What is Operational Qualification

Operation Qualification is an essential process during the development of equipment used by pharmaceutical companies Operational Qualification can simply be defined as a series of tests which ensure that equipment and its sub-systems will operate within their specified limits consistently and dependably
operational qualification

Benefits of OQ in the Pharma industry

  • Makes sure that each screen accepts the appropriate data
  • Makes sure that an item can be moved through an entire workflow
  • Makes sure that system security has been properly implemented
  • Makes sure that all technological controls for compliance with 21 CFR 11 are functioning as expected

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

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