규정·검증

IQ OQ PQ are the three qualification stages required to validate analytical instruments in GxP regulated environments.

FDA 21 CFR Part 11 sets the requirements for electronic records and signatures in regulated laboratory environments.

Audit trails and electronic signatures are foundational data integrity controls required by FDA and global regulatory agencies.

Quality by Design and Process Analytical Technology are FDA frameworks that use real-time measurement to build quality into manufacturing processes.

NIST-traceable standards provide a documented chain of measurement accuracy linking laboratory instruments to national reference values.