Market Consultation. Computerized Quality Management System meeting Good Manufacturing Practice requirements AI
Expired
Market Consultation
72260000 - Software-related services
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Subject of Procurement
What is being purchased: A computerized Quality Management System (eQMS) compliant with Good Manufacturing Practice (GMP) requirements. The subject of procurement is Services (although a system is described, the tables specify implementation and maintenance works).
Main technical requirements, features:
The system must comply with GxP requirements, including GMP (especially EU GMP Annex 11 and/or FDA 21 CFR Part 11).
Computerized System Validation (CSV): Full CSV is mandatory,…