QHSES & Compliance Computerised System Validation

+ 50 establishments


Framework contract for the validation of computerised systems in health care institutions

  • System inventory and drafting of the Validation Master Plan
  • Validation of two priority systems (REDCap and Safety Easy)
  • Integration of data integrity requirements (ALCOA)
  • Possible support for the compliance of the Quality Management System (QMS)
  • Remediation plan for systems integrated into the VMP and to be validated in accordance with regulatory requirements and reference guides (e.g.: GAMP 5)

Services provided

  • Assessment of the existing situation & inventory of available documents
  • Validation master plan and risk analysis integrating “intended use” (implemented configuration) and specific infrastructures/peripherals/interfaces vs. supplier documents
  • Supplementary protocol and IQ/OQ/PQ test sheets incorporating data integrity requirements and the organisation in place within the establishment
  • Support for the performance of additional tests
  • IQ-OQ-PQ reports and final validation report


  • Quality : 5/5
  • Cost : 2/5
  • Deadlines : 3/5
  • Security : 4/5



Regulatory (GAMP 5, 21 CFR part 11)

Data integrity


QHSES & Compliance

Fabrication shop risk assessment


Julia Moynier

QHSES & Compliance

Fabrication shop risk assessment


Julia Moynier