This article describes how to select CSV testing and priority level based on the risk analysis results considering the potential failure severity, occurrence, and detectability.
A risk-based validation approach for each functional category can be established once the risk assessments for individual functional items from the URS have been determined.
The following best practice approach outlines three types of validations that can be utilized with a risk-based process.
- High: Complete/comprehensive testing required. All systems and sub-systems must be thoroughly tested according to a scientific, data-driven rationale. This is similar to the ‘classic’ approach to validation. Furthermore, enhancement may be needed to improve the detectability of failure via in-process production controls.
- Medium: testing of the functional requirements per the URS/FRS required with sufficient assurance that the item has been properly characterized.
- Low: No formal testing needed, but the presence (detectability) of the functional item may be required.
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Three (3) Options to Create a Risk-Based Validation Approach Protocol:
Option 1. You Can Create a CSV Protocol, using a Template.
You can download samples of the validation templates in .pdf format.
To see the complete list of the most popular validation templates, click here.
In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill and adapt to your needs.
Option 2. We Can Bring You a Formal Training on How to Perform Risk-Based Validation Approach Using Our Template(s).
This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections. It includes the template, an exam, and a training certificate for each assistant. Request a quote now.
Option 3. We Can Create a Customized Risk-Based Validation Approach Protocol.
One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.
References: Risk-Based Validation Approach
Food and Drug Administration References
- Glossary of Computerized System and Software Development Terminology (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 1995)
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002)
- Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices (FDA, Center for Devices and Radiological Health, 1999)
- Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems ApproachExternal Link Disclaimer (FDA 2002)
- The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (http://www.ispe.org/gamp/)
- ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000)
- ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001)