Computerised Systems Validation
Commission computerised systems for use in manufacturing facilities
Type
Domain
Competency Area
Quality Management
Levels
Perform validation tests for computerised systems according to established procedures
Schedule validation tests for computerised systems
Carry out validation procedures and controls for computerised systems in accordance with GAMPs regulations
Conduct impact analyses of computerised systems on quality and safety
Perform suitability testing for computerised systems
Conduct risk assessments of computerised systems
Identify the immediate impact of computerised system programming changes on manufacturing processes
Conduct assessment of computerised systems for compliance with GAMPs
Report results from computerised system validation tests
Implement improvements to current computerised systems and processes
Develop validation procedures for computerised systems and evaluate validation results
Plan computerised systems validation procedures in accordance with regulations and principles of Good Automated Manufacturing Procedures (GAMPs)
Map out tests and procedures required to validate computerised systems
Evaluate impact analyses and determine the overall effect of computerised systems on quality and safety
Evaluate potential risks associated with implementing computerised systems
Assess the impact of changes in computerised systems on production efficiency or quality
Recommend suitable computerised systems for manufacturing operations
Evaluate the compliance of computerised systems with GAMPs and regulatory guidelines
Evaluate results from computerised systems validation testing and identify gaps that affect manufacturing operations
Formulate validation strategies to ensure quality of integrated systems across the manufacturing process chain
Formulate strategies to validate computerised systems
Establish appropriate types and sequence of tests that can be employed to validate computerised systems
Articulate quality requirements and validation parameters for computerised systems
Oversee computerised systems validation procedures and controls in accordance with regulations and principles of Good Automated Manufacturing Procedures (GAMPs)
Anticipate the impact of changes in computerised systems to overall manufacturing operations
Determine applicable regulations for compliance for the organisation’s computerised systems
Evaluate methods to mitigate potential risks of computerised systems that impact manufacturing operations
Evaluate the suitability of improvements made to the organisation’s computerised systems and processes