is being presented by Terri Mead, President, of Solutions2Projects, LLC and airs on Wednesday, May 25th, 2011. For more details or to register, please visit our site at www.fxconferences.com
In the past, vendor audits were standard practice prior to the purchase of, or as part of validating, an IT system. As resources have gotten tighter and life sciences companies perhaps perceived less of a threat from the FDA on computer validation, many companies have moved away from performing vendor audits.
These days, FDA is scrutinizing IT systems, and has not overlooked the tendency with many companies to try and justify their way out of conducting vendor audits. This is true for both the outsourcing of processes to CROs and the implementation of IT systems on-site. With FDA’s focus on computer systems as part of PAIs and other inspections, ignoring vendor audits is a risk you can’t afford to take.
This audio conference presentation takes attendees through the elements of a vendor audit for both the purchase of software for a validated system, and for outsourcing of services that include IT systems such as clinical trial management.
