Metrohm’s response to Analytical Instrument Qualification is contained within the Metrohm Compliance Services document, while the most detailed level of documentation offered for AIQ is the IQ/OQ.

Qualification demonstrates that equipment is what it is purported to be and does what it is supposed to do. Installation qualification (IQ), operational qualification (OQ), and performance ...

How has pharmaceutical manufacturing validation influenced analytical instrument qualification during the last 20 years and what are the emerging trends for the future? General guidelines regarding ...

Quality and reliability are essential in pharmaceutical manufacturing. To ensure compliance and high standards are consistently met, the Installation Qualification (IQ), Operational Qualification (OQ) ...

In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...

(click to enlarge)This is an example of a table that would be included in a qualification protocol in a prerequisites test section. An official copy of the protocol is printed and the tester fills in ...

Typical questions that arise include, why is it necessary to qualify analytical instruments in such environments? Why do titrando or OMNIS systems need such a service? Here, the safety of consumers is ...