21 CFR part 11 and Computer Systems Validation Resources
IT Infrastructure is one of the most important aspects in the qualification of GxP applications.The following articles/presentations provide different points of views on how to approach the qualification of IT infrastructure that will be used to support GxP applications: IT Infrastructure Qualification and System Validation: IT Vendor Perspectives- by Siddhartha Gigoo. An Approach to IT Infrastructure [...]
According to this article 74% of doctors want computer based means to share the data with other doctors. However, only 17% of doctors share information at this point. This means that this market is still in its infancy and that a lot of new systems will be implemented in the next few years. The computer [...]
As many predicted, the FDA has announced that they will be conducting inspections to evaluate industry’s compliance and understanding of Part 11 after the publication of the ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance)’.(See FDA Regulations). It will be interesting to see the results of the evaluation as to what was [...]
From the article Internal Audits for Pharma and Biotech , the following is the IT section where the author (MICHAEL J. GREGOR, PRESIDENT, COMPLIANCE GURUS INC.) details some of the rational for auditing the IT department and some of the questions and or documents that should be in place. “The IT department is responsible for data security [...]
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 [...]
Here is a list of “100 of the best – or at least most popular – Software Testing Blogs in the world” as rated by the TestingMinded Blog. This list provides a very good start for people interested in the Software testing arena. The order of the blogs is supported by data provided by the [...]
In this presentation, Joga Gobburu talks about the need of good software practices, and FDA regulatory guidances. Very interesting presentation where the presenter goes over the following good software practices: Installation Restricted privileges Qualify Physical Functional Maintenance Revision controls (audit trials) Updates (vendor)
The Quality Assurance Journal