Production, QHSES & Compliance
Computerised System Validation
+ de 50 establishments
Project
Framework contract for the validation of computerised systems in health care institution
- 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)
Challenges
- Quality : 5/5
- Cost : 2/5
- Deadlines : 3/5
- Security : 4/5
Expertise
- Regulatory (GAMP 5, 21 CFR part 11)
- Data integrity
- Validation
Prestations réalisées
- Evaluation de l’existant & état des lieux des documents disponibles
- Plan directeur de validation et analyse de risques intégrant « l’usage prévu » (configuration mise en place) et les infrastructures / périphériques / interfaces spécifiques vs documents fournisseur
- Protocole complémentaire et fiches de tests de QI / QO / QP intégrant les exigences d’intégrité des données et l’organisation en place au sein de l’établissement
- Support à l’exécution des tests complémentaires
- Rapports de QI-QO-QP et rapport final de validation
Insight
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