For Individuals
For Companies
Events
About
Contact
LOGIN

Skip to content

Safe AI in Pharmaceuticals: Validation, Data Integrity and Regulated AI in Life Sciences

Where AI Is Used Across Discovery, Trials, Manufacturing and Safety

Quiz: Where AI Is Used Across Discovery, Trials, Manufacturing and Safety

GxP Boundaries: Which AI Uses Are Regulated

Quiz: GxP Boundaries: Which AI Uses Are Regulated

Computerised System Validation Applied to Machine Learning

Quiz: Computerised System Validation Applied to Machine Learning

Data Integrity Principles and Audit Trails for AI Systems

Quiz: Data Integrity Principles and Audit Trails for AI Systems

Risk Based Validation and Supplier Assessment

Quiz: Risk Based Validation and Supplier Assessment

AI in Clinical Trial Design, Recruitment and Monitoring

Quiz: AI in Clinical Trial Design, Recruitment and Monitoring

Regulatory Expectations for AI in Marketing Authorisations

Quiz: Regulatory Expectations for AI in Marketing Authorisations

Pharmacovigilance: Signal Detection and Case Processing With AI

Quiz: Pharmacovigilance: Signal Detection and Case Processing With AI

Manufacturing Process Control and Batch Release Decisions

Quiz: Manufacturing Process Control and Batch Release Decisions

1 of 2

Previous Lesson

Quiz: GxP Boundaries: Which AI Uses Are Regulated

Safe AI in Pharmaceuticals: Validation, Data Integrity and Regulated AI in Life Sciences
GxP Boundaries: Which AI Uses Are Regulated
Quiz: GxP Boundaries: Which AI Uses Are Regulated

Time limit: 0

Quiz Summary

0 of 5 Questions completed

Questions:

Information

You have already completed the quiz before. Hence you can not start it again.

Quiz is loading…

You must sign in or sign up to start the quiz.

You must first complete the following:

Results

Quiz complete. Results are being recorded.

Results

0 of 5 Questions answered correctly

Your time:

Time has elapsed

You have reached 0 of 0 point(s), (0)

Earned Point(s): 0 of 0, (0)
0 Essay(s) Pending (Possible Point(s): 0)

Categories

Not categorized 0%

Review
Answered
Correct
Incorrect

Question 1 of 5

1. Question

Which of the following AI applications must comply with GMP regulations?

An AI tool used to schedule employee shifts
Correct Incorrect Correct answer

An AI system that monitors manufacturing equipment for anomalies affecting drug quality
Correct Incorrect Correct answer

An AI chatbot that answers employee inquiries
Correct Incorrect Correct answer

An AI system that analyses market trends for competitive intelligence
Correct Incorrect Correct answer

Correct / 1 Points

Incorrect / 1 Points
Question 2 of 5

2. Question

What is the key principle determining whether an AI application falls under GxP regulation?

The cost of implementing the AI system
Correct Incorrect Correct answer

The size of the pharmaceutical company using the AI
Correct Incorrect Correct answer

Whether the AI output directly affects product quality or patient safety
Correct Incorrect Correct answer

The type of data the AI system processes
Correct Incorrect Correct answer

Correct / 1 Points

Incorrect / 1 Points
Question 3 of 5

3. Question

Which of the following is an example of an AI application that must comply with clinical data management GxP requirements?

An AI tool that manages email responses to customer inquiries
Correct Incorrect Correct answer

An AI system that identifies data inconsistencies or outliers in clinical data
Correct Incorrect Correct answer

An AI system used for predicting batch outcomes during manufacturing
Correct Incorrect Correct answer

An AI tool that provides recommendations for clinical trial design
Correct Incorrect Correct answer

Correct / 1 Points

Incorrect / 1 Points
Question 4 of 5

4. Question

According to the lesson, which of the following AI systems is most likely to be outside the scope of GxP regulation?

An AI system that predicts batch outcomes during drug manufacturing
Correct Incorrect Correct answer

An AI tool that performs automated inspection of packaging or labeling
Correct Incorrect Correct answer

An AI chatbot that handles employee scheduling
Correct Incorrect Correct answer

An AI system that flags potential protocol deviations in clinical data
Correct Incorrect Correct answer

Correct / 1 Points

Incorrect / 1 Points
Question 5 of 5

5. Question

What must be maintained for AI systems used in clinical data management to meet GxP requirements?

Only audit trails and validation documentation
Correct Incorrect Correct answer

Detailed records of performance and validation activities
Correct Incorrect Correct answer

Automatic email notifications to clinical researchers
Correct Incorrect Correct answer

Real-time clinical data access for all staff members
Correct Incorrect Correct answer

Correct / 1 Points

Incorrect / 1 Points

Login

Accessing this course requires a login. Please enter your credentials below!

Username or Email Address

Password

Remember Me

Continue with Facebook

Continue with Google

Lost Your Password?

Register

Don't have an account? Register one!

Register an Account

Ready to Lead the AI Revolution?

Join hundreds of executives transforming their careers with Tesseract Academy.

Explore Individual Learning

© 2026 Tesseract Academy. All Rights Reserved.