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Questions and Answers
What is the main purpose of the Verification and Validation (V&V) process at Compass Health?
What is the main purpose of the Verification and Validation (V&V) process at Compass Health?
When does the Verification and Validation (V&V) process occur during product development?
When does the Verification and Validation (V&V) process occur during product development?
Which document governs the V&V activities at Compass Health?
Which document governs the V&V activities at Compass Health?
What type of activities are included in the Verification and Validation (V&V) process?
What type of activities are included in the Verification and Validation (V&V) process?
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Which SOP governs the distribution and feedback process at Compass Health?
Which SOP governs the distribution and feedback process at Compass Health?
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Which standard relates specifically to medical device software life-cycle processes?
Which standard relates specifically to medical device software life-cycle processes?
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What is one of the responsibilities of the QA role in the verification and validation process?
What is one of the responsibilities of the QA role in the verification and validation process?
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What must be approved by QA to ensure traceability to requirements and risk analysis?
What must be approved by QA to ensure traceability to requirements and risk analysis?
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Which acronym stands for 'Verification and Validation'?
Which acronym stands for 'Verification and Validation'?
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Which document title corresponds to the process for feedback and customer satisfaction?
Which document title corresponds to the process for feedback and customer satisfaction?
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Study Notes
Compass Health SOP: Verification and Validation
- This SOP outlines the verification and validation (V&V) process for medical device production at Compass Health
- The V&V process is crucial throughout product development, starting early in design and continuing near completion
- V&V activities employ various methods, from design reviews to analyses, inspections, demonstrations, and tests.
- The process ensures all design and development outputs meet customer requirements
- Scope includes V&V activities throughout the product design phase, ensuring that design and development meet input requirements
- Production process is governed by SOP: Process Validation (QMS-SOP-0017).
- Distribution and feedback are governed by SOPs: Post Market Surveillance (QMS-SOP-0030) and Feedback and Customer Satisfaction (QMS-SOP-0022).
- Applicable standards and regulations include FDA QSR § 820.30 Design Controls, ISO 13485:2016 Section 7.3 Design and Development, IEC 62304:2015 Medical Device Software – Software Life-cycle Processes and TG (MD) R Sch3 P1 Cl 1.4(4)& (5)(c)
- Different roles (Engineering, QA, Product) have specific responsibilities related to different aspects of verification and validation, including defining strategies, conducting activities, and ensuring coverage.
- V&V process proceeds according to a high-level flow chart(Figure 1), typically with review gates
- The V&V plan details all V&V activities for a given product
- QA approves V&V plans ensuring requirements, risk analysis and hazard mitigations(product Risk Management Plan are covered)
- V&V activities occur throughout different product development phases and development methods (Agile/Traditional).
- V&V activities are documented at each phase, and product V&V plans are regularly monitored.
- Compass uses different V&V methods (e.g. Review of Design, Analysis, Inspection , Demonstration , Tests, Clinical/Performance Evaluation) depending on the complexity of the task and specific requirements
- Review of design, analysis, inspection, demonstration, and testing are different V&V methods
- Methods are selected in agreement with QA, Engineering and/or Marketing (for labelling and packaging).
- Clinical or performance evaluations take place after successful verification to validate safety and performance.
- Production and Distribution SOPs validate production and distribution processes
- Traceability methods document connections between tests and requirements for each product and new features.
- Quality records such as V&V plans and test results are maintained
- Product development plans specify which phase of the review needs which V&V activities.
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Description
This quiz tests your understanding of the Verification and Validation (V&V) process at Compass Health. Learn about the purpose, timing, governing documents, and responsibilities involved in V&V activities during product development. Dive into the specifics of the standards and SOPs guiding these processes.
