Defining And Managing User Requirements For Computer System Validation 2013

Key Topics

• Validation Plan: Defining the objectives of the Validation and the activities, procedures and responsibilities for accomplishing the objectives of the Validation
• User requirements Specification (URS): Defining clearly and precisely what the User wants the system to do and states any constraints (e.g. regulatory) under which the system must operate
• Project plan: Detailing the tasks and time line for the project
• Configuration Management, Change Control, and System Requirements
• Documentation: Justifying Selection of System including Supplier Audit Report, Outlining the reasons for choosing the system including the results of auditing the supplier`s quality management system

Who should Attend

• Persons subject to Quality System regulation
• Quality Assurance
• Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself
• Persons responsible for the design, development, or production of software
• FDA Compliance Officers
• FDA Investigators
• FDA Scientific Reviewers