LUNA™ IQ/OQ Protocol
LUNA™ IQ/OQ Protocol Product Description 1. This IQ/OQ protocol is used to verify: • The installation and operation of a newly purchased or a previously installed instrument.• Updates or upgrades that may affect the instrument’s performance.• The operation of the instrument that requires regular operation qualifications.• The requalification of a previously qualified instrument that has been reinstalled or moved to a new location. 2. This IQ/OQ protocol is required by: • Users who need to validate quality management systems such as GMP, GLP, GCP, or ISO standards.* Note: Logos Biosystems makes no representation or warranties of any kinds that this IQ/OQ protocol meets or will meet any mandatory requirements of any governmental organization or other entities in any country in the world. The customer acknowledges and agrees that the customer is responsible for meeting governmental regulations and certification requirements.*Note: The software of the LUNA-II™ does NOT meet 21 CFR Part 1