Complying with Computer and Software Validation Requirements
Agenda: Day One
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
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.