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Lumenia specialises in regulatory software testing and computer systems validation (CSV) services, helping clients to ensure that key business systems are fully functional and in compliance with applicable regulations. Our consultants all have GMP/FDA environment experience preparing validation lifecycle documentation, conducting vendor audits, performing systems assessments and preparing protocols.

Our risk-based approach ensures that your systems comply with all regulatory constraints in an efficient and cost-effective manner.

Lumenia have successfully led the validation activities on our ERP SAP system, QUMAS Document Management system, as well as the qualification of our IT Infrastructure. Patsy Carney, Managing Director, Eirgen
Our solution

How we add value

  • Our methodology saves you time and money whilst ensuring that the system fully complies with regulations
  • Our approach ensures compliance and the ability to withstand any audit
  • We help ensure the documentation effort is minimised
  • Our risk-based approach identifies the critical functions and ensures the number of validation use cases is minimised
  • Our approach is recyclable and the framework can be applied to any systems

Tangible deliverables

  • Validation master plan
  • Vendor audit preparation and execution
  • User requirements documentation
  • CSV protocol generation and execution (i.e. IQ/OQ/PQ)
  • CSV training for management and engineers
  • System compliance support

The b​​​​enefits 

  • Our proven validation approach certifies computer systems in an efficient and secure manner
  • Clients are able to put solutions to work more quickly and therefore realise benefits more quickly
  • Application of best practice methods according to GAMP® 5 and up-to-date industry standards

 

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