Nitor Infotech provides computer system validation (CSV) services to ensure regulatory compliance and prevent issues. Their CSV approach includes validation planning, design verification, installation qualification, operational qualification, performance qualification, and code reviews. They offer end-to-end CSV as well as gap analyses, service consolidations, and validation of spreadsheets, enterprise applications, and PLC systems. CSV reduces risks and costs by documenting requirements for regulators and ensuring quality, compliance, and patient safety.

1. Nitor Infotech
Computer System Validation

2. Agenda
Why CSV?
CSV Service Offerings
CSV Implementation Approach
Benefits

3. 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 down
manufacturing facilities.
To reduce risk of financial and legal liabilities

4. 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

5. Service Offering
Offerings
End to end
computer
system
validation
CSV Gap
analysis
CSV service
consolidation
Prospective/R
etrospective
Harmonization
of CSV process
PLC validation
Spread sheet
validation
Enterprise
application
validation
Vendor
assessment

6. 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

7. 401-408, A-Wing, Pride Silicon Plaza,
Near Chaturshringi,S.B. Road,
Shivajinagar, Pune-411016,
Maharashtra, INDIA
Email: info@nitorinfotech.com
Tel : +91-20-41020202