PTI - international

I. Review Validation Requirements and Terminology

• Why validate?
• Locate the rules for validation
• Identify regulatory guidelines and guidance
• Explain validation in automatic, mechanical and electronic equipment
• Define qualification, verification and validation
• Review software qualification and common misconceptions

Discussion: Review Participants' Backgrounds and Personal Goals for the Course

II. Implement System Development Lifecycle Models and Activities

• Contrast software and hardware validation
• Examine the FDA Principles of Software Validation
• Review basics of hardware validation
• Review various System Development Lifecycle models
• Compare System Development Lifecycle models
• Define System Development Lifecycle activities

III. Define Regulatory Compliance Documentation for Automated Process Control Systems

• Validation Plan
• Risk Analysis
• Supplier Audits
• Requirement Specifications
• Design Specifications
• Test Planning
• Test Case Writing
• Test Execution & Documentation
• Change & Configuration Management
• Standard Operating Procedures
• Validation Summary Report
• Retirement

Exercise: Respond to the Urgent Request for Compliance Documentation

IV. Part 11, Risk Analysis and Supplier Audits

• Examine Part 11 and recent guidance documents
• Risk analysis and the FDA
• Role and use of Supplier Audits

V. Apply Validation to PLC, SCADA and DCS

• Determine "how much is enough?"
• What do I validate?
• Define user requirements as the key to validation
• Assess FDA philosophy towards software testing
• Describe software vs firmware vs ladder logic
• Role of risk analysis
• Qualification, commissioning and Good Engineering Practice