Vaibhav Chimalgi Email & Phone Number

Are you looking to incorporate AI / ML into your validated processes?Are you looking to reduce GxP validation costs? Would you like to reduce risk, compress timelines while increasing compliance? Are you looking into moving away from CSV into CSA? Are you looking at creating robust digital data integrity program?We provide managed services that deliver AI apps that are Continuously Validated. We deliver a suite of Data Integrity services. WHO IS THIS FOR?Our clients range from multi-national pharmaceutical companies to nimble bio-tech and medical device companies.HOW DO WE HELP?We can help you increase efficiencies by incorporating AI and ML technologies into your validated processes.We can help you reduce GxP validation costs by more than 75% and compress timelines by more than 50%. We can help you transition from CSV to CSA.WHAT DO WE DO?We help our customers leverage their existing data by deploying AI/ML apps to reduce cost and increase compliance.We invented "continuous validation" which increases compliance, reduces risk and helps you get onboarded onto any cloud or on-prem platform. We cover IaaS, PaaS, and SaaS (the entire infrastructure and software stacks).Our managed services exceed the current expectations of the FDA's CSA. WHAT PLATFORMS AND APPS WE HAVE WORKED WITH?Sample Platforms and Apps:✔Public Cloud (IaaS/PaaS): AWS, Microsoft Azure, GCP✔Veeva Apps (QualityDocs, QMS, eTMF, CDMS, Safety, CP&C, RIM)✔Serialization (TraceLink, Axway)✔QMS (Veeva, AODocs, Intellect, IQVIA)✔ITSM (ServiceNow, Jira)✔LIMS (LabVantage, LabWare)✔ERP (SAP, Oracle)OUTCOMES YOU CAN EXPECT:✔Leverage your data to automate decision making using AI/ML. ✔Bring latest AI technologies into your validated processes.✔Establish a managed Data Integrity platform that is continuously validated.✔Your validation workload will be reduced by more than 90%. ✔Your validation spend will be reduced by more than 75%.WHAT ARE OUR CLIENTS SAYING“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.” - Arie Henkin, VP of Quality and Regulatory, Omniscient.“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.” – Jose Carrasquillo, Director of Technical Operations, Romark.

Listed skills include Java, C, Programming, C++, and 36 others.