Planning, execution, review, and troubleshooting for packaging and distribution testing.
ISTA and ASTM D4169 planning, transport simulation, performance testing, and failure investigation.
ISO 11607 strategy, validation planning, sterile barrier considerations, and technical documentation support.
IQ/OQ/PQ support, validation execution, acceptance criteria, inspection planning, and technical reporting.
Independent review of protocols, test methods, sample plans, acceptance criteria, and execution requirements.
Review and development of clear engineering reports, deviation documentation, conclusions, and recommendations.
Root cause analysis and corrective action support for product damage, package failures, or test nonconformities.