Tags » Computer System Validation

Webinar On Risk Management Principles

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

Life Science

GxP in Computer System Validation

GxP in Computer System Validation.

GxP (Good X Practice, where according to FDA compliance; X can mean Clinical, Laboratory, Manufacturing, Pharmaceutical, etc., and used according to the situation in which they occur) in Computer System Validation occupies a position of primacy in the field of technology because of various reasons. 281 more words

MEDICAL DEVICE

Live webinar on FDA’s 21 CFR Part 11 Add-on Inspections

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

Life Science

Webinar On Risk Management Principles

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

Life Science

Why is Computer System Validation Important in FDA Regulated Industries?

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

Fda Compliance