IT validation, 21 CFR 11 and Software Validation Resources
While there are many people in the industry that would claim that access databases are not designed to meet GxP security and audit trail requirements, there are some others that have found the way to meet those requirements by using some external tools. This article describes the methodology and documentation used to validate Access forms [...]
Paul Henderson on his article titled Time to Get Positive about Negative Testing, talks about how people in the QA arena are not putting too much importance or importance at all in the value added to projects and quality of Negative Testing. Henderson adds “For example, unusual combinations of data inputs, overflows from long running [...]
The Quality Assurance Journal just published their Speaker Abstracts of the Society of Quality Assurance 26th Annual Meeting, Cincinnati, Ohio, USA 25 – 30 April 2010. While going through it, I saw a couple of articles that should be interesting and of importance to the computer systems validation professional. The following list includes some of [...]
A field that is still new for some of us is the field of Electronic Health Records. We have seen how electronic health records are slowly becoming important and the norm. Back in January 2005 the Bush Administration called for the creation of a nationwide network of electronic health records (EHR) within 10 years. As you [...]
As part of the implementation of new information systems in the FDA regulated industry, we leverage some of the testing that has been performed by the software vendor. Most of the time, as part of the software vendor audit, auditors have access to the testing documentation used to support the SDLC of the application. One [...]
As Software QA professionals in the FDA industry, we are constantly asked to advice on how much time should be allocated for testing purposes. How much time we end up assigning to the generation, approval and execution of computer validation protocols to test our software is always part of a big debate. Randy Rice gives [...]
In this article, David Ade, a product manager at MasterControl Inc., describes the Advantages to Risk-Based Validation. He proposes the use of vendor provided documentation for Commercial off-the-shelf(COTS) systems to reduce the amount of testing that needs to be performed to support validation projects. As he explains, ”common attribute of successful and rapid risk-based validation is [...]
For those who did not know, or were not aware of it, the National Institute for Standards and Technology (NIST) published in 2002 the Risk Management Guide for Information Technology Systems-Recommendations of the National Institute of Standards and Technology which provide Software Quality Assurance Professionals with very important information that could be used when dealing [...]
We all know that the FDA is being increasing their focus on computer systems validation due to the importance and the emerging market of information systems that replace manual systems that are used to support GxP activities. Mr. Gregor in this article, goes over the key elements that every company with GxP Computer Systems should [...]
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