Validation Procedure
VaP
Misc.
VaSR
DTM
Misc. Cont'd
100
What is a User Need?
What is a clinical workflow or use case that is used as input to device design. Depending on the tool being used, a user need may also be referred to as a use case.
100
True or False
Any user can execute a test case?
False
The user must have the credentials of the actor defined for the specific test case.
Bonus:
What is the reference doc for Actors?
DND05L01 - Actors List
100
Who are the approvers for the Validation Plan?
Who are validation and product management.
100
True or False:
We capture Non-Clinical External Evaluation results?
True
We capture NCA and Usability results in the Validation Run of Record Section.
100
True or False
A validation design trace matrix is required?
True:
There is a traceability section in the VaSR. It can be included in VaSR or a separate document.
100
What procedure defines how discrepancy reports are logged?
What is DND15 - Discrepancy Report DR Handling
200
What is Solution Validation?
What is a test level where the device is validated in a solution context: The solution contains more interacting devices in order to validate the interoperability of device under test in an end-to-end manner. Solution validation typically covers a treatment scenario capability, containing one or more devices, in an end-to-end level.
200
Which UX activities happen prior to Validation TRR?
What is Usability - Formative Testing.
200
Who is responsible to drive the coordination of validation activities and track status of validation deliverables?
Who is Project Management.
200
What milestone must the VaSR be completed by?
What is prior to DOR.
200
Explain the options of Reportable and Mandatory for Diagnosis Codes
Reportable- This can be selected to assist with the monitoring of threats or outbreaks to a public health agency. This is option able
Mandatory- indicates it is mandatory to be reported to a health agency
200
Which support activities happen throughout the project?
What are:
Issue/DR reviews and testing
Design and Document Reviews
User Experience Support
Non-Clinical External Product Evaluation Support
Cross Functional Meetings
300
What type of Risk Control Measures do we validate?
What is human operated risk control measures.
300
What input is required for Validation TRR test round #2?
What is:
Impact Analysis and validation Regression analysis complete.
Validation TRR 2 is passed.
Bonus Point:
Where is this impact analysis and regression analysis documented?
300
Where can you find the list of stakeholders for a project/release?
300
Where are Quality Targets defined?
What is the DDP/SDP.
300
True or False
To add drugs to the Users favorite drug list, these drugs must be listed in the Formulary.
False -
For drugs to be added to the User's favorite drug list- they must only be included on the Master favorite drug list.
300
What are the Validation DOR deliverables?
VaSR
Validation DTM
Issue/DR Summary Report (UA review reports)
Validation Test Results
400
What teams should be consulted in validation preparation?
Who are:
Design Validation
Product Management
Risk Management
User Experience
User Assistance
Global Operations teams
Helpdesk and Applications
Medical Affairs
Product Marketing
Packaging Validation
Verification Lead
400
What activity is the Validation Lead responsible for prior to DIR/PSR/Inception Phase?
What is Validation Plan Rev 01.
400
Which RCMs are validated during Summative testing identified?
Where are the test results documented?
What are medium to high human-operated RCMs.
What are test reports captured in the VaSR.
400
Who do we consult for DR targets?
Who is Design Implementation and PdM.
Bonus:
What report do we consult for DR targets?
What is the Defect Summary Report.
400
What template guides us on what should be included in a DTM?
What is DND0603.
400
How do you request a doc ID?
What is the document numbering application.
DHF VOS - # of numbers your requesting (max is 40)
500
What are the responsibilities of the Validation Lead?
What is the Individual who:
Defines and updates the validation plan throughout the project.
Participates in and contributes to design input, design change and risk reviews as appropriate.
Ensures that the Validation Test Protocols are defined.
Ensures that the Validation Test Environment is defined, established and available to perform the validation.
Ensures that the persons performing validation have qualifications and experience suitable of the actor roles required for validation.
Ensures that the activities as defined in the Validation Plan are executed and tracked to completion
Supports Internal and External Domain Experts with test execution and defect logging.
500
How do you determine which validation activities are identified in the schedule section?
What is, the schedule section identifies all activities in scope for the release as identified in section 2.11 Validation Activities Table.
500
What type of environment is used for validation run of record?
What is production equivalent.
500
How is it determined if a deviation must be documented?
What is, if the validation activities described in the validation plan differs from the validation activities completed.
500
Where must physicians be registered to qualify to do EPCS? (E-Prescribing Controlled Substances)
With Surescripts & Dr. First
500
What is compatibility vs interoperability?