Computer System Validation

A CRO company requires the services of an expertise freelance for 2 projects: 1. the validation of its IT system in order to proceed to a paperless mode of operation and 2. an overview assessment of the validation of a custom build database. Responsibilities: A. Development of a full package validation documentation for the validation of our company’s IT system in accordance with 21 Code of Federal Regulations (CFR) Part 11 , GAMP 5 and EMEA, EudraLex —Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use: Annex 11—Computerized Systems i.e. a. Validation plan b. Risk Assessment c. User/functional requirements (in lieu with our company) d. Requirements Traceability Matrix e. Design Specifications / Qualification (in lieu with our IT and/or database vendor) f. Disaster Recovery Plan (in lieu with our IT and/or database vendor) g. Review of Change Control document h. Installation plan and qualification i. Operational and Performance Qualification j. Test Plan k. Validation Report l. Assistance in the systems SOP development Support will be required for the system’s project phase. B. Assessment of the validation package developed by our company regarding custom build database Operational phase and system retirement phase (if applicable) shall be addressed in the SOPs but will be handle by our company.