COMPUTER SYSTEM VALIDATION AND DATA INTEGRITY

This two (2) days course is designed to provide an overview of the various aspects of computer systems validation and related validation documents and to provide the basis for compliance and implementation. The course addresses the rules, tools, and techniques to develop and implement a validation program or to validate a specific system. The course provides the principles for computer validation and offers a framework and the methodologies to conduct validation projects. The emphasis is on the most recent rules and techniques focusing in the relevant regulations, the system life cycle including requirements, design/build, testing, qualifications and maintenance, 21 CFR Part 11 Electronic Records and Electronic Signatures and the journey this regulation has taken, vendor audit, acquired and developed systems, retrospective validation, validation master plan, the validation project risk assessment and management, SOPs, requirements documentation, the traceability matrix, and related FDA Guidance documents.

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