Computer System Validation
1 month ago
Perform and document validation activities for Empower software to ensure compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, EU GMP Annex 11). Develop, execute, and review validation protocols (IQ, OQ, PQ) for Empower installations and upgrades. Create and maintain validation master plans, validation summary reports, and validation traceability matrices.
Configure and customize Empower software according to user requirements and laboratory workflows. Set up user roles, permissions, and access controls within Empower. Assist in the integration of Empower with other laboratory systems (e.g., LIMS, ERP).
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