Data integrity and 21CFR: day-to-day use of the 21CFR features

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00:00:00 Data integrity and 21CFR: day-to-day use of the 21CFR features
00:03:31 Day-to-day use of 21CFR features
00:04:30 What is data integrity?
00:05:12 Data integrity and 21CFR Part 11
00:06:52 21CFR part 11
00:08:19 Day-to-day user interactions
00:09:18 Day-to-day user interactions
00:12:19 Working with the audit trail
00:15:39 Working with the audit trail
00:16:41 Working with the audit trail
00:19:04 Reviewing the audit trail
00:21:33 Reviewing the audit trail
00:22:29 Reviewing the audit trail
00:24:33 Reviewing the audit trail
00:27:03 Video Demonstration
00:27:03 Reviewing the audit trail
00:27:49 General guidance
00:28:53 Additional materialprovided
00:29:29 Question & Answers
00:36:18 Video Demonstration
00:36:18 Question & Answers
00:37:02 For more details please contact your local Malvern Panalytical representative or visit

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.


Sarennah Longworth-Cook

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Who should attend?
Anyone with responsibility for Mastersizer 3000 working within a 21CFR Part 11 compliant environment
Anyone who reviews audit trails for Mastersizer 3000

Why attend?
To understand the audit trail functions
To learn how to search the audit trail
To learn which entries in the audit trail require investigation (before the auditors arrive)