Data Integrity Awareness: CSV Best Practices
Description:
Computer systems validation (CSV) is an area of high focus by regulators. In this course, we’ll discuss CSV best practices in relation to ALCOA+. As we have seen with some of the FDA Warning Letters that we’ve covered in previous courses in this data integrity awareness program, inspectors will check to see that the software is validated to have the proper level of control over the corresponding data consistent with ALCOA+ principles.
Curriculum for this course:
Program Introduction
| Course Introduction | 1 min 01 secs |
| Learning Objectives | 1 min 30 secs |
| Overview: Data Integrity Awareness | 1 min 21 secs |
| Who Should Take This Program? | 1 min 25 secs |
CSV Best Practices
| CSV: Attributable | 1 min 05 sec |
| CSV: Legible | 1 min 45 secs |
| CSV: Contemporaneous | 1 min 08 secs |
| CSV: Original | 1 min 10 secs |
| CSV: Accurate | 1 min 48 secs |
| CSV: Complete | 1 min 24 secs |
| CSV: Consistent | 1 min 30 secs |
| CSV: Enduring | 1 min 09 secs |
| CSV: Available | 1 min 30 secs |
Interactive Scenario
| CSV Interactive Scenario | 5 mins |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-154 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Another great additional to the Data Integrity Awareness Program. This course makes it extremely easy to understand how exactly ALCOA+ relates to CSV.
This course and the other courses in this program are now mandatory for our global Data Integrity training program.
Related courses:
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