Confidence Beyond Compliance

Your focus: method transfer

Your objectives:

  • Assess if a method can be transferred from a “sender” lab to one or several “receiver” labs according to the tolerance interval approach
  • Generate stand-alone transfer reports on the transfer of quantitative analytical method
  • Assess the risk of being out of specification at the new lab

Introducing Transval

  • Use of Total Error and tolerance interval concepts
  • Up to 5 “receiver” labs analyzed in one report
  • Use of β-expectation Tolerance Interval to manage the risk in routine analysis
  • Generate an e-CTD compliant report within minutes, in full compliance with authority expectations (ICH Q2, FDA, ISO EMA, WHO and USP 1224)
  • Suitable for GxP use: fully validated according to the GAMP5 guidelines and 21 CFR part 11 compliant
  • Decision-making tool: one graph = one decision
  • Our statisticians provide a support (hotline) for any questions concerning the use of the software and the processing of your data
  • Software as a Service (SaaS) application:
    • no installation required: no need to validate the system on site
    • no maintenance costs
    • can be accessed from any location
    • always the latest version available, free of charge