Software validation is difficult because testing can be forever, and it is hard to know how much evidence is enough. Therefore, software validation is a matter of developing a “level of confidence” that the device or system meets all requirements and user expectations for the software automated functions and features of the device. So, it very important to understand what is the confidence level in software validation.
Several techniques are all used to develop an acceptable level of confidence before shipping the product. The level of confidence, and therefore the level of software validation, verification, and testing effort needed, will vary depending upon the safety risk (hazard) posed by the automated functions of the device.
For more information about how to determine the software risk and its categories, click here.
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SOFTWARE RISK CONFIDENCE LEVEL
For more details on specific FDA expectations and how to perform a Computer System Validation, follow us.
Three (3) Options to Create a Computer System Validation 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 Computer System Validation 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 quotenow.
Option 3. We Can Create a Customized Computer System Validation 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.
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!