Software validation is a critical tool used to assure the quality of device software and software automated operations. Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.
Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes. Software maintenance can represent a very large percentage of the total cost of software over its entire life cycle. An established comprehensive software validation process helps to reduce the long-term cost of software by reducing the cost of validation for each subsequent release of the software.
Table of Contents
SECTION 1. PURPOSE
SECTION 2. SCOPE
2.1. Applicability
2.2. Audience
2.3. THE LEAST BURDENSOME APPROACH
2.4. Regulatory Requirements for Software Validation
2.4. Quality System Regulation vs Pre-Market Submissions
SECTION 3. CONTEXT FOR SOFTWARE VALIDATION
3.1. Definitions and Terminology
3.1.1 Requirements and Specifications
3.1.2 Verification and Validation
3.1.3 IQ/OQ/PQ
3.2. Software Development as Part of System Design
3.3. Software is Different from Hardware
3.4. Benefits of Software Validation
3.5 Design Review
SECTION 4. PRINCIPLES OF SOFTWARE VALIDATION
4.1. Requirements
4.2. Defect Prevention
4.3. Time and Effort
4.4. Software Life Cycle
4.5. Plans
4.6. Procedures
4.7. Software Validation After a Change
4.8. Validation Coverage
4.9. Independence of Review
4.10. Flexibility and Responsibility
SECTION 5. ACTIVITIES AND TASKS
5.1. Software Life Cycle Activities
5.2. Typical Tasks Supporting Validation
5.2.1. Quality Planning
5.2.2. Requirements
5.2.3. Design
5.2.4. Construction or Coding
5.2.5. Testing by the Software Developer
5.2.6. User Site Testing
5.2.7. Maintenance and Software Changes
SECTION 6. VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE
6.1. How Much Validation Evidence Is Needed?
6.2. Defined User Requirements
6.3. Validation of Off-the-Shelf Software and Automated Equipment
APPENDIX A - REFERENCES
Food and Drug Administration References
Other Government References
International and National Consensus Standards
Production Process Software References
General Software Quality References
APPENDIX B - DEVELOPMENT TEAM
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A Software Quality Assurance Engineer is involved in the entire software development process to ensure the quality of the final product. This can include processes such as requirements gathering and documentation, source code control, code review, change management, configuration management, release management and the actual testing of the software. Software QA is often confused with Software Testing, but should not be. Testing is a big part of Software Quality Assurance, but it is not, by any means, the only part of it.click here
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