James Shore

Articles by James Shore

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Software

Validating Software Without Losing Your Mind: A Risk-Based Approach Auditors Actually Accept

Why software validation continues to be one of the most persistent sources of audit findings and confusion.

February 27, 2026

The audit is moving along smoothly. Procedures are available, records are organized, and questions are answered without hesitation.

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The Quality Leaders Forum is a quarterly, editor-moderated fireside chat series hosted by Quality Magazine, featuring candid conversations with senior manufacturing and operations executives shaping enterprise-level quality.

Articles by James Shore

Validating Software Without Losing Your Mind: A Risk-Based Approach Auditors Actually Accept

Stay in the know with Quality’s comprehensive coverage of
the manufacturing and metrology industries.

Newsletters | Website | eMagazine

Articles by James Shore

Stay in the know with Quality’s comprehensive coverage ofthe manufacturing and metrology industries.

Newsletters | Website | eMagazine

Stay in the know with Quality’s comprehensive coverage of
the manufacturing and metrology industries.