is being presented by Terri Mead, President, of Solutions2Projects, LLC and airs on Thursday, September 22nd, 2011. For more details, or to register please visit our site at www.fxconferences.com
Computer validation isn’t about checking the boxes. It’s about satisfying compliance requirements and meeting business objectives in a productive and useful fashion. Far too often validation resources do not take into consideration why deliverables are generated, and simply say they must be done. Computer validation should not be executed with a cookie-cutter approach, and the thought process and justification should be documented as part of the validation effort.
Computer validation makes sense from a business perspective in that it gives you documented evidence that your computer system is installed, operates and performs per your business requirements. It also gives your organization a control framework and baseline for change management. Approaching computer validation as a value-add to the business to decrease overall costs, rather than just an exercise to ‘check the box’ in a one-size-fits-all validation approach, can satisfy both compliance and corporate objectives.
This audio conference presentation looks at general computer validation approaches in a risk-based world, covering standard procedures that should be in place to support validated systems, and discussing standard computer validation deliverables. Our speaker also reviews when and why deliverables should be generated, where to document when deliverables aren’t generated, and provides real-life examples of computer validation deliverables.
Showing posts with label Terri Mead. Show all posts
Showing posts with label Terri Mead. Show all posts
Friday, August 26, 2011
Monday, May 9, 2011
Conducting Vendor Audits from an IT Perspective
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.
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.
Thursday, March 17, 2011
Software Selection for Critical, High-Risk and Regulated Systems
is being presented by Terri Mead, President, of Solutions2Projects, LLC and airs on Wednesday, April 13th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Software vendors hate to deal with knowledgeable system selection teams. It makes their job of selling more difficult and creates more work for them. But that’s their problem. Your problem is identifying the best software solution to meet your company’s business needs, and ensuring a successful system implementation. How do you do this? By having a defined selection process whereby you understand and define what your company needs before selecting the software, have the vendors demonstrate their ability to fulfill your company’s needs in terms of functionality and service, and define the implementation project in detail before signing any agreements.
This audio conference presentation reviews the essential steps for system selection, as well as the additional steps required for critical and high-risk systems, or those that must be compliant with various regulations.
At the end of the project, your company and users have to live with the system. Learn how to make sure your company gets what it needs, and not just what the vendor wants to sell.
Software vendors hate to deal with knowledgeable system selection teams. It makes their job of selling more difficult and creates more work for them. But that’s their problem. Your problem is identifying the best software solution to meet your company’s business needs, and ensuring a successful system implementation. How do you do this? By having a defined selection process whereby you understand and define what your company needs before selecting the software, have the vendors demonstrate their ability to fulfill your company’s needs in terms of functionality and service, and define the implementation project in detail before signing any agreements.
This audio conference presentation reviews the essential steps for system selection, as well as the additional steps required for critical and high-risk systems, or those that must be compliant with various regulations.
At the end of the project, your company and users have to live with the system. Learn how to make sure your company gets what it needs, and not just what the vendor wants to sell.
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