computer system validation
TRANSCRIPT
Nitor Infotech Computer System Validation
Agenda
Why CSV?
CSV Service Offerings
CSV Implementation Approach
Benefits
Why CSV?
Food and Drugs Administration regulation mandate the need to perform Computer System Validation
Failing an FDA audit can result in FDA inspection observation can result in 483 and shutting downmanufacturing facilities.
To reduce risk of financial and legal liabilities
Nitor CSV Approach
• Validation Report • Design Verification
• Installation Qualification
• Operation Qualification• Performance
Qualification
• Code Review
Planning and Definition
CSV Approach
• Validation Plan• Compliance Assessment
Deliverables
Validation Plan
Design Specification
Installation Qualification
Operational Qualification
IQ and OQ test scripts
Validation Summary Report
PQ Scripts
PQ Summary Reports
Requirement Traceability Matrix
(RTM)
Validation Report
Service Offering
Offerings
End to end computer
system validation
CSV Gap analysis
CSV service consolidation
Prospective/Retrospective
Harmonization of CSV process
PLC validation
Spread sheet validation
Enterprise application validation
Vendor assessment
CSV Benefits
Provides documentation required by FDA and other regulatory agencies
It ensure the product quality, Regulatory compline and patient safety
Nitor’s CSV approach ensures the high quality compliance in low cost
Nitor’s systematic computer system validation helps to prevent software problems from reaching to production environments
Computer system Validation reduce long-term cost by making it easier and less expensive to reliably modify software and revalidate the software changes
401-408, A-Wing, Pride Silicon Plaza,
Near Chaturshringi,S.B. Road,
Shivajinagar, Pune-411016,
Maharashtra, INDIA
Email: [email protected]
Tel : +91-20-41020202