21 CFR Part 11 Compliance for the LS 13 320 XR

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 ALCOA

  • Application: Active Pharmaceutical Ingredient, Excipients
  • Regulation: ISO 13320
  • Instrument set-up: SOP parameters pre-programmed into the instrument and automated
  • Sample ID: Sample ID and lot number can be tied to electronic record
  • Report: Secure PDF electronic file created by instrument
  • 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

Discover how the LS 13 320 XR can help with your laser diffraction and particle size analysis needs.

For additional information on 21 CFR Part 11 data compliance -- or to learn about Beckman Coulter's suite of instruments for data compliance and integrity -- click here.

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