| 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 www.malvernpanalytical.com |
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.
発表者
Sarennah Longworth-Cook
詳細
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)