21st Century Computerised System Compliance

EmpowermentQE provide innovative and cost effective Computerised System Validation and Quality Assurance services to the regulated industry. We have vast experience of Computerised System GXP requirements within Europe and the US, such as: 21 CFR part 11 and Annex 11.
"Our software engineering background meets the demands of 21st Century Computerised System Compliance from a slightly different perspective: increasing efficiency, enhancing knowledge and lowering costs." Barry McManus, EmpowermentQE

EmpowermentQE Computerized Systems QA Consultancy

Some of the things that we do

  • Provide unique software engineering perspectives to Validation.
  • Robust COTS selection, implementation and Validation.
  • Establish a scalable approach to achieve and maintain CS Validation via a Quality Lifecycle.
  • Perform assessments and audits of 3rd Party CS Suppliers.
  • Provide techniques for process improvement of Computerized System Lifecycles.
  • Provide technical Validation consultants and CS Compliance as a Service.
  • Perform highly skilled and niche technical verification activities.
  • Provide practical & effective implementation of GAMP5 guidance - justifying effort based on risk.
  • Continuously leverage the latest thoughts from the wider software engineering community.
  • Provide training on the entire SDLC processes - understand the technical and people risks associated with building a CS.

Benefits

  • Minimise the time spent on validation testing.
  • Decrease the risk of latent issues.
  • Increased the volume of issues captured before operational use.
  • Increase reliability.
  • Reduce the time it takes to implement changes during operational use.
  • Increased productivity through greater throughput of projects from more efficient QA & verification.
  • Ensure full traceability of decisions and work performed.
  • Cut costs by reducing the volume of issues found at the end of the project where it costs more to fix.
  • Full knowledge retention by your organisation.
  • Reduce scope of awkward inpsection questions - reduce inspection time on Computerised Systems.
  • Enable right first time validation.

Find Out More About:

Computerised Systems Compliance as a Service.

Cross Pollination of wider software engineering practices with regulatory CS needs.

Bridge the Gap between Computerised Systems and Validation.

Really useful links section: information from SQL to Annex 11.

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Contact us for quick advice.

CS ValidationFDA 21 CFR Pt11Total Software Quality Management
Orange Guide Annex 113rd Party AuditsPIC/SSoftware Cross Pollination
Risk AssessmentsCloud Test StrategiesIndependent Project Management
a very professional, knowledgeable and structured approach... with a determination for success. Pharmaceutical Software Manager.