Analytical Method Validation
Verify analytical methods used to ensure accuracy, validity and reliability
Type
Domain
Competency Area
Quality Assurance and Quality Control Management
Levels
Apply procedures in data collection to support analytical method validation
Identify data collection methodologies to be applied, based on critical validation characteristics to be studied
Follow work plans and schedules to complete collection work on time
Collect data on critical validation characteristics, according to SOPs
Store data in appropriate formats
Clean up data to remove incomplete, duplicated and/or incorrect data
Support identification of process deviations
Submit data for evaluation
Perform critical method validation characteristics studies
Identify critical method validation characteristics to be studied, based on specific analytical methods
Prepare lead-time, resources and schedules, based on specific analytical methods
Perform critical method
validation characteristics studies, according to Standard Operating Procedures (SOPs)
Analyse method validation results
Document method validation results
Establish and oversee analytical method validation processes and activities
Develop analytical method validation plans
Articulate objectives, and key indicators, of analytical method validation
Specify quality control test requirements to be validated
Evaluate impact of QC test process changes on analytical methods required
Develop internal analytical method validation Standard Operating Procedures (SOPs) and documentation
Review method validation results
Evaluate validation reports to identify areas for improvement
Recommend changes to QC testing procedures and analysis
Lead analytical method validations to ensure consistency of processes
Advise on critical process steps requiring QC testing and analysis
Collaborate with key stakeholders across functions to approve validation of analytical methodologies
Drive analytical method validation improvements