Managing and Ensuring Data Integrity of E-Records within a Regulated Environment


This course has been created for anyone who is interested in learning more about managing and ensuring integrity of e-records within a regulated environment. If you would like to expand your knowledge of e-record integrity, but find it difficult to move forward in the process, this course is the perfect starting point. Our course will bring you up to speed with the world of e-record data integrity very quickly, explaining the basics of what is involved. The purpose of this course is to provide an easy launchpad to allow learners to search for more detailed information when it is needed.

Curriculum for this course:
Overview 55 secs
Learning objectives 45 secs
Who should take this course? 1 min 10 secs
Course modules 1 min 01 secs
Module 1: Industry Regulations
The starting point 1 min 10 secs
Definitions 1 min 13 secs
US FDA 1 min 22 secs
Eudralex 1 min 01 secs
More important definitions 1 min 33 secs
Records Vs data 1 min 23 secs
Key points to note 1 min 38 secs
Module 2: Computer Systems
Key regulations 1 min 15 secs
Risk 1 min 25 secs
Module 3: Requirements for Computer Systems
The key areas 1 min 28 secs
Security and protection 1 min 31 secs
Accuracy & validity 1 min 45 secs
Audit trails & metadata 1 min 41 secs
Access and presentation 1 min 51 secs
“Open” Vs “Closed” Systems 1 min 37 secs
Module 4: Deployment
Procedural requirements 1 min 30 secs
SOPs and work instructions 1 min 27 secs
Validation of computer systems 1 min 48 secs
Module 5: Special Topics
Overview 49 secs
Archival 1 min 39 secs
Backup file Vs backup copies 1 min 41 secs
Backup copies 1 min 50 secs
Data migration 1 min 46 secs
Final Exam

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