Computerised Quality Systems Validation

Commission computerised systems for use in biopharmaceuticals manufacturing facilities



Competency Area

Quality Assurance


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