How to know when is a Computer System Validation applicable?
As you may suspect, a computer system validation is expensive, time-consuming, and not necessary in all cases.
Therefore, it is important to identify when is required a computer system validation or not.
The CSV is required whenever software is used to design, develop, or manufacture medical devices, pharmaceuticals, or GMP products.
- Software used as a component, part, or accessory of a medical device;
- Software that is itself a medical device (e.g., blood establishment software);
- Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
- Software used in the implementation of the device manufacturer’s quality system (e.g., software that records and maintains the device history record).
Statutory and Regulatory Requirement
General Principles of Software Validation; Final Guidance for Industry and FDA Staff
For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy. (See Title 21 Code of Federal Regulations (CFR) Part 820, and 61 Federal Register (FR) 52602, respectively.)
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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 Provide you Training When is Required a Computer System Validation.
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 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.
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)