IT validation, 21 CFR 11 and Software 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 [...]
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 [...]
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 [...]
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