+ 50 establishments
Project
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
Challenges
- Quality : 5/5
- Cost : 2/5
- Deadlines : 3/5
- Security : 4/5
