Assessment of Computer System Risk as a Basis for Validation

Instructor: Tim Stein
Product ID: 700356
Training Level: Intermediate
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

In this Validation training specific guidelines will be provided on how to reduce the validation activities for moderate and low risk systems.

A risk based-approach is the most significant means to gain efficiencies in the validation of moderate and low risk systems. The risk level of the system can be used to determine what activities ought to be included in the validation and the rigor and intensity with which those activities are carried out. The FDA guidelines urge regulated companies to base their effort to validate systems on the risks associated with their failure.

In this first of two related webinars, Tim Stein, the author of Computer System Risk Management and Validation Life Cycle, will present a simple method for establishing the system risk level based on the consequences of a failure to meet intended uses. The system risk level is the justification for reducing the validation effort for moderate and low risk systems.

In addition, Tim will present a method to determine the risks associated with the failure of specific functions performed by the system. The risk level of a function determines the extent of validation testing that needs to be performed on the function.

An ERP system is used as an illustration throughout the presentation.

In the second webinar of this two-part series, Tim will provide specific guidelines how to reduce the validation activities for moderate and low risk systems. In addition, specific guidelines will be given for how to reduce the testing of moderate- and low-risk functions.

Areas Covered in the seminar:

  • How to identify the system’s intended uses
  • How to define scales for the severity of harm from a failure, the likelihood of the harm occurring, and the risk level of a system
  • Two methods for determining the system risk level
  • How to determine the risk level associated with the failure of a system to meet individual requirements

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’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.

Related Documents:

1. Life Cycle for the Selection, Implementation, Validation and Use of Computer Systems (RiskVal Life Cycle)

2. Computer System Risk Evaluation for Determining Risk Mitigations, Validation Activities, and the Extent of Testing (RiskVal)

3. Guidance on Validation Activities for Systems at the Low-, Moderate-, and High-Risk Levels (RiskVal)

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
21 CFR Part 11 Compliance for SaaS/Cloud Applications - 80202SEM

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