Lecture 15

Question 1

What is data integrity?

Answer 1

Data integrity refers to the completeness, consistency, and accuracy of information throughout its entire lifecycle, as defined by regulatory bodies like the FDA and EMA.

Question 2

Why is data integrity important?

Answer 2

Patient Safety and Drug Quality: Ensures the production of safe and effective medications that meet quality standards.
Regulatory Compliance: Critical for meeting regulatory requirements; non-compliance can result in FDA observations and market challenges.
Avoiding Issues: Lack of data integrity can lead to invalid results.
Trustworthy Data: Ensures reliable data to support informed decision-making.

Question 3

What are the 9 characteristics of ALCOA PLUS?

Answer 3

Attributable: Data must be traceable to its source, holding individuals accountable.
Legible: Data should be easily readable and understandable.
Contemporaneous: Data must be recorded at the time of the activity.
Original: Data entries should be unique and genuine.
Accurate: Data should be error-free and verified.
Complete: Records must contain all relevant information for the specific activity.
Consistent: Data should be stored and recorded in a way that allows easy retrieval.
Enduring: Data must be preserved for a defined period.
Available: Data should be readily accessible when needed.