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computer system validation

1 Feb 2022

Computer System Validation

Computer system validation is the process of documenting that a computer system meets 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.

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installation qualification

1 Feb 2022

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.

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operational qualification

1 Feb 2022

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

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process verification

1 Feb 2022

Process Verification

process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

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Services

We are Specialised in delivering the following Automation Services

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Control Module Software Design Specification , Configuration and Testing

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Common Composite (EM/CM) Design Specification

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Phase Class Software Design Specification , Configuration and Testing

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Equipment Module Class Software Design Specification , Configuration and Testing

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Phase Software Design Specification and Coding

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Graphic Design Specification and Configuration

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CMI Software Design Specification and Configuration

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Internal Testing of EM and Phases

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Unit Module Software Design Specification and Coding

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Recipe Testing

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Control Module Configuration

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Interlock Configuration and Testing

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IQ and OQ for Solvent Transfer Sequence

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DSATP Protocol Creation

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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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