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Beyond Compliance 2.04 Product Quality and Organizational Compliance

Beyond Compliance 2.04 Product Quality and Organizational Compliance. Daniel Riganati Johnson & Johnson Health Care Systems, Inc. November 16, 2004. A Recent Computer Validation Project…. Supply Chain Order Entry GMP system requiring CSV

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Beyond Compliance 2.04 Product Quality and Organizational Compliance

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  1. Beyond Compliance 2.04 Product Quality and Organizational Compliance Daniel Riganati Johnson & Johnson Health Care Systems, Inc. November 16, 2004

  2. A Recent Computer Validation Project… Supply Chain Order Entry • GMP system requiring CSV • Logistics & distribution for 14 different Rx and MD&D manufacturers • Electronic records • Budget: > $7 million • Duration: 10 months • Project team: > 50 persons • Validation team: 2 persons

  3. The Language of Compliance and Quality

  4. Quality … Beyond Compliance • Compliance • Conformance to regulatory requirements • Quality • Grade • Number of characteristics or features (requirements) • Conformance to requirements • All stakeholders • Needs, Wants and Expectations • “Fit for purpose” • No missing or incorrect requirements

  5. Keys to Success • Speak the language of your audience • Early involvement • Become a partner early v. a roadblock late • Ensure all stakeholders are represented • Including regulatory bodies • Incorporate regulations as product requirements • Quality is built in, not inspected in

  6. Benefits • Regulatory compliance • High product quality • Reduced risk • Reduced rework, resources, cost • Done right the first time • Improved time to market • Due to reduced rework and fewer missing or incorrect requirements • Increased revenue, profit

  7. Summary Product Quality and Regulatory Compliance… They’re not just the law… They’re good business.

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