Why do IT Companies fear Pharma CSV Requirements!

1. CSV | SDLC
End result is the same
Aniruddha Mehta

2. THE BIG COMPARISION
The big similarity between Pharma and IT
Industry.

3. High Level Steps
Requirements Design Configure Test Maintenance
User Requirements
Functional Requirements
Risk Analysis/Impact
Analysis
System Design
Hardware
Requirements
Business Design
Coding,
Customisation,
Integration,
Configuration
Installation
Qualification
Operational
Qualification
Performance
Qualification
Tracebility Matrix
Risk Assesment
Validation Summary Report
Sounds Similar !

4. Category 4
Configured Products
Category 3
Non- Configured Software
Categorization
Category 1
Infrastructure Software
Hardware Category 2
Custom built Hardware Components
Hardware Category 1
Standard Hardware Components
Category 5
Custom Applications