The FDA guidelines urge regulated companies to base validation efforts on the risks associated with system failures. Yet most companies do the same thing to validate each of their systems.
A risk based-approach is the most significant means to gain efficiencies in the validation of moderate- and low-risk computer systems. The FDA guidelines urge regulated companies to base validation efforts on the risks associated with system failures. Yet most companies do the same thing to validate each of their systems.
In this seminar, you can learn how to save time and money in conducting validations that fully meet regulations. In a recent validation of an ERP system, for example, a risk based approach resulted in the need to test only 20% of the requirements related to regulatory activities.
In this second of two related webinars, Tim Stein will review the computer system validation activities and discuss:
This presentation is based on the RiskVal(SM) Life Cycle described by Tim in his recent book: The Computer System Risk Management and Validation Life Cycle. This volume was published in 2006 by Paton Press. See [www.patonpress.com]
An ERP system is used as an illustration throughout the presentation.
In the first webinar of this series, Assessment of Computer System Risk as a Basis for Validation, Tim Stein presented methods for determining the system risk level, and risks associated with the failure of a computer system to meet requirements. These analyses are assumed in this second webinar.
Areas Covered in the seminar:
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
Tim Stein, Ph.D., is the founder and CEO of Business Performance Associates, Inc. (BPA), a consulting firm that specializes in both quality systems for biomedical companies and computer system validation. Tim is the author of Computer System Risk Management and Validation Life Cycle which is scheduled for release in April 2006 by Paton Press. Tim has written a set of policy and procedure documents and templates for computer system validation that are available through ComplianceOnline.
Tim brings a rare combination of knowledge to computer system validation. He has in-depth knowledge of software engineering, computer system implementation, the regulatory requirements and guidance documents for software development and validation, and quality system requirements. In the late 80’s, as a quality manager with Tandem Computers, Tim was responsible of supporting 250 software development companies in improving the quality of their products. For the past twelve years, Tim has helped regulated companies establish compliant quality systems and validate computer systems. He also has help companies obtain the ability to validate systems by providing tools and training.
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