The proof is in our customers’ results. Find out how our continuous validation and GxP compliance solutions have transformed validation at these life sciences companies.
Meeting Validation and Compliance Challenges With Innovation Solutions
Continuous validation means our clients never have to worry about upgrades or new releases.
xLM Validates Continuously Qualified AWS Service for meshMD Against a Tight Deadline
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.Transitioning to the AWS Public Cloud
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.Delivering Continuous GxP Compliant Qualification for AWS
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.
- meshMD needed to transition data from multiple brick-and-mortar providers to AWS.
- They had only four weeks to figure out how to qualify their AWS infrastructure.
- Because they serve large pharmaceutical companies, their AWS services must meet highly stringent GxP, HIPAA, and privacy requirements.
- xLM collaborated with meshMD to define the intended use of their AWS services.
- Our team created a qualification plan and delivered a complete GxP-compliant continuous qualification package.
- xLM continues to manage AWS qualifications for meshMD.
“xLM’s continuous validation solution did everything we needed. Within a very short period of time our AWS was qualified and validated. The best part was that we could completely trust the experts at xLM every step of the way. They are pros who understand the regulatory landscape better than any team we’ve come across in our 11 years in business.”
We’re Built on Your Trust
xLM’s Quality Management System (QMS) is based on industry standards as well as applicable GxPs and enables us to deliver managed services that not only meet but exceed the expectations of regulatory standards in the United States, Europe, and Japan. The quality frameworks that form the foundation of xLM have also shaped many of our clients’ quality organizations worldwide.
- A specialty pharmaceutical company needed to validate its TraceLink track-and-trace implementation.
- The company also needed its TraceLink apps validated on an ongoing basis.
- The solution had to be cost effective.
- xLM developed a continuous validation framework for all TraceLink apps.
- Our team ensured the cost was less than 50% of conventional validation.
- xLM also created a robust framework to manage ongoing validation of TraceLink's new releases.
xLM Cuts Validation Cost in Half for Veloxis Pharmaceuticals
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.
xLM Builds Continuous Validation Package for AODocs
AODocs, the leading provider of cloud content services, has built several successful management apps that run on Google Cloud Platform. With the launch of AODocs for Life Sciences, they needed a technology-driven validation partner to meet their GxP customers’ needs.
Eliminating the Validation Burden for AODocs’ Customers
To alleviate the validation burden entirely for AODocs’ life sciences customers, xLM built a continuous validation package that independently validates every new AODocs release. All of AODocs’ life sciences customers automatically receive access to the xLM Platform Qualification package, which manages initial as well as ongoing validation.
Helping AODocs Deliver Exceptional Customer Service
Because AODocs’ Customers don’t have to worry about validation, they can focus their efforts and resources on higher-value projects. xLM’s ongoing partnership with AODocs also saves the company 50% on traditional validation costs while compressing validation timelines by 75%.
- AODocs wanted to launch cloud content management apps into the life sciences space.
- To do so, they needed a validation partner that could meet the needs of their GxP customers.
- Because AODocs continuously releases new apps, the validation solution must be ongoing.
- xLM built a continuous validation package to independently validate every new AODocs release.
- All AODocs life sciences customers get automatic access to the xLM qualification package.
- xLM reduced validation costs by 50% and compressed validation timelines by 75% for AODocs.
- Omniscient was developing its first software medical device to be submitted to the U.S. Food and Drug Administration. They needed a partner who understood the qualification of the AWS infrastructure and validation of an SaMD (Software As a Medical Device).
- They needed a partner who was well versed since their first 510(k) was at stake.
- xLM qualified their AWS Infrastructure using their novel Continuous Qualification for Cloud Services.
- xLM validated their Quicktome SaMD on time.
- Omniscient got their first 510(k) in record time for a complex application.
xLM Qualifies and Validates AWS and Quicktome for Omniscient
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.
“xLM was able to demonstrate a deep understanding of the space our software occupies (cloud medical device solution). This made us confident that xLM was the right partner.”