Training: Software Development in Regulated Space
Training courses for developing software in regulated space. Workshops on how to develop and write system and software requirements, and validation and verification strategies with practical and real-world solutions.
LabVIEW [Software] Development in Regulated Space 2 Day
Experience Level 2 years minimum in LabVIEW
The course is to provide practical guidelines and coding techniques for developing LabVIEW code in regulated space. Divided into two parts of; creating software requirements [SRS] and specifications to practical and actual LabVIEW coding techniques for developing code in regulated space. The course is interactive and provides free software toolkits for coding in regulated space.
Learn how to develop requirements and test/validation protocol development, targeted for experienced LabVIEW developers and Quality engineers who have to create software requirements, but have no Programming/LabVIEW experience.
The goal of the course is for those approaching software development in LabVIEW or overseeing software development in regulated space to develop fundamental and practical understanding and skills on how to approach, develop and manage software development in regulated space.
Instructor is Jack Hamilton, of C6 Systems, Inc with 30 years experience in LabVIEW software development and FDA consulting. Mr. Hamilton has and continues to work for numerous fortune 500 medical device companies in the US, developing software and consulting in FDA validation for medical devices.
Coding Skills in Regulated Space [2 Days]
Code Architecture: Robust frameworks
Encapsulate and compartmentalize code functions for easier development and validation testing
Data acquisition and processing coding guidelines
Code configuration; storing configuration and settings, best practices
Error handling: Guidelines and error handling toolkit
Data and Settings file management techniques in the application code
Hardware configuration management in the application code
Meta tagging requirements in your LabVIEW project
Software Requirements Development 1 Day [Part 1]
Ideal for Quality individuals or Programmers new to Validation
How to define, develop and create software requirements. Including practical and actual wording to use to create clear, concise and testable requirements. How to think about wording and structuring requirements to streamline the development, test and validation process.
Unblock writers block: Concise practical instruction on how to create requirements and specification wording. Interactive instruction on how to think about and create requirement declarations. Numerous examples of actual requirements, Validation and test protocol wording as cliff notes.
Tips and Techniques for developing software requirement documents. Example template of Software Requirement Documentation. Brief overview of MSWord techniques for document formatting and requirement tracking.
Validation Test Development [Part 2]
How to create Test validation protocols. Understanding of what essentially are the goals of developing and writing requirements. Actual examples in a streamlined format. How to create a clear path from the requirement on paper through code development to the final code validation testing.
Tips and Techniques for executing validation protocols. Example templates of validation protocols. Brief overview of MSWord techniques for document formatting and requirement tracking.
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