PTI - international

I. Introduction to Complying with Computer and Software Validation Requirements

• Examine why and how the federal government regulates the pharmaceutical and medical device industries
• Outline course goals
• Understand the importance of validation

Exercise: Discussion: Review Attendees' Backgrounds and Personal Experiences with Computer and Software Validation

II. Examine Software Design, Development and Verification

• Define the components of system development life cycles
• Outline major software development and validation deliverables
• Recognize which documents are most important in the eyes of FDA

III. Review Computer and Software Validation Fundamentals

• Determine the when and who of validating computers and software
• Review different types of computer validation
• Identify what needs to be validated
• Assess how much validation is enough
• Review the format and content of the validation plan
• Decide when to create a validation master plan

IV. Enhance Writing Skills for Software Requirements

• Explore FDA perspective on software requirements documents
• Define and manage requirements
• Analyze requirements to be sure they are correct, complete, and consistent

Exercise: Good Requirements and Good Specifications

V. Complete IQ/OQ/PQ

• Briefly examine the origins of computer validation
• Clarify the relationship to software verification
• Analyze the relationship to software validation
• Investigate common IQ/OQ/PQ documentation deficiencies

Discussion: Clarify Use of IQ/OQ/PQ

VI. Analyze Computer System Validation Regulations in the Device Industry

• Examine 21 CFR Part 820: Quality System Regulations
• Become familiar with Part 820.30: Design Controls
• Know which validation documents are required

VII. Examine Software Validation Testing

• Identify software validation test considerations
• Describe integration-level validation tests
• Analyze system-level validation tests
• Outline how to select test data
• Determine how much testing is enough

Discussion: How Does Software Testing Change with Software Complexity