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 ApproachUsing 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 quotenow.
Option 3. We Can Create a Customized Risk-Based Validation ApproachProtocol.
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.
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)
Ramon Cayuela, MS, BS, Chemical Engineering
CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!
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