Data Integrity (ALCOA)

Data Integrity Awareness: CSV Best Practices

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.

CEU Credits: 0.1

Course Code: ELM-154

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.1

Effective Date: 08/13/2021

Curriculum for this course

Program Introduction

Course Introduction

Learning Objectives

Overview: Data Integrity Awareness

Who Should Take This Program?

CSV Best Practices

CSV: Attributable

CSV: Legible

CSV: Contemporaneous

CSV: Original

CSV: Accurate

CSV: Complete

CSV: Consistent

CSV: Enduring

CSV: Available

Interactive Scenario

CSV Interactive Scenario

Conclusion

Final Assessment

Revision History

v1.1 Minor update on 12/09/2022 to remove glossary slide, update help/navigation slide and fix font issue.

v1.0 Course released in 2021

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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