Webinar 2018 21CFRPart11Requirements

DIFFRAC.SUITE CFR Part 11

This webinar took place on June 08th 2018

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Overview

This 60-min webinar includes interactive sessions with Bixam Manthri and Satish Bagal, who have years of experience in the 21 CFR Part-11 field.

USFDA- 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 Part-11 S/w 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

Speakers

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