Case Studies

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Pfizer:

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Reduced open complaints from 7,000+ to under 4,500 in 6 months — enabling compliance with a key performance target.

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Olympus:

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Developed verification checklists for global complaint records and improved timeliness of MDR reporting. Supported 3rd Party suppliers in the EU with compliance to company global operating standards.

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ACell:

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​Led CAPA/NCR process redesign; improved closure timelines by 40%. Achieved zero findings in ISO 13485 recert audit in 2019.

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Avertix Medical:

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​Led FDA inspection remediation and QMSR harmonization by implementing document control improvements, completing CAPA effectiveness verification, and strengthening electronic quality system workflows to achieve audit readiness.

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West Pharmaceutical Services:

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​Developed and implemented controlled document and chain-of-custody processes supporting a manufacturing transfer, ensuring compliant sample traceability, batch record integration, and FDA/ISO 13485–aligned document control.

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