Using LabVIEW and TestStand in Regulated Industries Course

Publish Date: Oct 16, 2015 | 0 Ratings | 0.00 out of 5 | Print

Overview

This page describes the Using LabVIEW and TestStand in Regulated Industries training course offered through NI Training and Certification.

Register online at ni.com/training or contact us in one of the following ways

  • call: (800) 433-3488
  • fax: (512) 683-9300
  • email: info@ni.com
Outside North America, contact your local NI Office. Worldwide Contact Info: ni.com/global.

Table of Contents

  1. Course Outline
  2. Suggested Next Courses
  3. Using LabVIEW and TestStand in Regulated Industries Course Outline

1. Course Outline

As product complexity increases and development time compounds, software engineering processes grow even more important to the success of any test and automation project. In addition, regulatory requirements, such as those in the medical device industry, demand efficient and reliable development processes to address safety, business, and regulatory risk considerations.

Taught by experts in the medical device regulatory space and NI products, this course helps learners navigate regulatory requirements and business demands when using LabVIEW for test and automation for medical devices. This course examines FDA regulatory requirements and delivers best practices for reducing the burden commonly felt during computer software validation and test method validation activities.

Duration
  • Instructor-led Classroom: Two (2) Days + Optional day of TestStand
Audience
  • Design verification engineers
  • Manufacturing test engineers
  • People on Software Quality or Design Assurance teams who review code written in LabVIEW or TestStand
Prerequisites
  • Basic understanding of LabVIEW and the environment.  LabVIEW programming experience is not essential for this course, but helpful
  • Some familiarity with FDA regulations and rigors of working in the medical device industry or other highly regulated industry
NI Products Used During the Course
  • LabVIEW Professional Development System
  • LabVIEW Unit Test Framework Toolkit
  • LabVIEW Desktop Execution Trace Toolkit
  • NI Requirements Gateway
  • TestStand

After attending this course, you will be able to:

  • Validate LabVIEW applications
  • Make strategic design decisions to minimize the impact of validating and revalidating LabVIEW applications
  • Implement process improvements and best practices to increase the rigor of validation yet decrease the pain associated with validation

 

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2. Suggested Next Courses

  • Object-Oriented Design and Programming in LabVIEW
  • Managing Software Engineering in LabVIEW

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3. Using LabVIEW and TestStand in Regulated Industries Course Outline

Lesson Overview Topics
Regulatory Landscape This lesson discusses the history, purpose, and aim of the Food and Drug Administration (FDA).  Smart, pain-free regulatory compliance starts with understanding the agency and why they promulgate the regulations you must follow.  
  • FDA History and Mission
  • Safety and efficacy
  • Paths to market
  • FDA enforcement powers
The Quality System: 21CFR820 and ISO13485 In this lesson you will learn about United States and European Quality System Regulations and which parts apply to you as a test engineer.
  • 21CRF820 and ISO13485
  • Testing scenarios during the product life cycle
  • Deep dives into targeted regulations
Risk Management Everything traces back to safety and efficacy.  This lesson takes an in-depth look at risk.
  • Risk to whom?
  • Finding and quantifying risk
  • Controlling and managing risk
21CFR820.70(i) and Software Validation Software that automates the quality system or the manufacturing process shall be validated to an intended use.
  • Validation vs. verification
  • DQ/IQ/OQ/PQ
  • Validation planning and execution
Change Management and Revalidation Change will happen.  Revalidation does not have to be overly burdensome.
  • Software change control
  • Impact assessment
  • Targeted revalidation
21CFR820.72 and Test Method Validation This lesson describes how test method validation can be encompassed by the software validation activity or in some cases avoided by clever design.
  • What is Test Method Validation (TMV)?
  • Instrument specifications
  • Leveraging the calibration process

 

21CFR11 and Good Documentation Practices The dreaded 'Part 11’ is applicable.  But it is not something to fear.  This lesson demystifies Part 11 and gives tactical advice on how to meet Part 11 head on.
  • Good Documentation Practices
  • GDP and Part 11
  • ‘Predicate Rules’
  • Making Part 11 simple

 

Automate DQ with VI Analyzer, Execution Trace, and LabVIEW Compare and Merge Tools In this lesson, you learn how to streamline Design Qualification activities and take credit for good software development processes.
  • Source code control
  • LabVIEW compare and merge tools
  • Coding standards and code reviews
  • VI Analyzer verifies design rules
  • Desktop Execution Trace Toolkit supports DQ
Automate IQ with Object-Oriented Programming and a Hardware Abstraction Layer (HAL) Installation Qualification can be costly if repeated often.  Minimize tester downtime with easy to automate IQ protocols.
  • Decouple application layer from hardware with a HAL
  • Hallmarks of a good HAL
  • Automating IQ with a HAL
Automate OQ with LabVIEW Unit Test Framework Let LabVIEW work for you.  Writing code is only part of the job.  Validating your software is as important and can take over twice the time.  Learn how to streamline validation and revalidation with the LabVIEW Unit Test Framework.
  • What is unit testing?
  • Automate the Validation Protocol
  • Validate your HAL with the LabVIEW Unit Test Framework
  • Verify child class plugins with the LabVIEW Unit Test Framework
Good Tester Design Minimizes PQ Performance Qualification can be minimized by selecting the correct instrumentation and using it as intended.
  • Revisit TMV
  • Can calibrate accuracy but not precision
  • Mitigate Human Error
  • GR vs GR&R
  • PQ
  • Instrument Suitability Assessment
Trace Matrix with Requirements Gateway Do the work up front and generate your trace matrix with the push of a button.
  • How to apply selected TestStand tools and concepts to meet FDA regulations
What is TestStand? This lesson examines TestStand and emphasizes key concepts from the NI TestStand training courses.  These concepts are reexamined under a regulatory compliance lens.
  • Sharing data between deterministic and non-deterministic processes
  • Sharing data between non-deterministic processes.
How TestStand Makes Validation Easier Let TestStand do the heavy lifting so you can focus on writing your test.  Certain TestStand customizations are commonly found across many industries.  This lesson walks through example validations of TestStand architectures commonly found in the field.
  • Streamline DQ with the TestStand Sequence Analyzer and File Diff and Merge Utility
  • Validating TestStand customizations
  • 21CFR820.70(i) as it applies to testing processes
  • 21CFR11
  • Tying it all together

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