What is Installation Qualification

Installation qualification is a documented verification process that the instrument or piece of equipment has been properly delivered, installed and configured according to standards set by the manufacturer or by an approved installation checklist.
installation qualification

Benefits of IQ in the Pharma industry

  • Reduced complexity
  • Maximized flexibility
  • Improved patient safety

Procedure to do Installation Qualification

  • prepare a checklist of all the components and parts including spare parts according to the purchase order and manufacture’s specifications
  • Record information for each actual part, component, item of auxiliary equipment, supporting facilities, and compare with the manufacturer’s specifications
  • Record Deviations to the System and Equipment
  • Prepare deviation report including justification of acceptance and impact on the function
  • Prepare an IQ Report
  • Submit that report to the QA for review and approval

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

GET IN TOUCH

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