What is Computer System Validation

Computer system validation is the process of documenting that a computer system match a set of defined system requirements. It provides documented evidence that software applications meet their intended uses by testing regulated functional processes as well as requirements related to electronic records and electronic signatures.

computer system validation

Benefits of CSV in the Pharma industry

  • Legal compliance with the FDA
  • Reduces compliance risks
  • Discovers defects before a system build goes live
  • Provides companies with continuous improvement
  • Maximizes system efficiency

Computer System Validation classic “V Diagram”

computer system validation classic v diagram

Services

We are Specialised in delivering the following Automation Services

1

Control Module Software Design Specification , Configuration and Testing

2

Common Composite (EM/CM) Design Specification

3

Phase Class Software Design Specification , Configuration and Testing

4

Equipment Module Class Software Design Specification , Configuration and Testing

5

Phase Software Design Specification and Coding

6

Graphic Design Specification and Configuration

7

CMI Software Design Specification and Configuration

8

Internal Testing of EM and Phases

9

Unit Module Software Design Specification and Coding

10

Recipe Testing

11

Control Module Configuration

12

Interlock Configuration and Testing

13

IQ and OQ for Solvent Transfer Sequence

14

DSATP Protocol Creation

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ABOUT US

Based in Ireland We are Leading in Automation Services for Pharmaceutical Companies in Computer System Validation , Installation Qualification , Operational Qualification and Process Verification