Computerized System Validation

Service Description

Topics covered: • Objectives and benefits of computerized system validation for your company • Applicable regulatory and normative requirements • The main validation phases / Computerized system lifecycle approach • Managing a validation project • Document management: deliverables and responsibilities • Requirements management • Risk management • Data integrity requirements applicable to computerized systems • Change and configuration management • Supplier activities • Maintaining the validated state By the end of this training, we hope your teams will be able to: • Understand the purpose and challenges of computerized system validation • Know and understand the objectives of the various validation steps for a computerized system • Use risk analyses to define and optimize the validation effort • Understand the concepts of lifecycle and maintaining the validated state.