

Managing End-to-End TraceLink Validation

With limited resources to commit to validation, the pharmaceutical company called on xLM’s managed services.

We developed a continuous validation framework for all their TraceLink apps – SOM, SMM, SNX, and Product Track – and provided end-to-end managed validation services for their brand owner instance, which included several CMO and 3PL service connections.

Improving Business Outcomes

Veloxis Pharmaceuticals went live with their TraceLink implementation for less than 50% of the cost of traditional validation and with only 5% overall validation effort. Our team also developed a robust framework for managing all the company’s new releases, which can be up to six per year.

Omniscient is revolutionizing brain care by providing insight into neuropathology through advanced brain mapping and connectomic analyses. The company’s software platform enables better understanding of neurological disease, mental health, and more.

Omniscient was developing its first software medical device to be submitted to the U.S. Food and Drug Administration. The Quicktome device is a brain mapping platform that backs clinical decisions with detailed, patient-specific knowledge of the brain’s neural networks. For example, it can show a neurosurgeon where important brain networks are located before surgery. As a startup, Omniscient wanted to bolster its internal resources to quickly and accurately validate Quicktome functionality prior to product release.

AWS Infrastructure and Quicktome Validation

To meet its deadlines while adhering to compliance standards, Omniscient turned to xLM’s Continuous Validation managed service. Leveraging its innovative continuous validation technology, xLM ensured Omniscient remained on schedule by automating  qualification of its AWS infrastructure and the validation of Quicktome.

Delivered Validation that catapulted Omniscient into 510(k) domain

By qualifying and validating its AWS cloud and software, Omniscient launched Quicktome on time while maintaining FDA compliance.