• Document: Conceptos Básicos y Marco Regional para la Validación de Software
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Conceptos Básicos y Marco Regional para la Validación de Software 1 Conceptos Básicos y Marco Regional para la Validación de Software 2 1 World’s changes The Pharmaceutical Industry has adapted its business model in response to growing industry constraints and the decline of the primary-care focused blockbuster therapy. Principal Key Success Factors of success in this “scenario” are:  Maintaining Quality  Optimising Process  Cost Management  Reducing Time to Market  Optimising Supply Chain Latino America Consultores, with its experience, is one of the most Qualified Partners in South America to achieve that goal, according to cGMP requirements, with a special focus on Pharmaceutical Business Evolution. Conceptos Básicos y Marco Regional para la Validación de Software 3 International Support  Support in R&D  Technology Transfer  Business Process Re-engineering  Feasibility Studies Momentum Life Science™  Qualification, Validation & Management  Engineering, Design & Construction Support  Regulatory Affairs  Business Development & Alliance  Quality in Outsourcing & Auditing  IT in Compliance  Training Conceptos Básicos y Marco Regional para la Validación de Software 4 2 Product Knowledge Engineering  Project: URS, Feasibility, Preliminary Budgeting, Conceptual Design, Basic Design, Detailed Design, Design Qualification  Verification: Equipment & Plant Qualification Support, Utilities Qualification Support, Analytical Methods & Equipment Qualification, Information & Data Management System Validation Product & Process Support  Supports for Formulation, Pilot Phases, Scale Up and Industrialization  Process Qualification  Technology Transfer Support Regulatory Affairs & Compliance  International Regulatory Support  Supports in Preparation Dossiers  Supports in Preparation of Technical File for Medical Devices  Preparation and Implementation of Variation Procedures Compliance, Innovation & Data Management ERP, LIMS, DCS, SCADA, WMS, EDMS have to be in Compliance.  Feasibility Study & Software & Supplier Selection  Solution Providing & System Integration Support  Computer System Validation (GAMP 5.0), 21 CFR 11 Compliance  GxP Risk Assessment & Remediation Plan Management  Support for IT Infrastructure Management & Enhancement, Networks Qualification  Legacy System Assessment & Full Plant Remediation Support Conceptos Básicos y Marco Regional para la Validación de Software 5 Computer System Validation Basic Principles, International References Conceptos Básicos y Marco Regional para la Validación de Software 6 3 Validación: DEFINICIÓN 1. “Validación es la recopilación y documentación de evidencias suficientes para dar certeza razonable, dado el estado de la ciencia, que el proceso en consideración opera, y / u operará, según lo esperado” (B. Loftus, Process Validation - The Regulatory View, Proceedings of the Proprietary Association, 1979 Manufacturing Controls Seminary) 2. “Validación es establecer evidencia documentada la cual proporciona un alto grado de certeza que un proceso especifico producirá consistentemente un producto que cumpla las especificaciones y características de calidad predeterminadas” (FDA Guideline on General Principles of Validation, 1987) 3. La validación es una estrategia definida de prácticas y procedimientos inter-relacionados que en combinación con métodos de producción de rutina y técnicas de control de calidad ofrece garantía documentada de que un sistema está funcionando como se pretende de manera repetitiva y / o que un producto cumple con las especificaciones predeterminadas. (PDA TM#1 revised, Draft 13, Glossary)

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