Date recorded: May 23 2019

Duration: 39 minutes 05 seconds

This webinar follows on from Data Integrity, 21CFR Part 11 and the Mastersizer 3000. That webinar introduced the concepts of data integrity and showed how 21CFR Part 11 can be achieved on the Mastersizer 3000. In this webinar, we will discuss how the 21CFR Part 11 features can be used to ensure your laser diffraction work is 21CFR Part 11 compliant.


We will see how users making measurements add entries to the audit trail, both as comments and as logged actions. We will then look at how the audit trail can be viewed and exported from the Mastersizer 3000 software. The search features for the audit trail will be introduced and we will discuss which entries should be investigated further as part of regular data integrity review.

Table of contents
1. Data integrity and 21CFR: day-to-day use of the 21CFR features
03:31
2. Day-to-day use of 21CFR features
00:59
3. What is data integrity?
00:42
4. Data integrity and 21CFR Part 11
01:40
5. 21CFR part 11
01:27
6. Day-to-day user interactions
00:59
7. Day-to-day user interactions
03:01
8. Working with the audit trail
03:20
9. Working with the audit trail
01:02
10. Working with the audit trail
02:23
11. Reviewing the audit trail
02:29
12. Reviewing the audit trail
00:56
13. Reviewing the audit trail
02:04
14. Reviewing the audit trail
02:30
15. Video Demonstration
00:00
16. Reviewing the audit trail
00:46
17. General guidance
01:04
18. Additional materialprovided
00:36
19. Question & Answers
06:49
20. Video Demonstration
00:00
21. Question & Answers
00:44
22. For more details please contact your local Malvern Panalytical representative or visit www.malvernpanalytical.com
02:03