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Part 5: Moving from AI Strategy to Implementation
Laying the Organizational Groundwork for AI in Regulated Life Sciences
Jun 18
•
Kevin Shea
2
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Part 5: Moving from AI Strategy to Implementation
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Part 4 – Adapting Validation for AI
Extending CSV and CSA for Systems that Learn and Adapt
Jun 6
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Kevin Shea
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Part 4 – Adapting Validation for AI
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May 2025
Implementation Readiness: A New Foundation for GxP System Success
Evolving the Pre-Project Phase for GxP, AI, and Real-World Complexity
May 28
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Kevin Shea
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Implementation Readiness: A New Foundation for GxP System Success
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Part 3: Governance Models for AI in Regulated Teams
Building scalable oversight, ownership, and risk alignment in dynamic AI environments
May 27
•
Kevin Shea
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Part 3: Governance Models for AI in Regulated Teams
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Part 1: The Strategic Imperative: Why Life Sciences Organizations Need a Deliberate AI Strategy
AI is no longer optional — and neither is a strategy to govern it.
May 27
•
Kevin Shea
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Part 1: The Strategic Imperative: Why Life Sciences Organizations Need a Deliberate AI Strategy
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Part 2: Fit for Purpose: Aligning AI Strategy to Your Company
Building AI strategies that reflect function, regulatory risk, and organizational maturity
May 23
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Kevin Shea
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Part 2: Fit for Purpose: Aligning AI Strategy to Your Company
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A Hidden Barrier to CSA Implementation: Why Digital Validation Is the Missing Link
From Ideas to Practice: Enabling Risk-Based Validation Through Digital Infrastructure
May 7
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Kevin Shea
1
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A Hidden Barrier to CSA Implementation: Why Digital Validation Is the Missing Link
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April 2025
Evolving Validation for AI-Enhanced Systems
Some Reflections on the Path Forward
Apr 24
•
Kevin Shea
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Evolving Validation for AI-Enhanced Systems
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The Hidden Costs of Manual Validation in Life Sciences
Part 1 of the "Transforming Validation in Life Sciences" Series
Apr 22
•
Kevin Shea
1
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The Hidden Costs of Manual Validation in Life Sciences
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The Strategic Imperative: Why Life Sciences Organizations Need a Deliberate AI Strategy
AI is no longer optional — and neither is a strategy to govern it.
Apr 8
•
Kevin Shea
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The Strategic Imperative: Why Life Sciences Organizations Need a Deliberate AI Strategy
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February 2025
Risk-Based Validation in Cloud-Based, Multi-Tenant GxP Systems
Establishing a strategic validation approach that relieves your client's validation overhead
Feb 20
•
Kevin Shea
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Risk-Based Validation in Cloud-Based, Multi-Tenant GxP Systems
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From Risk-Based Monitoring to Risk-Based Validation
Prioritizing Resources for System Validation and Data Integrity in Life Sciences
Published on Driftpin Consulting Newsletter
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Feb 19
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