21 CFR Part 11 Compliant Instruments

2021.04.29 - 10.28

21 CFR Part 11 is a regulation that defines the criteria for ensuring trustworthy and reliable electronic records and electronic signatures in computerized systems of FDA regulated pharmaceutical industries. It is only meaningful for instruments connected to a computer and using software.

Several companies from the pharmaceutical industry have recently asked for 21 CFR Part 11 certification for instruments not connected to a PC, just using the instruments' firmware. In this webinar we look at the implications of this approach.

Content

  • The concept: Why would this be a good idea?
  • Background information
    • USP <1058>
    • Paper records
    • ALCOA and meta data
    • FDA warning letters
  • Conclusion: Why you should not do this. Expert opinion!
  • Automatic data flow: how it should be
  • Why LabX is a lean solution.

 

Duration: ca. 40 Minutes

29.4.2021 09:00 [ English ]
29.4.2021 17:00 [ English ]
28.10.2021 09:00 [ English ]
28.10.2021 17:00 [ English ]