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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

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Quiz: Risk Based Validation and Supplier Assessment

Safe AI in Pharmaceuticals: Validation, Data Integrity and Regulated AI in Life Sciences
Risk Based Validation and Supplier Assessment
Quiz: Risk Based Validation and Supplier Assessment

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Question 1 of 5

1. Question

What is the primary purpose of applying a risk-based approach to AI validation in pharmaceutical manufacturing?

To reduce the cost of validation activities across all system components
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To focus validation efforts on areas where AI systems could cause significant harm or deviation
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To ensure that AI systems are always updated with the latest technology
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To guarantee that all AI algorithms meet international regulatory standards
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Question 2 of 5

2. Question

According to ISO 13485 clause 7.4, what must be included in the validation plan regarding risk categories?

Only computational errors and data integrity issues
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Potential data integrity issues, algorithm bias, or computational errors
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The supplier's financial performance and market share
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The number of clinical trials conducted by the organisation
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Question 3 of 5

3. Question

Which of the following is NOT part of the supplier assessment framework for AI systems?

Technical capabilities including algorithm development and data processing
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Data handling practices such as storage and access controls
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The supplier's marketing budget and advertising strategies
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Regulatory compliance history and documentation support
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Question 4 of 5

4. Question

What is one key requirement of ISO 13485 clause 8.2 for supplier evaluation?

The supplier must provide free software updates for life
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The supplier must demonstrate compliance with data protection legislation
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The supplier must have a branch office in every country
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The supplier must offer training courses for staff
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Question 5 of 5

5. Question

Which clause of ISO 13485 addresses monitoring and measurement activities related to AI validation?

Clause 9.1
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Clause 7.4
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Clause 8.2
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Clause 6.3
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