Articles By Eric Larson

31. A Risk Management Approach For The Pharmaceutical Industry 10/14/2026

    Replacing fluorinated chemistries across pharma isn’t simple. Growing pressures make it critical to prioritize risks and take a sequenced, evidence-based approach to mitigation.

32. 10.13.26 -- New Insights For Medical Device Innovation 10/13/2026

    10/13/26 Med Device Online Newsletter

33. 10.11.26 -- Everyone Is Only Reading The MDR Half Of Europe's Reform 10/11/2026

    10/11/26 Med Device Online Newsletter

34. The Business Case For Electronic GxP Management 10/8/2026

    Spreadsheet-based quality systems carry costs that tend to be underestimated. Electronic GxP management shifts effort from routine compliance tasks toward quality improvement and patient safety.

35. The Return On Investment Of An Electronic Quality Management System 10/8/2026

    Time and cost estimates for document control, quality events, and training show where paper-based quality processes drain resources and what electronic systems could recover.

36. Your Quality Team Is Already Using AI To Draft Compliance Documents 10/8/2026

    Quality teams already use general-purpose AI for deviations and submission drafts without validation. Regulators expect governance, and the gap is an undocumented process step, not unreliable output.

37. Our Validation Approach 10/8/2026

    Computerized system assurance shifts most effort to the software vendor, leaving customers with a risk-based review of their own. It raises questions about which documentation still earns its place.

38. Is Your QMS Holding You Back From Achieving Continuous Compliance? 10/8/2026

    A scored diagnostic places a quality system on a four-tier maturity curve across five dimensions, showing where compliance runs reactively and what moving toward continuous readiness would take.

39. For Constant Audit Readiness And Complete Compliance Visibility 10/8/2026

    AI-driven gap analysis can scan an entire system in under an hour, mapping clause-level requirements across multiple standards and turning audit readiness from a scramble into continuous monitoring.

40. Complete Guide To Computerized System Compliance 10/8/2026

    The move from computerized system validation to assurance reframes how regulated companies adopt digital tools, favoring risk-based critical thinking and quality outcomes over paper-heavy compliance.