Looking for ways to decrease computer-system validation time and cost?
In this article, David Ade, a product manager at MasterControl Inc., describes the Advantages to Risk-Based Validation
Risk Management Guide for Information Technology Systems
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
21 CFR 11 Pocket Guide… There is an App for that!
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 C-Electronic Signatures.
Here it comes… The FDA to conduct 21 CFR 11 Inspections
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 the impact... [Read more of this post]
IT internal audits
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 and data integrity. An underlying network must be... [Read more of this post]
Validating Access Databases for GxP applications
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 and reports generated to support GxP activities. Read More →
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