FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”
The software development process should be sufficiently well planned, controlled, and documented to detect and correct unexpected results from software changes. The documentation and reports should cover the relevant steps of the validation life cycle.
Industry guidance for computer system validation is the GAMP Guide, now in its fifth edition and known as GAMP5 published by ISPE (2008). This guidance gives practical advice on how to satisfy regulatory requirements. https://ispe.org/publications/guidance-documents/gamp-5
Software validation is a requirement of the Quality System Regulation (QSR) of the validation life cycle which includes the following elements:
As per FDA guidance document Part 11, Electronic Records; Electronic Signatures, it intends to enforce provisions related to the following controls and requirements in software validation:
- limiting system access to authorized individuals
- use of operational system checks
- use of authority checks
- use of device checks
- the determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks
- establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures
- appropriate controls over systems documentation
- controls for open systems corresponding to controls for closed systems bulleted above (§ 11.30)
- requirements related to electronic signatures (e.g., §§ 11.50, 11.70, 11.100, 11.200, and 11.300)
Statutory and Regulatory Requirement: Software Validation
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 Software Validation Protocol:
Option 1. You Can Create a Software Validation 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 Software 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 Software 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)