What if There Were no Part 11?

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Presentation transcript:

What if There Were no Part 11? A Value-Based Perspective Mark P. Roache

An Introduction KMI/PAREXEL LLC Mark Roache CRO and Consulting Life-Sciences Multi-National Business, Compliance and Validation Consulting Mark Roache Director, Account Management Client Value and Strategy

Objectives Reset Perspective Recommendations for Industry Suggestions for Useful Regulation

Our Industry is Being Squeezed Price Pressures Business: M&A Maturing Time to Market Compliance New Reg’s SOX, HIPAA Efficiency Enforcement

IT Can Help Meet the Challenges Data Capture, Analysis Knowledge Transfer Mfg Efficiency Change, AE’s Documents& Workflow IT Infrastructure Applications Software 21 CFR Part 11 R&D Clinical Regulatory Marketing Scale-up & transfer Manufacture & Distribute Retire Monitor and Improve

Why Does Part 11 Get in the Way? Technical focus on Compliance Over-interpretation of regulation Lack of perceived value Inflated estimates of added costs

Getting Value from IT Business Processes Server Apps and Processes Defined business process and requirements (Predicate Rules) Business Processes Server Apps and Processes Client Footprint Quality assurance on technical solution (AKA Validation) Operating Sys and Support Apps Servers Network & RF Workstations & Handhelds Physical Environment Robust and complete procedures (AKA Governance) IT Asset Management Procedures

How do controls support value? Control should be appropriate Context based - Business Process & Technology Documented - Active Exclusion Scope and extent - Risk/Value

How to Quantify Risk and Value? Failure Discoverable? High Impact Failure Modes Regulations Med. Impact System Characteristic Impact Assessment Low Impact Impact of Failure System Barriers

Analysis of Risk and Value enables decisions now The Pareto Principle 80% of the risk comes from 20% of the process or…. 80% of the value comes from 20% of the system Benefits: Cover what’s really needed Avoid overspend and scope creep

There is insight in how we summarize risk and value… a longer-term view IT Domain Platform/ Performance Security Virus/ Patches Backup Change/Config Ops Domain QA Domain Business Processes ERP LIMS EDMS Clinical PDM/PLM

Essential Elements for Value & Compliance Defined requirements Optimized business practice Governed by predicate rules Acceptance & Validation Driven by Risk/Value Adequate & complete Risk/Value Analysis Determines scope and extent Compliance and business risks Active exclusion IT Governance Sustainability Applicability

Essential Elements for Regulation Defined requirements Predicate Rules Acceptance & Validation Adequate & complete Risk/Value Analysis Should be required Record process/rationale Active exclusion essential IT Governance Just another quality system Training Documentation

What does it mean? Industry Regulators Focus on processes Operations Refocus on value and ROI QA, Compliance Compliance in context IT Implement Quality Systems Regulators Focus on processes Implementation Governance Use Risk/Value as pivot Shift Approach Knowledgeable Discretionary

Thank You! Mark P. Roache Director, Account Management Cellphone: (650) 714 1252 Email: Mark.Roache@PAREXEL.com