At Medtronic, Cindy and Joe are responsible for the characterization of known and unknown compounds. When they needed to upgrade their instruments several years ago they also built their requirements for the analysis software they wanted to find and deploy:

  • Instrument vendor and data format agnostic
  • Integrated with existing ELN and LIMS
  • Traceability (audit trail, versioning etc.) for CFR21 Part11 and GxP compliance

In this presentation these analysts discuss LC/MS-based compound characterization of extractables and leachables supported by effective data management.