2 Pre-requisites & Ground Rules Design Control TrainingBring draft of Requirement DocumentsProvide Sources of inputs to generate RequirementsGround Rules:Share work with other teamsTeam learning experience
3 Design Requirements & Analysis Training TopicTime (min)TakeawaysIntroduction10Role of Requirements30Why have good requirements?Benefits of having good requirementsSources & Tools for gathering requirements20Sources of requirementsTools for requirements gatheringCharacteristics of a Quality Requirement StatementCommon Characteristics of a Good Quality RequirementStatementHow to check for a good requirementCritic requirements examplesDesign Control Architecture - PCD60Understanding the PCD - Characteristics & ExamplesApplication through team exerciseLunch & BreaksDesign Control Architecture - SRD90Understanding the SRD - Characteristics & ExamplesDesign Control Architecture - SSRDUnderstanding the SSRD - Characteristics & Examples
4 DI/DO/DTM as part of PDP PlanningDesign Trace MatrixCustomer Requirements (PCD)System & Subsystem RequirementsDesign & DevelopmentVerification & ValidationDesign VerificationDesign OutputDesign ValidationMedical Device
5 Design Requirements as part of PDP Team Training & Activities:PlanningDesign InputRisk ManagementDesign TraceabilityCore TeamFormedReviseDI & PlanningReviewD&D PlanDI DocumentsRAMTDTMStoppedPlanning PhaseProceedDesign &DevelopmentPhaseDevelopmentPhase
6 Design Requirements & Analysis Role ofRequirementsSources & Tools of Requirements GatheringCharacteristics of Quality Requirement StatementDesign Control Architecture:PCD, SRD & SSRD
7 Why Requirements Definition is important? Compliance Automation Inc.
8 The Role of Requirements ‘Who are those guys, anyways?’ A statement(s) of what user capabilities or services a system or product needs to deliverOperational need translated into descriptions, physical and performance parameterObjective, complete, clear, testable
9 The Role of Requirements Why do Specifications Matter? Are they ‘just another deliverable’?What is influenced by requirements?What role do requirements play in development efficiency?What is the regulatory impact with respect to requirements?
10 Planning - Defines the scope and complexity of an effort The Role of Requirements Advantages of Developing Excellent RequirementsCustomer - Understand customer needs, desired outcomes and product intended useTeam – On the same page, pulling in the same direction, common ownershipPlanning - Defines the scope and complexity of an effortTeam members – know what is expected, sets up successful outcomesBusiness – communicate, plan and deliver results
11 The Role of Requirements Consequences of Poor Requirements Lack of a cohesive team effortInability to launch a productLate projects, sliding schedulesCancellation at phase gate reviewUnsuccessful or unacceptable products or services
12 The Role of Requirements Cost Pyramid Field ActionManufacturingVerificationDetailed DesignArchitectureRequirements
13 The Role of Requirements A Case Study Incomplete requirement set on diagnostic device regarding priority of error reporting3 stated requirements1. Requirement for reading > 500 reported as ‘high’ result2. Error trap requirement for insufficient blood (X < 0.006)3. Error trap requirement for blood on wrong side of strip (X > 0.09)Missing requirementPriority of combined errors (1 and requirement 2 or 3)Design assumption madeIncomplete or inaccurate requirement analysisVerification successfulValidation does not show issue (low occurrence)
14 The Role of Requirements A Case Study (Cont) Severe Action TakenField action required – recallAgency investigationsLitigationProbation and penaltiesPotential danger to customersLost opportunitiesDirect financial loss
15 The Role of Requirements Understand the user need and intended use as the basis for design and development:Without understanding the customer requirements (e.g. user needs, intended uses), what are the reasons for design and development?Provide an accurate translation of customer need and intended use to minimize design redundancies:Planning, design decisions and project execution can be done efficiently.Reduces the probability that errors will be introduced through redesign or design omissions
16 The Role of Requirements Create the foundation for product design and development – Product requirements are the cornerstone in providing resultsProduct Development Process:Cycle time reductionProduct quality fulfilling customer need and desired outcomesReduce or eliminate recalls and field actionsIncrease NP revenuesDesign (product and process) improvements:Quality productProcess and performance stability
17 The Role of Requirements Complete definition and management of labeling claims:The Marketing Team will have the competitive advantage in providing the product features to the customers.Availability of information to suppliers for product changes.Better control of the product development process:The development team will be able the manage the project through prioritization.Focus on the essential requirements of the product that will delight the customer.
18 The Role of Requirements Improved quality and end-user satisfaction :Product benefits consistent with customer desiresConsistent performanceImproved, predictable reliabilityImproves Team Communication:Minimizes guess work, interpretation and disconnectsBrings team to the same level of understanding
19 The Role of Requirements Easier compliance with regulations through objective evident:Documented Design Verification and Validation ActivitiesTraceabilityReduces Rework/Redesign/Add Product Features:More efforts can be focus adding Product Features that will delight the customers.Improving the reliability and the quality of the productsGain Market Share:Speed to marketProduct cycle time reduction
20 What’s wrong with this picture? Compliance Automation Inc.
21 Marketing Requirement Document Sources of RequirementsInput Sources to MarketingRequirement DocumentBusiness ProposalRegulatory RequirementsJ&J Business RequirementsCustomer inputTechnology AssessmentMarketing Requirement Document
22 Sources of Requirements Customer - Input Sources for the PCDMarketing Requirement DocumentProduct Criteria DocumentPHA and Preliminary Human Factors AnalysisOperationsProduct Support TeamsCAPAAdditional Input Sources:Regulatory & StatutoryLifeScan Business RequirementsOthers
23 Sources of Requirements (cont.) Product - Input Sources for the SRD & SSRDSystem Requirements DocumentSub-system Requirements DocumentsProduct Criteria DocumentDesign FMEA and Fault Tree AnalysisAdditional Hazards and Human Factors Analysis
24 Sources of Requirements (cont.) Product – Other Input Sources for the SRD & SSRDMarketingCompetitive BenchmarkingLegacy RequirementsInternal BenchmarkingBrainstormingComplaintsTechnical Services GroupCAPAOther Sources
26 Tool for Gathering Requirements Advantages of cause-and-effect diagramIdentify sources of requirementsApply to all levelsFocus on specific issue without resorting to complaints and irrelevancyEasy to useDisadvantages:Relationship not well defineInterrelationships not defined
27 Tool for Gathering Requirements Quality Function Deployment (QFD)Customer to SystemSystem to SubsystemsSystemSubsystemsCustomer (PCD)RelationshipImportanceSystemImportanceRelationshipPriorityPriority
28 Tool for Gathering Requirements Advantages of QFDClear translation of customer requirements into design through logical stepsRobust and applicable to projects of varying size, scope, and complexityAllows user to prioritize and focus on the elements that are critical to quality (CTQ)Able to define complex inter-relationshipProvides the platform for post launch design change control by depicting trace through entire systemForces requirements to be analyzed for ambiguity and redundancyAnalysis for V&V planning done with requirements definitionDisadvantages of QFD:Requires substantial up front investmentRequires specialized training
29 What wrong with this picture? Compliance Automation Inc.
30 Characteristics & How to Check for Goodness Characteristics that Individual Requirement StatementShould Exhibit:NecessaryConciseImplementation FreeAttainableCompleteConsistentUnambiguousVerifiableCorrectFeasiblePrioritized
31 Characteristics & How to Check for Goodness Necessary - The stated requirement is an essential capability, physical characteristic, or quality factor of the product or process. If it is removed or deleted, a deficiency will exist, which cannot be fulfilled by other capabilities of the product or process.One good test of necessity is traceabilityTraceable - You should be able to link each requirement to its source, which could be a higher-level system requirement, risk mitigation, a use case, or a voice-of-the-customer statement. Also link each requirement to the design elements, source code, and test cases that are constructed to implement and verify the requirement. Traceable requirements are uniquely labeled and are written in a structured, fine-grained way, as opposed to large, narrative paragraphs or bullet lists.Concise (minimal, understandable) - The requirement statement includes only one requirement stating what must be done and only what must be done, stated simply and clearly. It is easy to read and understand.
32 Characteristics & How to Check for Goodness Implementation free - The requirement states what is required, not how the requirement should be met. A requirement statement should not reflect a design or implementation nor should it describe an operation.At the system level, requirements can be truly abstract or implementation free. An example of a requirement for a monitor system at the system level is: "The system shall be capable of detecting a power failure.” This sentence should be followed by expected performance data (a quantification of what "detecting" means) against specific power failures. When no specific implementation has been stated, the system designer is free to pursue alternative, competing system designs.
33 Characteristics & How to Check for Goodness Attainable (achievable or feasible) - The stated requirement can be achieved by one or more developed system concepts at a definable cost. This implies that at least a high level conceptual design has been completed and cost tradeoff studies have been conducted.Complete (standalone) - The stated requirement is complete and does not need further amplification. The stated requirement will provide sufficient capability.Consistent - The stated requirement does not contradict other requirements. It is not a duplicate of another requirement. The same term is used for the same item in all requirements.Unambiguous - Each requirement must have one and only one interpretation. Language used in the statement must not leave a doubt in the reader's mind as to the intended descriptive or numeric value.
34 Characteristics & How to Check for Goodness Verifiable - The stated requirement is not vague or general but is quantified in a manner that can be verified by one of these 4 alternative methods: inspection, analysis, demonstration or test.Determine how the requirement will be verified.Alarm example: Within a system, both visual and audible alarms are often required to warn the user about abnormal or unsafe conditions. Also, the same alarm is used for multiple conditions, such as system failure, strip insertion, test results and low batteries.To verify that both the visual and audible alarms work together, all tests must include both. Therefore, the visual and audible parts should be combined into a single requirement. Further, if the conditions providing inputs to the alarm can be incorporated into the same test or demonstration, these should also be included in the same requirement.An example of a requirement following this approach can be "The element shall provide a visual and audible alarm under all conditions listed in Table The alarm shall be activated no longer than 1 second after the condition exists."
35 Characteristics & How to Check for Goodness Correct - Each requirement must accurately describe the functionality to be delivered. The reference for correctness is the source of the requirement, such as an actual customer or a higher-level system requirements specification. A software requirement that conflicts with a corresponding system requirement is not correct (of course, the system specification could itself be incorrect).Only user representatives can determine the correctness of user requirements, which is why it is essential to include them, or their close surrogates, in inspections of the requirements. Requirements inspections that do not involve users can lead to developers saying, "That doesn’t make sense. This is probably what they meant." This is also known as "guessing."
36 Characteristics & How to Check for Goodness Feasible - It must be possible to implement each requirement within the known capabilities and limitations of the system and its environment To avoid infeasible requirements, have a developer work with the requirements analysts or marketing personnel throughout the elicitation process. This developer can provide a reality check on what can and cannot be done technically, and what can be done only at excessive cost or with other tradeoffs.
37 Characteristics & How to Check for Goodness Prioritized - Assign an implementation priority to each requirement, feature, or use case to indicate how essential it is to include it in a particular product release. Customers or their surrogates have the lion’s share of the responsibility for establishing priorities. If all the requirements are regarded as equally important, the project manager is less able to react to new requirements added during development, budget cuts, schedule overruns, or the departure of a team member. Priority is a function of the value provided to the customer, the relative cost of implementation, and the relative technical risk associated with implementation.Three levels of priority:High priority means the requirement must be incorporated in the next product release.Medium priority means the requirement is necessary but it can be deferred to a later release if necessary.Low priority means it would be nice to have, but we realize it might have to be dropped if we have insufficient time or resources.
38 Characteristics of Quality Requirements Other Characteristics of a good RequirementUnique – A requirement should have a unique label, a unique name and unique contents.Documented and Accessible – A requirement must be documented (e.g. writing, pictures, images, database, etc.) and the documentation must be accessible.Identifies Applicable States – Some requirements only apply when the system is in a certain states or modes. If the requirement is only to be met sometimes, the requirement should reflect when.For example: The vehicle shall:Be able to tow 2000-pound cargo trailer at high way speed (65 MPH)Accelerate from 0-60 MPH in less than 10 seconds
39 Requirement Fundamentals Some words to avoid for the SRD and SSRD:Vague and general words be avoided. Avoid "flexible", "fault tolerant", "high fidelity", "adaptable", "rapid or fast", "adequate", "user friendly", "support", "maximize" and "minimize“.For example: "The system design shall be flexible and fault tolerant".Other words that should be avoided are "and/or", "etc." and "may".
40 Requirement Fundamentals Here are some examples of problematic requirements:Original: "The product shall switch between displaying and hiding nonprinting characters instantaneously."Not feasible: Computers cannot do anything "instantaneously".Incomplete: Does not state under what conditions the switching occurs. Does it happen automatically, or as a result of user input?Ambiguous: What does "nonprinting characters" mean? Hidden text? Attribute tags? Control characters?Rewritten: "The user shall be able to toggle between displaying and hiding all HTML markup tags in the document being edited with the activation of a specific triggering mechanism."
41 Requirement Fundamentals Problematic Requirements (cont.):Original: "The software shall be able to clear the monitor after a successful upload."Incomplete: Under what conditions is the monitor cleared? All the time? Or is a specific action required?Ambiguous: What does "clear the monitor" mean?Rewritten: "After a successful upload from the monitor, the software shall query the user as to whether s/he wants to erase the uploaded test records from the monitor's database."
42 Requirement Fundamentals Problematic Requirements (cont.):Original: "The monitor shall be able to store up to 1500 test records."Ambiguous: Does this mean that if the monitor can store more than 1500 records it is in violation of this requirement? Does it mean that if it can only store 1100 records that is okay ?Rewritten: "The monitor shall be able to store at least 1500 test records."
43 Requirement Fundamentals Before & After ExamplesOriginal: "The monitor’s push buttons may be used for optional settings."Ambiguous: What does “may” mean?Rewritten: "Optional settings shall be accessible through the monitor’s buttons.“Original: "The monitor should store test results and errors. Test results include INR result, date, time, and system quality control results."Ambiguous: Should?More than one requirements?Verifiable: How many test results?Rewritten: "The Monitor shall provide storage for a minimum of 75 test results.““Stored test results shall include the date and time stamp, an INR result from 0.8 to 8.0 if testing passes, ‘HI INR’ for high results, ‘LO INR” for low results if a result is reported, or an error code if testing fails. Stored results also include Control 1 and Control 2 values.“
44 Requirement Fundamentals Before & After ExamplesOriginal: "Test strip can hold sufficient sample without overflowing."Attainable: How much is sufficient?Rewritten: "The test strip shall accommodate a variety of sample sizes (20 to 40 micro liter) without the sample overflowing beyond the sample application area.“Original: "The monitor retains test result memory and additional memory without batteries."Ambiguous: What additional memory?Rewritten: "The monitor shall store test results, calibration coefficients, algorithm coefficients, and test strip lot-specific calibration data (calibration codes) in non-volatile memory."
45 Requirement Fundamentals Before & After ExamplesOriginal: "At a rate of one (1) test per week, the monitor indicates a low battery condition with at least four (4) tests remaining."Unclear: How does rate relate to indicator for low battery condition?Rewritten: "The monitor shall indicate a low battery condition with enough remaining power for at least four tests.“Original: "The test strip prevents direct contact between the operator and any of the test strip reagents."Consistent Wording: Use “shall”. Operator is referred to as “user”.Rewritten: "The test strip shall prevent direct contact between the user and any of the test strip reagents."
47 Design Control Architecture – PCD Characteristics:User/Customer NeedsA review of the Customer’s needs based upon Market Research and Focus Groups.Intended UseA review of the claims that will be included in the labeling defining how the device will be used and who the primary end users will be. This could also include hospital guidance and interface requirements with other devices.
48 Design Control Architecture – PCD Characteristics:Regulatory and StatutoryThe domestic and international requirements for the device based upon the intended market, including any regional standards, directives, laws, and regulations.Business NeedsSpecific Requirements mandatory for product acceptability (e.g. COGS, Quality, Reliability, etc.).OthersDesign for ManufacturabilityTestabilityCustomer Service
49 Design Control Architecture – PCD User Needsmonitor CriteriaExamples The monitor shall be easy to turn on an off.Button functions shall be easy to understand and use.The monitor shall automatically turn itself off after a period of inactivity to conserve battery power.monitor display shall be easy to read and visible in normal lighting conditions.The monitor surface shall be easy to clean and sanitize.Test Strip CriteriaExamples The user shall be able to insert the test strip in the monitor easily.The test strip handle area shall be clearly marked.The sample size from a single finger stick shall be sufficient to give an accurate test.The product shall provide accurate results over the stated life of the product if kept in its original packaging.
50 Design Control Architecture – PCD Intended UsesExamples The product is intended for use by health care professionals at the point of care.The product is intended for use by laypersons in the home for patient self-testing.The product shall be used for quantitative measurement of PT in fresh capillary blood as an aid in monitoring oral anticoagulation (Warfarin) therapy.The product shall be used for quantitative measurement of PT in venous whole blood as an aid in monitoring oral anticoagulation (Warfarin) therapy.
51 Design Control Architecture – PCD Regulatory and Statutory RequirementsCertification CriteriaExamples The product shall meet CAN/CSA C22.2 No , Medical Electrical Equipment - Part 1: General Requirements for Safety (equivalent to IEC 601.1) including any applicable collateral standards.International Electro-technical Commission (IEC), IEC , Safety Requirements for Programmable Electronic Medical Devices shall be followed.Labeling and Packaging CriteriaExamples Product labeling, packaging, and documentation shall be readable and understandable.Product packaging and labeling shall include general instructions for how the product shall be used.
52 Design Control Architecture – PCD OthersExamples The Rubicon Monitor shall be marketed in conjunction with the Rubicon Test Strip.The monitor shall be storable and transportable in an acceptable range of environmental conditions.There shall be no user-serviceable components, except for batteries.Removable parts (i.e., test strip holder and batteries) shall be field-replaceable.Replacement parts shall be compatible with all monitors.
53 Design Control Architecture – PCD Team Exercise
54 Design Control Architecture – SRD Characteristics:FunctionalFunctional requirements specify what the design does. Focus is on the operational capabilities, the processing of inputs and the resulting outputs.Physical & PerformancePhysical and Performance requirements specify how much or how well the design must perform, addressing such issues as speed, strength, size, weight, response times, accuracy and precision, limits of operation, etc.InterfaceInterface requirements specify characteristics that are critical to compatibility with external systems (including user and/or patient interface, if applicable).Others
55 Design Control Architecture – SRD FunctionalQC RequirementsExample The monitor shall have the capability of detecting a power failure and shall not display or store result from a test that is in-progress.System RequirementsExample The system shall produce a test temperature at the assay site of 39 +/- 1 ⁰ C.The system shall complete the test and display an INR result or an error message, with time and date stamp, within 2 minutes of sample applicationMonitor RequirementsExample Batteries inserted incorrectly (wrong polarity) shall not damage the monitor.The Monitor shall turn itself off to conserve battery power after at least 90 seconds of being idle while waiting for user action.
56 Design Control Architecture – SRD Physical and Performance Requirementsmonitor RequirementsExample The monitor dimensions shall be no greater than 8.0” long x 3.4” wide x 2.2” high (20.3 cm long x 8.6 cm wide x 5.6 cm high).Test Strip RequirementsExample The test strip dimensions shall allow easy insertion of the test strip to be into the test strip holder.System RequirementsExample The system shall provide accurate results for a temperature range of 15 to 35° C.The physical and performance requirements specify how much or how well the design must perform. The requirement statements address such issues as speed, strength, size, weight, response times, accuracy and precision, limits of operation, etc.
57 Design Control Architecture – SRD Interface RequirementsMonitor RequirementsExamples The monitor shall prompt the user to confirm or reset the CalCode.The monitor shall alert the user if the test strip is inserted incorrectly.Test Strip RequirementsExamples The test strip shall be clearly marked as to the orientation and direction of insertion.The test strip shall prevent direct contact between the user and any of the test strip reagents.Labeling RequirementsExamples Product labeling shall conform to 21CFR820 partProduct labeling shall conform to CAN/CSA C22.2 NoProduct labeling shall contain instructions for the user to properly and safely operate the system.Interface statements specify characteristics that are critical to compatibility with external systems, including user and/or patient interfaces. This section also addresses issues that are relevant to the human factors component.
58 Design Control Architecture – SRD Team Exercise
59 Design Control Architecture – SSRD Subsystem Requirement Documents (SSRD)PRSSRSMRSERSRRSLRSFunctionalPhysical & PerformanceInterfaceGeneral Design Goals & ConstraintsThis slide needs to be checked.
60 Design Control Architecture – SSRD Characteristics:FunctionalFunctional requirements specify what the design does. Focus is on the operational capabilities, the processing of inputs and the resulting outputs.Physical & PerformancePhysical and Performance requirements specify how much or how well the design must perform, addressing such issues as speed, strength, size, weight, response times, accuracy and precision, limits of operation, etc.InterfaceInterface requirements specify characteristics that are critical to compatibility with external systems (including other Subsystem and user and/or patient interface, if applicable).General Design Goals & ConstraintsThis slide needs to be checked.
61 Software Design Constraints General Design ConstraintsRegulatory PoliciesHardware Limitations (e.g. time requirements)Interfaces to Other ApplicationsParallel OperationAudit FunctionsControl FunctionsHigher-Order Language RequirementsHandshake ProtocolsCritical Nature of ApplicationSafety and Security Considerations
62 Software Design Constraints General Design ConstraintsHardwareSoftwareSerial Communication
63 Software Functional Requirements The essential functions provided by the software product. These requirements detail the behavior of the software. They should be grouped according to the product functions specified in the Product Function Overview. Sections may include; General Functions, Power-On and Self-Test, Serial Command Processing, Configuration of monitor Options, Performing a Glucose Test, and Reviewing Stored Data. Each section should contain those requirements associated with that particular function.
64 Software Functional Requirements General Functions Power-On and Self TestSerial CommunicationsSerial Command Processingmonitor ConfigurationData StorageTest ModeCalibration Strip ModeSetup ModeData Review ModeUser Data Management ModeMimic ModeFunctional Tests
65 User Interface Requirements SoftwareUser Interface RequirementsDescribe aspects of the part of the software that interfaces the user to the monitor or application. This might include response time for button presses, debouncing requirements, minimum font size restrictions, standard error message formats, standard objects that must appear on every screen, etc. Do not include screen images or other design information in this section unless they truly represent a required feature.
66 External Interface Requirements SoftwareExternal Interface RequirementsExternal interfaces can include interfaces to hardware components of the system (displays, buttons, sensors, valves, etc), software components of the system (databases, drivers, etc.), or external devices (via serial port or network connection).
67 Performance Interface Requirements SoftwarePerformance Interface RequirementsDescribe the numerical requirements placed on the software or user interaction with the software. Only measurable performance parameter shall be specified (file size, response time, frequency, etc.). Performance requirements for a particular function should be specified in the appropriate “Functional Requirement” section.
68 ElectronicsGeneral Design Goals and ConstraintsElectronic ComponentsSizeWeightYieldCostTestability
84 Labeling on the monitor User NeedsExample: All monitor labeling shall be clearly legible.Regulatory/StatutoryExample: The monitor label shall specify “For In Vitro Diagnostic Use”.LifeScan Labeling RequirementsExample: The monitor label shall include a LifeScan copyright symbol.Owner’s BookletExample: The Owner’s Booklet shall contain instructions for the user to properly and safely operate all components of the system.Example: The Owner’s Booklet shall include all applicable equipment classifications from CAN/CSA M90 Clause 5.Example: The Owner’s Booklet shall include an artwork number.
85 Labeling Logbook monitor Kit Carton Labeling User NeedsExample: The logbook shall provide space to record the result of each test.LifeScan Labeling RequirementsExample: The Owner’s Booklet Addendum shall include an artwork number.monitor Kit Carton LabelingExample: The monitor carton label shall contain the LifeScan Customer Support and Service number.Regulatory/StatutoryExample: The monitor carton label shall include all information appearing on the monitor label.Example: The monitor carton label shall contain LifeScan copyright notice.Labeling on the Test StripsExample: The test strips shall have graphics printed on the top side to aid the user in inserting the strip with the right side up.
86 Labeling POC and PST Test Strip Bottle Labels User NeedsExample: The POC and PST test strip bottle labels shall contain instructions for proper storage.Regulatory/StatutoryExample: The PST test strip bottle label shall contain the “Rx Only” designation.LifeScan Labeling RequirementsExample: The POC and PST test strip bottle labels shall contain relevant patent numbers.POC and PST Test Strip Carton LabelingExample: The POC and PST test strip carton labeling shall have the expiration date prominently displayed.Example: The POC and PST test strip carton labeling shall include a Lot Number.Example: The POC and PST test strip carton labeling shall contain a product number and barcode.
87 Labeling POC and PST Test Strip Package Inserts Intended UseExample: The POC and PST test strip package insert shall state that the product is for use with the monitor.User NeedsExample: The POC and PST test strip package inserts shall provide a quick reference to the steps for performing a test using the monitor INR Monitoring System.Regulatory/StatutoryExample: The POC and PST test strip package inserts shall describe physical, biological, or chemical indications of instability or deterioration of the reagent.LifeScan Labeling RequirementsExample: The POC and PST test strip package inserts shall include an artwork number.monitor Kit Shipping LabelingExample: The monitor shipper labeling shall specify the temperature and humidity ranges for transport and storage of the monitor.Example: The monitor shipper labeling shall contain a product number and barcode.
88 Labeling POC and PST Test Shipper Labeling Instructor’s Guide User NeedsExample: The test strip shipper labeling shall indicate the number of cartons contained in the shipper.LifeScan Labeling RequirementsExample: The test strip shipper labeling shall contain a part number and barcode.Instructor’s GuideIntended UseExample: An Instructor’s Guide shall be created for use in training and certification of PST users.Example: The Instructor’s Guide shall provide written and hands-on exercises to be performed by the trainees.
89 Design Control Architecture – SSRD Team Exercise