Verification and Validation SOP PDF

Compass Health AI SOP: Verification and Validation Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author +BO Yangzom QA/RA James Approver...

Compass Health AI SOP: Verification and Validation Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author +BO Yangzom QA/RA James Approver +BO Baskin COO Kevin Approver +BO Kennedy Engineering Document# QMS-SOP-0009 Revision History Version Date Description 1.0 03-Jan-2024 Initial Release Document# QMS-SOP-0009 1 Introduction Verification and Validation (V&V) is of critical importance to production of quality medical devices at Compass Health. The V&V process is performed at all phases of product development, with elements occurring early in the design phase, and other elements occurring near the end of development on representative articles manufactured using production tooling by production personnel. 1.1 Scope This SOP governs all V&V activities at Compass through the product design phase to ensure that the design and development outputs have met the design and development input requirements. V&V includes tests as well as other activities, aimed at verification and validation that products meet safety, efficacy, and customer requirements. Production process is governed by SOP: Process Validation (QMS-SOP-0017). Distribution and feedback are governed by SOP: Post Market Surveillance (QMS-SOP- 0030) and SOP: Feedback and Customer Satisfaction (QMS-SOP-0022). 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure:  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  TG (MD) R Sch3 P1 Cl 1.4(4)& (5)(c) Document# QMS-SOP-0009 2.2 Reference Documents Document Title Document # SOP: Process Validation QMS-SOP-0017 SOP: Post Market Surveillance QMS-SOP-0030 SOP: Feedback and Customer Satisfaction QMS-SOP-0022 3 Acronyms and Definitions Table 1: Acronyms Acronym Meaning ANSI American National Standards Institute ASQ American Society for Quality FAI First Article Inspection QA Quality Assurance SOP Standard Operating Procedure V&V Verification and Validation Document# QMS-SOP-0009 4 Process Roles Role Description of Responsibilities  Defines the strategies and procedures for verification and Engineering validation of requirements  May conduct verification and/or validation activities  Ensures coverage of requirements in verification and validation QA activities  May conduct or witness verification and/or validation activities  May conduct validation activities for elements of the product Product requiring non-clinical validation 5 Verification and Validation Process The V&V process proceeds at a high level according to Figure 1. Typical, but not exhaustive, V&V activities are shown beneath each stage. Document# QMS-SOP-0009 Figure 1: High Level V&V Process Flow The verification and validation activities for a product are defined in the product’s V&V Plan. QA shall approve V&V plans to ensure coverage and traceability to requirements, risk analysis and hazard mitigations (as identified in the product Risk Management Plan). V&V activities will occur at various times, depending on the phase of the product development. Commonly, these activities form input into development review gates. This does not imply a particular structure to those development activities and reviews. For example, while software products at Compass are developed under an Agile framework, physical products are developed under a traditionally staged development. Both of these development and management methods require similar levels of V&V to ensure quality, with the difference being the level of granularity and frequency. Agile includes more validation and verification of requirements and designs at a low level and iterates much more frequently to ensure quality is maintained throughout. Traditional staged development conducts V&V activities in more discrete intervals. Compass conducts reviews on suitability of requirements, designs & component specs, processes, and final products. Product development plans define exactly what phase reviews require which V&V activities. Document# QMS-SOP-0009 V&V activities at Compass comprise a number of methods at a high level. Which method to use in verification or validation is selected by agreement between QA and Engineering (in the case of technical requirements), or QA and Marketing (in the case of labelling and packaging). The V&V methods comprise, in rough order of complexity:  Review of Design (RoD) – the design is reviewed in light of a particular requirement to ensure the design could, if constructed, meet the requirement.  Analysis – where a specific performance metric is required, analysis can be used to show that it should be achievable with the system as designed. Examples of this include error budget analysis using test data from prototypes, physics first- principles, analysis of perturbations, and software simulations with test or synthetic data.  Inspection – a finished product or element may be inspected. Generally, this method is used to verify and validate requirements that something is present (or not present), such as specific labelling, or a specific property, such as dimensional tolerances, etc. This inspection may be as simple as a First Article Inspection (FAI) on marketing materials, or as extensive as an ANSI/ASQ statistical sampling plan.  Demonstration – Often, a requirement will be for a repeatable capability or action without a performance or uncertainty element. Demonstration of the behavior using representative systems later in design, and finally a completely finished device, serves to verify that the requirement has been met. Examples would be demonstrating that a device presents measurements using metric units, or that packaging of a specific type has been employed.  Test – for requirements with a performance element (e.g. speed, accuracy, strength & stiffness, etc.), tests are warranted. The test is performed on completed or representative systems. If testing poses some risk to a device that will ultimately be sold, appropriate pre-test readiness reviews and post-test checks should be indicated. This is not required for product that undergoes destructive testing like Compass’s fiducial markers. Test-based V&V can be single article or may involve ANSI/ASQ sampling plans for batch/lot-based products.  Clinical/Performance Evaluation- Generally performed with a verified build (after successful completion of Verification of the device) to ensure that the resulting product is capable of meeting the requirements for the specified application. The assessment and analysis of clinical data pertaining to a medical device is used to validate the clinical safety and performance of the device when used as intended by Document# QMS-SOP-0009  the manufacturer (intended use). Examples include clinical studies, user acceptance testing (UAT), and any other methods as appropriate. These methods are selected on a per-activity basis, where an activity is aimed at verifying or validating one or more requirements. The focus of V&V is to ensure during development that quality is considered paramount at every phase, retiring risk as early as possible in the development process. Requirements may be indicated for more than one V&V method 6 Production and Distribution Validation of production and distribution processes shall be conducted to ensure ability to produce and deliver product successfully to customers. 7 Traceability Traceability between tests and requirements are documented for each product and new product features. 8 Process Monitoring Quality Assurance approves product V&V plans and regularly monitors results and records of V&V activities. 9 Quality Records Record type Description Identification of strategies and approaches for verification and V&V Plan validation of requirements Test Results Records of verification and validation conducted Document# QMS-SOP-0009 Document# QMS-SOP-0009