In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of the FDA’s regular inspections. 261 more words
Tags » Computer System Validation
ICH Q9 Quality Risk Management issued in 2009 laid out the basic principles for risk management to be utilized in all areas of the pharmaceutical industry including clinical trials but also manufacturing, computer system validation etc.. 199 more words
Asking why Computer System Validation (CSV) is important in FDA-regulated industries is like asking why an engine is important to a vehicle.
Before going on to get an understanding of this issue, let us understand that there is a difference between the ways in which the term “validation” is used in the general area of computers and that used in FDA-related circles. 367 more words
In Part II of ARITHMOS‘ article series on pharmacovigilance best practices, we address the need of project implementation and maintenance by introducing the Consortium initiative which helps companies significantly reduce costs while receiving expert advice from cross-functional teams. 384 more words
In this two-part blog, ARITHMOS takes an extract from its article series on migrating safety data and cases from legacy pharmacovigilance systems to Oracle Argus. ARITHMOS describes the process involved in data migration and validation principles and considerations during the production phase to ensure efficient and cost-effective pharmacovigilance practices. 386 more words
This week ARITHMOS has been focusing on Computer System Validation and the importance of implementing a proactive approach to system validation and maintenance. In this week’s blog post, we look at FDA warning letters, what they mean and how to avoid them by following the computer system validation life cycle. 531 more words
Current regulations expect that all users are appropriately trained and that must include being trained how to effectively perform UAT.
This course provides an understanding of the role of users in system validation and covers good documentation practice and the writing of UAT scripts. 222 more words