We have had the pleasure of working with xLM's continuous validation which has significantly enhanced our company's operational efficiency and validation compliance. The platform's automated validation processes and real-time compliance monitoring has been instrumental in streamlining our workflows and ensuring stringent adherence to industry standards. xLM's profound GxP knowledge and IT expertise have been pivotal in bolstering our technology's data integrity and compliance, providing us with the confidence that our systems are both robust and reliable. The team's professionalism and ease of collaboration have made our journey towards GxP compliance not only successful but also highly rewarding. To other companies seeking to navigate the complex landscape of continuous validation and GxP compliance, partnering with xLM offers not just a solution but a transformative experience, ensuring that compliance is seamlessly integrated into the fabric of your operations.

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 solutions with real-time access to its 'Validation Health'."

I have worked with Nagesh and his team for many years, spanning several different large pharma companies in both the manufacturing and research quality spaces. Their system GxP capabilities and expertise in both system development and regulatory compliance is superior. They are the first place I go when looking for GxP systems support as I know we will receive the right subject matter expertise and high quality deliverables.

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. We needed a partner who understood the qualification requirements of an AWS infrastructure and validation of a SaMD (Software As a Medical Device). xLM helped by augmenting our testing resources to qualify the cloud and to help with validation of our SaMD, delivering the project on-time and on-budget, which allowed us to seek clearance from the FDA and start commercializing the product.

xLM teams' depth of expertise in IT GxP Compliance and their unique toolsets that automates and accelerates manually labor intensive GxP Validation procedures have proved to be extremely valuable for SCA's GxP Compliance needs. Glad to have a partner in xLM for our GxP Systems support and validation requirements.

Mansi Joshi, Project Manager - Solution Delivery, worked in the validation of IQVIA SmartSolve Document, Training, Change, Deviation, and CAPA modules. The time frame of this work was from June 2022 through May 2023. Mansi's work was extraordinary and greatly exceeds expectations. During the validation runs, she worked tireless hours as OrganaBio is located in Miami Florida and Mansi is in India. There was no delay from xLM at any time. All deliverables were completed in time, as committed to do so. The technology and methodology to run validation is efficient and fast. I personally thanks Mansi for her dedication and commitment to this project. I strongly recommend xLM for all type of validation projects.

I appreciate the thoughtfulness and understanding your team put in towards mapping out our toolbox processes, and it was interesting to see the process map you had created. Your team has positively impacted our toolbox platform by providing validation to our GxP critical production related tools and we appreciate everything you and the team have contributed!

What specific features of xLM's solutions have been most beneficial to your team? In working with xLM, all solutions are robust, simple, efficient and compliant. The xLM team is collaborative and customer centric. xLM stands behind all deliverables and will go above and beyond to ensure customer satisfaction. - How would you describe your overall experience working with xLM in ensuring GxP Compliance? My overall experience working with xLM dates to 1995 when they were known as ValiMation. In the 30 years I have known and worked with Nagesh and his team, they have been professional, ethical, on-time and on-budget and customer centric. All challenges were met with simple, efficient and logical solutions. - What would you say to other companies considering using xLM for continuous validation and GxP compliance solutions? For companies searching for a subject matter expert in GxP compliant, systems solutions, please conduct your due diligence and consider multiple vendors. In consideration of xLM (compared to like providers), you will find Nagesh and his team to meet or exceed all determinate factors.

ValiMation is a great choice for computer system validation. They are knowledgeable, responsive and provide value to our compliance program.

xLM has been instrumental in Romark’s successful and on-time implementation of Tracelink’s Life Science Cloud for our Track and Trace app. We plan to leverage our partnership with xLM to ensure that we maintain our compliant state using their continuous validation platform.

The views are expressly mine and do not represent the official position of Clene Nanomedicine, Inc. I was introduced to Nagesh Nama and his team of software/hardware validation experts at ValiMation in mid-2021 to support a manufacturing upgrade process at our pre-commercial facility. Nagesh and his team were quick to arrive on-site, holding various pre-project stakeholder meetings to determine the scope of the project. During the first of these meetings, it became clear that Nagesh was a one-of-a-kind resource. His knowledge of the regulatory requirements coupled with best manufacturing practices enabled us to successfully complete our validation project without the burden of being weighed down by unnecessary steps. Another distinguishing factor with Nagesh and ValiMation is that project support extends well beyond the scope of services. By developing a relationship with ValiMation, you create a conduit to the latest techniques and expertise within the validation space for many years beyond your initial project.

XLM has been an excellent resource for our project team by providing GxP compliance support on meticulous quality documentation, assistance with executing test plans and aiding in the closeout process. The organization is staffed with detailed oriented professionals that are well managed and versed to take on the any challenge. I am honored to partner with this organization to deliver projects to my stakeholders and I can trust the XLM team will execute with confidence and integrity.

This partnership brings cost-efficient validation that also saves time. Our customers have access to all our apps that are delivered "validated" with real-time access to validation health.