Choose one of the topics -->
Executive Compliance Consulting for IT-Compliance
• Analysis of Regulatory Compliance Validation Requirements for Computerized Systems
• Executive Management Briefing
• IT Validation Policy and Security Policy – Definition and Development (IT Validation and IT Security)
• Structuring and Implementation of Collection-, Evaluation- and Planning Methods in the Validation Process of Computerized Systems (IT Validation Master Plan)
• 21 CFR Part 11 Assessment and GAP Analysis (Tool Support through the use of the IQC Part 11 Database)
• Regulatory Compliance Status Analyses
• Inspection Preparation / Inspection Support
• Support with correct reaction to and processing of potential Inspectional Observations Reports (Form 483, Warning Letter)
|
|
| | Computer Regulatory Compliance | |
|
