Complying with Computer and Software Validation Requirements
Agenda: Day Two
VIII. Explore How Study Data are Examined Statistically
- Describe Good Automated Manufacturing Practices (GAMP®)
- Identify the five categories of software
- Evaluate software validation methodologies
- 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
- Ensure traceability and archive efficiently
- Develop compliant SOPs
- 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
- Identify FDA expectations
- 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
- Identify FDA expectations
- 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
- Identify the latest FDA trigger points
- Avoid common deficiencies
Discussion: Emerging Industry Standards
GAMP® is a registered trademark of ISPE. Please visit www.ispe.org for more information.
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.