21 CFR Part 11 Compliance for the LS 13 320 XR Particle Size Analyzer

LS 13 320 XR Laser Diffraction Particle Size Analyzer with PIDS technology

How the LS 13 320 XR particle size analyzer help you comply with 21 CFR part 11

  • QC Step: Raw Material
  • Application: Active Pharmaceutical Ingredient, Excipients
  • Regulation: ISO 13320
  • Attributable: Multi-level, individual user name and password for all users
  • Legible: Legible, secure PDF export as well as audit trail and measurement results
  • Contemporaneous: Secure PDF created on day of sample analysis
  • Original: Original electronic record created directly from the instrument
  • Accurate: SOP parameters pre-programed into the instrument and automated