Computerised Quality Systems Validation
Commission computerised systems for use in biopharmaceuticals manufacturing facilities
Type
Functional
Competency Area
Quality Assurance
Levels
Perform validation tests as per Sttistical Quality Validation Procedures
Identify Destructive and non-destructive testing procedures for various processes
Identify the right programmes for statistical validation
Carry out validation procedures and controls to ensure the fidelity of the data
Perform suitability testing for manufacturing processes
Conduct failure testing and risk assessments
Identify the immediate impact of computerised system programming changes on manufacturing processes
Develop validation procedures for computerised systems and evaluate validation results
Plan quality validation procedures in accordance withthe adopted manfacturing quality standards (ISO/Lean etc)
Map out tests and procedures required and ensure that all QA procedures are compliant with organisation's commitments
Evaluate impact analyses and provide feedback regulraly
Evaluate fesibility to lead indictaor-based risk/quality assessments to reduce cost of poor quality
Recommend suitable computerised systems for online testing of plant operations
Ensure quality of integrated systems across the manufacturing process chain
Identify the right points for testing
Articulate a quality management philosophy across all functions and activities
Determine applicable regulations for compliance for the organisation’s manufacturing processes
Ensure that all emission controls are well within relations
Build a culture of quality consciousness among all levels and incentives right behaviours at all levels