The 10 most common CSV computer system validation deliverables and testing requirements are established based on the application category risk value, for each application functionality.
The first five (5) computer system validation deliverables begin with the system design qualification. The last five (5) computer system validation deliverables end with the system qualification.
- Validation Master Plan. A document that describes how and when the validation program will be executed in the whole facility.
- Validation Plan. A document that summarizes the entire project, identify measures for success, and clearly defines criteria for final acceptance and release of the system.
- User Requirements Specification. This describes what the system should do.
- Functional Specifications. This document describes the detailed functions of the system, i.e., what the system will do to meet the requirements.
- Risk Assessment. A risk-based validation approach for each functional category.
- Installation Qualification, IQ:– Protocol and Report
- Operational Qualification OQ, – Protocol and Report
- Performance Qualification PQ.- Protocol and Report
- Traceability Matrix, The traceability matrix is a document that links all requirements sections with the test scrips sections from each validation document.
- Validation Plan Report – It should summarize the whole validation activities performed, any deviations from the validation plan, any outstanding and corrective actions, and a statement of fitness for the intended use of the system.
Computer system validation should not be confused with any other validation requirements, such as process validation for an automated manufacturing process.
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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 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 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)