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.

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
Final Assessment

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