PTI - international

• Define how validation fits within the quality framework
• Incorporate key elements to achieve compliance
• Specify compliance process to include risk- based solutions
• Examine the challenges of common computerized systems
• Ensure system and data security and confidentiality

VI. Electronic Signatures

• Examine the requirements for electronic signatures
• Identify when signatures are required
• Current approaches for electronic signatures including the SAFE initiative

VII. Validate Computer and Software Systems

• Recognize current Part 11 and predicate rule requirements
• Use predicate rules to ascertain what needs to be validated
• Develop a Validation Plan utilizing commonly accepted practices including the GAMP® "V" model
• Use risk analysis to determine when enough validation is enough
• Examine why dynamic analysis alone may be insufficient to find all software defects
• Apply lifecycle methodology

Exercise: Create a Data Flow Diagram, Requirements and Test Criteria

VIII. FDA Inspection Issues

• Anticipate hot button issues for FDA inspectors
• Prepare for regulatory inspections of computer and software validation practices
• Examine 483s and Warning Letters