Managing and Ensuring Data Integrity of E-Records within a Regulated Environment
Description:
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:
Introduction
| 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 |
Conclusion
Final Exam
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-125 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
A timely reminder of data integrity and its importance in what we do.
A must do course for anyone working in regulated IT.
An excellent course to explain the regulatory aspects to our IT folk.
A very timely course on a very important topic getting huge attention right now.
Related courses:
Laboratory Data Integrity and the Principles of ALCOA
Good Documentation Practices (GDocP) and Data Integrity
Implementing Compliant Systems in the Cloud
21 CFR Part 11 – Electronic Records
21 CFR Part 11 – Electronic Signatures
21 CFR Part 11 – An Introduction
Computer System Validation – Requirements: The Basis for Validation
Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5
Computer System Validation – The Regulated Software Life Cycle
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