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Is the Pharmaceutical Industry Missing Out on FMEA?

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My June 2025 article, “How to Avoid FDA Warning Letters,” points out that inadequate corrective and preventive action (CAPA) is a major reason

A Guide to 21 CFR Part 11 and Annex 11 Compliant Signatures

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We’d be willing to bet your key collaborators aren’t all in the same building. Your team members, contract partners, clients, and suppliers are likely scattered across the globe.

Business Needs to Remember the Forgotten Stakeholders

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When businesses talk about customer experience, the conversation almost always focuses on the end user. That’s understandable, but dangerously narrow.

Sales vs. Service

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A recent company meeting revealed what management called a “handoff problem.” The sales team would close deals, then toss them over the wall to the service team, which would promptly fumble the relationship because they didn’t understand what had been promised or why

Shock to the System: Reviving Decision-Making in a VUCA World

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Your market is shifting, your competitor just pulled ahead, and the one person who could execute the next move has resigned. You can’t get more data fast enough, yet the window to act is closing.

4 Ways to Manage Supply Chain Disruptions Before They Happen

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Small to midsize manufacturers are facing mounting pressure from unpredictable supply chain disruptions.

Lessons From GAMP 5

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Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms.

The Growth Equation

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Nano Tools for Leaders, a collaboration betwe

Stress: A Productivity Killer Hiding in Plain Sight

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At Ramirez & Co., a midsize business with decades of wins, leadership thought its biggest challenges were competitors, technology, and the market. Close, but no cigar.

Preparing Your Quality System for AI-Enabled Asset Management

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What if your quality system could detect and initiate corrective actions for equipment deviations before they affect product quality?

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