Preparation/Execution/Review of Validation Plans (VP), System Impact Assessments (SIA), Requirements Specifications (RS), Design Specifications (DS), Functional Requirements Specification (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), and Validation Summary Report (VSR) for equipment, analytical/laboratory equipment, critical systems and utilities, Process Performance Qualification (PPQ) for the product manufacturing process and Release Authorization to release validated items into use.
Evaluate changes to any validated systems, equipment, process, or procedure in terms of their effect on the state of validation through the change control program and in Compliance with the Quality System, using tools like Risk Assessment, FMEA, and others.
Develop/Review SOPs that meet all applicable regulatory requirements.
Works with appropriate parties to provide corrective and preventive actions based on sound engineering analysis.
Develop/review computer validation strategies including the development and review of computer validation documents such as user requirements specifications, validation plans, function, and design specifications, testing protocols, risk assessments, and validation summary reports, under FDA 21CFR11.
Reviews and ensures all process, material, and procedural changes are appropriate and in compliance with regulatory requirements, ISO, and quality policies of the company.
Reviews and ensures all qualification and validation documents are compliant with all applicable regulatory requirements and quality policies of the company.
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