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
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
· 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
· Determine how much testing is enough
· Discussion: How Does Software Testing Change with Software Complexity
VIII. Explore How Study Data are Examined Statistically
· Describe Good Automated Manufacturing Practices (GAMP®)
· Identify the five categories of software
· Examine ISO and IEEE standards
· Exercise: Analyze a Sample Data Set
IX. Overcome Common Documentation Pitfalls
· Identify software requirements and design documentation
· Develop computer and software validation protocols
· Write instructions for training users
· Use matrix documents for testing
· Write an effective summary report
· Discussion: Software Testing
X. Ensure Your Legacy Systems are FDA Compliant
· Determine what systems are legacy systems
· Perform retrospective validation
· Integrate with newer systems
XI. Validate Off-the-Shelf (OTS) Software
· Develop validation and verification protocol for OTS software
· Validate legacy and OTS systems
· Exercise: Essential Characteristics for CSV Documents and Teams
XII. Audit Software Vendors to Ensure Compliance
· Develop validation and verification protocol for OTS software
· Validate legacy and OTS systems
· Exercise: Essential Characteristics for CSV Documents and Teams
XIII. Analyze Current FDA Expectations and Inspection Trends
· Clarify the FDA’s interpretation of the scope and application of 21 CFR Part 11
· Avoid common deficiencies
· Discussion: Emerging Industry Standards
18(hours)