DQ supports the functional & quality specifications designed into PyroButton. Documentary proof of DQ compliance includes:
- IQ-OQ-PQ protocols
- 21 CFR Part 11 Verification Summary,
- Measurement Performance Design Summary, and
- NIST Traceable Calibration Summary
IQ (Installation Qualification) - IQ supports the requirement for proper installation and acceptance qualification for PyroButton. Documentary proof of IQ compliance includes:
- Receipt & acceptance checklist,
- Physical & electrical compliance checklist,
- Environmental compliance checklist,
- Training compliance checklist, and
- Final IQ Summary
OQ (Operational Qualification) - OQ supports the specification compliant functioning of the system. Documentary proof of OQ compliance includes:
- 21 CFR Part 11 operational specification checklist,
- Software operational specification checklist,
- Instrument interface operational specification checklist,
- Instrument operational specification checklist, and
- Final OQ Summary
PQ (Performance Qualification) - PQ supports quality evaluation & quality compliance management of the system. PQ compliance models include:
- 21 CFR Part 11 compliance models,
- Simulation models for data-acquisition optimization, and
- SQC models for measurement qualification review.
|
Vissza
