With instrument validation an integral part of many analytical procedures and protocols, it’s good to know that LAT can help you with your IQ/OQ and CFR21 requirements.

IQ/OQ

There are four main areas that need to be addressed when considering the validation of spectrophotometers:

DQ (Design Qualification) - the suitability of the instrument for the required task

IQ (Installation Qualification)-showing that the instrument complies with the manufacturer’s specification on installation

PQ (Performance Qualification)-showing that the instrument complies with established standards and practices

OQ (Operational Qualification)-providing documented evidence for continued operability and data integrity.

Engineers from LAT are fully qualified to provide IQ and OQ support. Instrument performance can be verified to manufacturers’ default thresholds and all servicing and validations are backed up by documentary evidence, highlighting the next time key parameters should be independently checked.

CFR21 Part 11

Another important area that LAT can help with is the FDA CFR 21 Part 11 requirements. These include security and data audit tracking, appropriate operator access levels, details of operator logins and logouts, and when each test is created, changed, deleted or aborted. Audit trails must provide an accurate history of data.