6/11/04Part 11 Public Meeting1 Risk-Based Approach Scott M Revolinski Washington Safety Management Solutions Carolyn Apperson-Hansen Cleveland Clinic Foundation

6/11/04Part 11 Public Meeting2 Major Points Use of risk based evaluation of electronic records systems Defining which electronic records are Part 11 electronic records

6/11/04Part 11 Public Meeting3 Major Points Use of risk based evaluation of electronic records systems Defining which electronic records are Part 11 electronic records

6/11/04Part 11 Public Meeting4 Existing Risk Guidance Use of COTS software in medical devices

6/11/04Part 11 Public Meeting5 Existing Risk Guidance COTS software in medical devices guide: –Basic Validation Documentation –Residual Risk Discussion

6/11/04Part 11 Public Meeting6 Risk Assessment Difficulties Most electronic records cannot be easily related to human safety categories: –major, moderate, minor Failure probability for software cannot be defined

6/11/04Part 11 Public Meeting7 General Risk Guide (draft) Risk Management as an Integral Part of the Quality Management System, SG3 / N15R6 (draft) Using Failure Mode and Effects Analysis (FEMA) techniques leads to a risk index. This is used to categorize the significance of various hazards

6/11/04Part 11 Public Meeting8 What’s Missing Relationship between electronic records and human safety Evaluation of electronic record hazard probabilities and consequences Basis for judging robustness of risk mitigation controls

6/11/04Part 11 Public Meeting9 Systems Approach Evaluate association between product quality / human safety and System under consideration Examine electronic records use within System Identify electronic record security and integrity hazard scenarios Establish multiple layers of risk mitigation controls commensurate with hazard probability and consequences

6/11/04Part 11 Public Meeting10 Risk Assessment Summary In re-evaluating the risk-based approach to Part 11 requirements consider providing: –an approach to estimate the relationship between electronic records and human safety (e.g., FMEA – Systems Approach) –types of risk mitigation controls (e.g., layers of procedural and / or physical barriers) –basis for accepting residual risk

6/11/04Part 11 Public Meeting11 Major Points Use of risk based evaluation of electronic records systems Defining which electronic records are Part 11 electronic records

6/11/04Part 11 Public Meeting12 Existing Application Guidance Scope and Application Guide for Part 11

6/11/04Part 11 Public Meeting13 Application Difficulties Most predicate rules were written before use of computers for records management Predicate rule requirements for Part 11 issues aren’t addressed Few electronic records have direct links to product quality or human safety yet Part 11 application is anticipated

6/11/04Part 11 Public Meeting14 Risk-Based Systems Approach Business risk is the inappropriate use of narrow Part 11 scope Systems approach to determine use of electronic records and potential regulatory impacts Justification documentation

6/11/04Part 11 Public Meeting15 Application Summary In re-evaluating the scope of Part 11 application consider providing: –some examples of when electronic records could be considered Part 11 records and when they are not (when not specifically identified in the predicate rules) –basis for deciding what is significant to product quality / human safety

6/11/04Part 11 Public Meeting16 Contact Information Scott Revolinski Washington Safety Management Solutions 2131 S. Centennial Avenue Aiken, SC Carolyn Apperson-Hansen Cleveland Clinic Foundation 9500 Euclid Avenue Cleveland, Ohio