"Bridge The Gap Between Business, Development and Validation"

The need to test computerised systems is well documented in certain regulatory compliance environments, (e.g. FDA's General Practices for Computerised Systems in GxP). However, the know how to test computerised systems is not so well defined.

As a Quality Assurance and Technical Test Consultancy, we have the software engineering skills to provide you with the know-how to test computerised systems. Not only that - we also posses the vital experience of testing within regulated environments. You really do benefit from the best of both worlds.

The operations and validation of computerised systems are essential for the enhancement of product safety and ensures the health of consumers. Our people have vast experience of clinical trials and drug supply management. Having worked for some of the worlds leading pharmaceutical companies, we have created bespoke development, QA and test strategies which have:

  • Decreased the occurrence of latent issues.
  • Increased the volume of issues captured before operational use.
  • Increased the volume of technical issues.
  • Minimised the time spent on user testing.
  • Enhanced the computerised system usability.
  • Increased reliability.
  • Increased business visibility on computerised systems.
  • Reduced remedial action (through robust requirements reviews).
  • Reduced user risk.
  • Made remedial action easier.
  • Increased productivity through more efficient processes and testing.
  • Increased productivity through greater throughput of projects from more efficient QA & test processes.
  • Provided full traceability of decisions and work performed.
  • Reduced costs by reducing the volume of issues found at the end of the project where it costs more to fix.
  • Received praise from an MHRA auditor.
  • Ensured full compliance to FDA and GXP.

Please contact us today to see how we can help you Bridge the Gap between Business, Computerised Systems and Validation.

EQE: Knowing what to test, how to test and when to test "IT".