For Compliance Leaders

FDA Authority and the Vendor's Role, Who Is Accountable

Where FDA's authority actually sits when a vendor's software is used in a GxP process, and what that means for accountability.

What Is a Release Assurance Summary

What a release assurance summary is, what it should contain, and why it matters more under a risk based CSA approach.

Building a Defensible Audit Trail Across Vendors

How to maintain a defensible audit trail when GxP relevant work spans multiple vendor systems that were never built to talk to each other.

Board Level Risk, the Cost of an Unvalidated AI Tool

How to frame the risk of an unvalidated AI tool in GxP use for a board or executive audience, beyond the compliance detail.

Questions a VP of Compliance Should Ask Before an AI Pilot Begins

The questions a VP of Compliance should ask before a team starts piloting an AI tool anywhere near a GxP process.

Excel Spreadsheets in Regulated Environments, the Hidden Risk

Why Excel spreadsheets keep showing up in audit findings for regulated companies, and what to do about the ones already in use.

Liability, Who Is on the Hook When an AI Model Changes

Where liability actually sits when a vendor's AI model changes and its behavior shifts inside a GxP regulated process.

Making the Internal Case for Validation Budget

How to make the internal case for validation budget to leadership that does not see the cost of validation debt until it surfaces.

What Changes for Compliance Teams When FDA Finalizes CSA Guidance

What is likely to change for compliance teams once FDA's Computer Software Assurance guidance moves from draft to final.