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Commissioning and Qualification

Vigorous testing, validation and quality assurance...

The true test of the success of Automation, MES & Lab software is when it arrives on site. Ensuring the commissioning, qualification and validation (CQV) process runs smoothly is critical to project success and it is a journey that starts early in the project lifecycle with the CSV plan.

Our commissioning, qualification and validation service includes:

  • Vigorous testing, validation and quality assurance
  • Facility start up and hyper care activities for single or multiple resources with a defined skill set delivering a loosely defined scope over varying contract time periods
  • Computer Systems Validation (CSV) programme delivery
  • Commissioning, Qualification and Validation (CQV) team support
  • Development of risk based approaches to testing

 

The scope of services we can provide in this regard are outlined below:

CSV Approach applies the concepts outlined in: CSV Approach & Planning CSV Testing & Software Teams
FDA Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach.

ASTM E2500 – 13 Standard Guide for Specification,

Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

International Council for Harmonisation (ICH)*

Framework

ISPE – GAMP 5 Guide: Compliant GxP
Computerized Systems

 

 

Integrating your CSV plan with your equipment validation approach

Reduced Testing – Time of testing and repeated tests

‘Know your process’ – Risk based testing approach defined by the critical quality attributes and parameters

Leveraging the testing into Sustaining Operations

– ICHQ10 Quality Systems

Provision of Factory Acceptance Testing (FAT) teams

Provision of site CSV teams with managed oversight and reporting

Provision of Automation, MES and QC Lab IT resources to support CQV

Execution of the full risk management lifecycle including the execution of the risk assessments driving actions

Project Life Cycle Management Solutions

Consultancy

Full Proficiency Planning Model to ensuring project success.

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Enterprise / System Integration

World leading Automation, Process Control and MES project implementation.

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Services

Managing and optimising your investment for long term success.

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Learning Solutions

Your global Life Science Training Partner.

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