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 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

November 16, 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

November 16, 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

November 16, 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

November 16, 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

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