Column: Focus on Quality

Dec 01, 2017
Spectroscopy
Good practice (GxP) regulations require an instrument maintenance and use log. Have spectroscopy laboratories and software suppliers emerged from the Middle Ages yet?
Nov 01, 2017
Spectroscopy
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?
Sep 01, 2017
Spectroscopy
The new version of United States Pharmacopeia general chapter <1058> “Analytical Instrument Qualification” became effective August 1, 2017. What does this mean for you?
Apr 01, 2017
Spectroscopy
Data integrity requires a multilayered approach that runs throughout a regulated organization. Here we discuss the laboratory level, and discuss the impact of the data governance scheme as it cascades down to the processes and systems at the bench. The main focus here is on data ownership and data stewards.
Feb 01, 2017
Spectroscopy
Data governance to ensure GXP data integrity requires a multilayered approach that runs throughout a regulated organization. Here in Part I of this two-part article, we consider data integrity from the corporate level.
Nov 01, 2016
Spectroscopy
Raw data is a term that is often used in both good manufacturing practice and good laboratory practice, but there is often confusion surrounding the term. What exactly does raw data mean and what records are within the scope of the term?
Sep 01, 2016
Spectroscopy
Data integrity is the currently hottest topic in regulated good practice (GxP) laboratories. Here’s what you need to know about the latest guidelines, issued by the FDA in April 2016.
Apr 01, 2016
Spectroscopy
Thinking about data integrity in four layers makes it easier to fully understand the overall scope and complexity of this topic. It also facilitates proper implementation of data integrity programs to ensure effective regulatory compliance.
Dec 01, 2015
Spectroscopy
The United States Food and Drug Administration has issued a draft guidance on the development and submission of near infrared (NIR) analytical procedures. Here, we explain and critique key aspects of the document.
Nov 01, 2015
Spectroscopy
The UK regulatory body issued a guidance that requires the establishment of a data governance system, part of which is data integrity training. Easy to say, but how do you do it?
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