X-ray Diffraction (XRD) Webinar


Get ready for norm-compliance.

A- Part11 Requirements

  • Computer System Validation
  • Software Validation
  • Software Qualification IQ OQ PQ
  • Software Challenge Studies


Check List- USFDA

  • B11.10( a,…k)- Control for Closed systems
  • B11.30-Controls for Closed systems - Not applicable
  • B11.50-Signature Manifestations
  • B11.70- Signature linking
  • C11.100( a,b,c)- General requirements
  • C11.200( a,b)- Electronic Signature Controls
  • C11.300(a,b,c,d,e)- identification codes and passwords


Features of DIFFRAC.SUITE Software and Case Studies

  • Single Database for all the files methods, raw files and evaluated files
  • Multi User environment
  • Individual Windows logins
  • Files are tamperproof
  • General settings for user accounts
  • Signature Implementation for signing the data and reviewing the data as well

This one-hour webinar includes interactive sessions based on years of experience in the 21 CFR Part-11 field.


Bixam Manthri

Bixam Manthri obtained his Bachelor of Engineering in Instrumentation from Osmania University. He started working in Bruker India’s service support department from 2003. Currently, he is working as a regional service manager for Southern and Central India.

Satish Bagal

Satish Bagal, who has a Bachelor’s degree in Electronics and Telecommunication, started working in Bruker India’s service support department from 2007.