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

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

3. November 16, 20043 The Language of Compliance and Quality Regulatory ComplianceProject/Quality Mgt l Regulator l Stakeholder l Regulation l Mandatory requirement l Regulatory compliance l Conformance to requirements l Regulate l Review, test, monitor, manage l Documentation l Deliverables l Risk l Gaps, unmet requirements l Audit l Process review

4. November 16, 20044 Quality … Beyond Compliance l Compliance –Conformance to regulatory requirements l 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. November 16, 20045 Keys to Success l Speak the language of your audience l Early involvement –Become a partner early v. a roadblock late l Ensure all stakeholders are represented –Including regulatory bodies l Incorporate regulations as product requirements –Quality is built in, not inspected in

6. November 16, 20046 Benefits l Regulatory compliance l High product quality l Reduced risk l Reduced rework, resources, cost –Done right the first time l Improved time to market –Due to reduced rework and fewer missing or incorrect requirements l Increased revenue, profit

7. November 16, 20047 Summary Product Quality and Regulatory Compliance… Theyre not just the law… Theyre good business.