SMARTTRANSVAL

Benefits

Value for you:

• Always up-to-date and validated software, accessible from any location
• Reduces report writing to a couple of minutes instead of days
• Simple, even for non-statisticians!
• Best-in-class decision making

Enables you to:

• Determine 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

Our statisticians provide support for any questions concerning the use of the software and the processing of your data.

Features

• Use of Total Analytical Error (TAE) concept (i.e. combine bias and precision)
• Up to 5 “receiver” labs analyzed in one report
• Use of β-expectation Tolerance Interval to manage the risk in routine analysis such as suggested in USP 1210
• Generate an e-CTD report within minutes, in full compliance with authority expectations (ICH Q2, FDA, ISO, EMA, WHO, USP 1220, USP 1210 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
• 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