Webinar Recording

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