Simplify instrument document storage using digital formats
The digital laboratory records used for instrument inspection, maintenance, testing, and calibration provide a convenient document storage method consistent with electronic record keeping
Meet multiple regulatory guidance principles for instrument validation and maintenance
The standardized IQ/OQ/PM/WA/SA services performed by certified on-site service engineers comply with FDA 21 CFR and EudraLex Volume 4 guidelines for instrument validation and maintenance.
Whaleintelli only certifies the operational qualifications of instruments when executed by Whaleintelli certified engineers
Characteristic
Installation Qualification （IQ）
Verify and record that all necessary components required for the operation have been received and installed correctly according to the Whaleintelli installation plan.
Operate Confirm （OQ）
Test each system upstream and downstream, including mechanical, electrical, and optical components, to verify whether the operational functions comply with Whaleintelli product operating specifications.
Preventive maintenance （PM）
Every upstream and downstream system undergoes calibration, inspection, and lubrication - any potential issues will be proactively addressed. Our comprehensive multi-point inspection and testing ensure that each system complies with our product operating standards.
Compliance solution - ensuring the integrity and compliance of laboratory data.
Our complete set of validated compliance solutions for laboratories can drive you to quickly and confidently establish a compliant laboratory.
· First class upstream and downstream equipment system
· Industry leading AMR software - our safest software that achieves comprehensive compliance with FDA 21 CFR Part 11
· IQ/OQ/PM services save instrument documents in digital and compliant formats
· Software installation and verification service verifies and records whether the required components have been installed according to the operating specifications