Protocol Development and Execution of Installation and Operational Qualifications (IQ and OQ) which verify that the equipment has been installed properly and is capable of operating in accordance with the manufacturer’s specifications and requirements.- Execution of Equipment Qualification Studies which simulate actual operating ranges, or capabilities, and establishes consistency of operation using multiple tests.
- Execution of Temperature Distribution and Humidity Studies which demonstrate that temperature and/or humidity controlled equipment performs to specified parameters using temperature and/or humidity mapping strategies with Kaye Instruments metrology equipment. The Kaye application software can be configured to perform data collection such as minimum, maximum, average, lethality, etc., which provide the ability to cover your data reporting needs. All measurements results are documented and technically reviewed prior to final customer reporting and meet ANSI/NCSLZ540-1 requirements. All test equipment used is directly traceable to the National Institute of Standards Technology (NIST).
- Creation of Standard Operating Procedures (SOP’s) which instruct the personnel on how to operate the equipment.
- Annual Re-Validation which ensure continuous GMP compliance.
