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© 2022 MJH Life Sciences and Spectroscopy Online. All rights reserved.
© 2022 MJH Life Sciences™ and Spectroscopy Online. All rights reserved.
September 01, 2019
Analysis of FDA Form 483 observations and warning letters for infrared spectrometers reveals a range of data integrity problems and a lack of laboratory procedures for the technique. Is your laboratory in the same situation?
April 01, 2019
In the current data-integrity–centric world, is outsourcing your spectroscopy work a good idea? To answer this question, one must consider several factors.
December 01, 2018
Regulatory definitions can be confusing at all levels. In this article clear definitions of raw data are clarified and compared. A discussion of static and dynamic data is given along with a detailed summary of the impact of these terms on raw data.
November 01, 2018
The password paradox states that simple passwords are simple to remember but easy to break, but complex passwords that are difficult to hack are also difficult to remember. Is there a better way?
September 01, 2018
Does a one size fits all data life cycle meet laboratory requirements for data integrity? No! The reason is that there are many different types of analytical procedures and this requires a flexible analytical data life cycle.
April 01, 2018
We live in a new world where users must specify what they want their analytical instruments to do. This discussion will help you figure out how to make sure you get what you need.
December 01, 2017
Good practice (GxP) regulations require an instrument maintenance and use log. Have spectroscopy laboratories and software suppliers emerged from the Middle Ages yet?
November 01, 2017
It has been 20 years since 21 CFR 11 came into effect. And with increased emphasis on data integrity, an audit trail is essential for spectroscopy software. Why then do many audit trails fail to meet regulatory requirements?
September 01, 2017
The new version of United States Pharmacopeia general chapter “Analytical Instrument Qualification” became effective August 1, 2017. What does this mean for you?
April 01, 2017
Data integrity requires a multilayered approach that runs throughout a regulated organization. Here we discuss the laboratory level.