21 CFR Part 11 Related Products: Beckman Instruments for Data Integrity and Compliance


CytExpert Software for the CytoFLEX Flow Cytometer

Software tools can facilitate compliance with 21 CFR Part 11. Technical controls provide functions that ensure the reliability and integrity of electronic records and signatures. The CytExpert Electronic Record Management installation option for the CytoFLEX flow cytometer platform, has been designed to offer:

  • Controlled access to the closed system using passwords and permissions
  • Data integrity control using checksum and audit trails
  • Document control using signatures, signature hierarchy and file retention


LS 13 320 XR Laser Diffraction Particle Size Analyzer  Full View 

LS 13 320 XR Laser Diffraction Particle Size Analyzer

Offers methods to standardize analysis methods and reporting:
  • Guaranteed consistency & uniformity regardless of the number of applications, operators, instruments or locations
  • Elements from method setup to final print-out can be locked into user definable SOP
  • LS 13 320 XR offers a configurable security system for 21 CFR Part 11

Vi Cell MetaFLEX


Customer Responsibility: Compliance with 21 CFR Part 111 can only be met in connection with the operational environment.  The requirements for such an environment include:

  • Technical environment and data management
  • Training
  • Administration
  • Standard Operationg Procedures (SOP)

Learn more about 21 CFR Part 11 compliance using the Vi-CELL MetaFLEX