Analytical Method Validation

Verify analytical methods used to ensure accuracy, validity and reliability



Competency Area

Quality Assurance and Quality Control Management


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