IT validation, 21 CFR 11 and Software Validation Resources
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 [...]
Yes, there is an app for that . BKP Technologies, Inc. developed and released an iPod Touch, iPhone application that provides instant access to the 21 CFR 11 regulation. Using the Final Rule (Source: 62 FR 13464, Mar 20, 1997), the application presents an Index that covers Subpart A-General Provisions, Subpart B-Electronic Records and Subpart [...]
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 [...]
A Comprehensive Information System Validation Model- Kyungsub Steve Choi This paper attempts to to integrate Food and Drug Administration(FDA) computerized systems validation regulations,Securities & Exchange Commission(SEC) Sarbanes-Oxley Act of 200 and other significant regulations, and lastly, People Capability Maturity Model (P-CMM) into one comprehensive information system validation model. After providing general information on the validation [...]
Well, today is your lucky day. Syberworks will have a webinar that will include the identification of Hazards, Ranking of Risk and identifying Mitigations for the purpose of concentrating the validation of a computer system to determine if it is fit for its intended use. A Risk-Based Approach to FDA Computer Systems Validation Date: Tuesday, [...]
The Software Quality Engineering has just issued this Press Release announcing two annual spring conferences for software managers, developers, project managers, business analysts and test and QA professionals – the Better Software Conference and Agile Development Practices/West. Both conferences will be held concurrently, June 6-11, 2010, at Caesars Palace, Las Vegas, NV.
As indicated in the Guidance for Industry-Computerized Systems used in Clinical Investigations (May 2007), Audit Trails should be in place to “keep track of all the changes made to information in the electronic records that document activities related to the conduct of the trial”. In general, Audit Trails are necessary to verify the quality and [...]
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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