Computer System Validation Training and solution
FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications confirm to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”
Topics covered on this training include:
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Risk & GAP Analysis by reviewing the current computer systems SOPs, Policies and the process.
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Identify non-compliant areas
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Corrective and preventive action plan including the preparation of Validation Master Plan, System Requirements and Design Qualification, Qualification Plan, IQ, OQ, PQ and Qualification Report.
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Provide Best Practices Training
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Implementation of SOPs to handle Incident Report , Periodic System Reviews ,Backup and Recovery and Continuity Planning
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Complete Project Management