DIFFRAC.SUITE - 21 CFR Part 11
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.
Speakers
Bixam Manthri
Satish Bagal
