Miscellaneous documents, including: Key Terms And Concepts Of Computer Validation, Options For A Computerised System Validation Course, Robert D McDowall Curriculum Vitae, Short Course Quotes, 21 CFR 11 Services, Analytical Methods Validation and Chromatography Data Systems Services.
There are a number of terms and concepts that we need to get right before we start the detailed journey into validation of your software in the following articles in this series.
A list of possible topics to be covered on a computerised system validation course.
The Curriculum Vitae of Robert D McDowall.
21 CFR 11 Services offered by McDowall Consulting.
Bob McDowall has been involved in writing on analytical methods validation for many years, he has written several key papers on the subject. Find out more here...
Bob McDowall has used chromatography data systems in various types over his whole career (disc integrators to client server data systems). As editor of the Questions of Quality column in LC-GC magazine, he has written a five part series on the acquisition, validation and retirement of chromatography data systems. These articles are available for download here.
This Library section covers the increasingly important area of regulatory compliance in the IT Departments of the pharmaceutical and other regulated industries.
In this library section, find articles from my column called Focus on Quality from Spectroscopy magazine dealing with the validation of spectrometry software.