Software issues

• Who does the burden of validation fall on?

  • Vendor: can provide a validation package but is this enough
  • End user: What degree of testing is required?

• Do we need to ensure 21CFR 11 compliance

• Vendors are aware of these issue and some have begun to address it

  • Bomem: process FT-NIR software Enablir
  • SpectrAllaince: process UV/vis software NovaPack

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