Logo

Webinar Recording

Jack

 

 

 

DIFFRAC.SUITE
21 CFR Part 11 Webinar

Watch our educational webinar!

2 experts, Bixam Manthri and Satish Bagal discuss the use of DIFFRAC.SUITE 21 CFR Part 11 in more detail during this 60-min webinar.

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 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

Watch the recording here.


Best Regards,

Bruker AXS