Meeting Validation and Compliance Challenges With Innovative Solutions
Ensuring Seamless Compliance for meshMD’s AWS Migration
Challenges And Solutions
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.
xLM Enables Omniscient’s Breakthrough in Brain Mapping with FDA 510(k) domain
Challenges And Solutions
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 (FDA). 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 cIV - Continuous Intelligent Validation managed service. Leveraging its innovative cIV - Continuous Intelligent 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.
Challenges And Solutions
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 Veloxis called on xLM’s managed services. We developed a cIV - Continuous Intelligent 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.
Accelerate Your Digital Transformation
Find out how xLM’s automated validation testing platform can help you make validation your competitive advantage.
Get StartedLearn More About xLM’s Continuous Intelligent Validation (cIV) Platform
Challenges And Solutions
xLM Builds cIV - Continuous Intelligent 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 cIV - Continuous Intelligent 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%.
Challenges And Solutions
xLM Validates SAGE X3 ERP Systems for SCA Pharma Across Facilities
SCA Pharma, a sterile pharmaceutical manufacturing company, operates under stringent cGMP guidelines at its facilities in Windsor, CT, and Little Rock, AR.
To support its growth and meet regulatory expectations, SCA Pharma implemented the Sage X3 ERP system along with integrated Toolbox Apps to manage critical business operations. Ensuring that these systems were fully validated and continuously compliant was vital for operational success and audit readiness.
Validating a Complex, Multi-System ERP Environment
SCA Pharma required a partner with extensive life sciences expertise to oversee the validation of 79 applications and ensure alignment with regulatory and business requirements.
They chose to collaborate with xLM.
Delivering End-to-End GxP Validation and Ongoing Change Compliance
xLM worked closely with SCA Pharma’s business and IT teams to define the intended use of each module and application. Our team then provided a comprehensive GxP-compliant validation package, which included:
- Validation Master Plan
- User Requirements Specifications
- Functional & Configuration Specifications
- Automated and Traceable Test Protocols
- Comprehensive Risk Assessment and Traceability
Currently, xLM continues to manage the Continuous Validation of all Sage X3 ERP and Toolbox App changes, ensuring ongoing compliance, expedited change management, and audit-ready documentation.