FDA & GMP Compliance
Validation
POA provides validation testing and documentation to ensure systems meet FDA, GMP, and international requirements with documented proof of performance.
Confidence through compliance
Our validation approach leverages the symbiotic relationship between our integration, instrumentation, production, and validation departments to deliver complete and thoughrough documentation and support throughout the system's lifecycle.
Quality Management System Development
We develop and implement Quality Management Systems tailored to your operations—including Validation Master Plans, Risk Assessments, and Standard Operating Procedures.
Protocol Authoring & Execution
POA authors functional specifications, acceptance testing, and IQ/OQ/PQ protocols—executes the testing, provides internal quality review anddescrepancy resolution, and support until the system is released for production.
Acceptance Testing
Our integration and validation team author and execute factory acceptance tests and site acceptance tests proving your system performs as designed before going live.
Temperature & Humidity Mapping
We execute comprehensive CTE mapping for warehouses, cold rooms, refrigerators, freezers, incubators, and stability chambers with statistical analysis.
Commissioning & Turnover
We install and startup automated systems, maintain change control and configuration files, calibrate instruments, tune process loops, provide operator training, and ongoing support.
Audit-Ready Documentation
From requirements, to design, to installation, calibration, and commissioning, POA produces complete validation documents that meet FDA, GMP, and international expectations on the first review.
Unified expertise that endures
Our coordinated approach connects every discipline into a single quality framework that maintains long-term system performance.
Validation workflow
Every validation project follows a defined quality process under our ISO 9001:2015 accredated eQMS. Each phase is managed by GMP trained specialists who ensure traceability and consistency.
