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.
