In this seminar, you can learn how to save time and money in conducting validations that fully meet regulations
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:
- Which of the activities need to be performed for low- and high-risk systems
- How to modify the rigor and intensity of the validation efforts based on the risk level
- The level of testing that is appropriate for low-, moderate-, and high-risk system
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:
- What validation activities are appropriate for low-, moderate-, and high-risk systems
- How to adjust the rigor and intensity of validation activities based on the system risk level
- How to base the level of requirements testing on the risks associated with system failures
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:
- End-users responsible for applications that need to be validated
- QA managers and personnel
- Information Technology managers and personnel
- Validation specialists
- Consultants
- Quality system auditors
Instructor Profile
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
