The document discusses challenges in healthcare software development and testing, and how the Inflectra platform addresses them. It outlines Inflectra's compliance features like electronic signatures, traceability, risk management and audit trails. These features help customers streamline development while maintaining compliance with regulations. The presentation then demonstrates SpiraPlan and SpiraTeam's requirements management, testing, documentation and risk management tools.
4. ®
®
What are some of the top challenges?
Whether developing medical devices, conducting medical
trials, managing patient data, or coordinating care,
compliance is critical.
Health and life science industries are heavily regulated, and
the regulations are constantly changing.
Companies constantly need to perform continuous testing
and validation, with real-time traceability.
The current pandemic shows that you have be adaptable to
real-time needs, but maintain compliance
8. ®
®
General Best Practices (1)
Avoid manual paper methods as much as possible
Having to manually “glue” together different artifacts such as
Excel Spreadsheets and Word documents
Easy to miss patterns and deficiencies
Create an integrated process across your disciplines:
Requirements > Testing and Quality
Requirements > Development and Change Management
Risk Management
Documentation Management
Have a single source of truth with integrated traceability
9. ®
®
General Best Practices (2)
The source of “truth” should be the system
Generate your documentation from the system
Don’t let people work “around” the system
Change the concept of requirements from being a document
to being a set of data that can be used to inform all other
activities.
Ensure the system is configured to match your process
Workflows, approvals and electronic signatures are key.
10. ®
Overview of the Inflectra
Platform
What Inflectra offers and how the different parts fit together
13. ®
®
SpiraPlan®
Agile Program & Portfolio Management
SpiraTeam®
Application Lifecycle Management (ALM)
Introducing the Inflectra® Suite
SpiraTest®
Requirements, Test Management
& Bug Tracking
KronoDesk®
IT Support & Help Desk
Rapise®
Test Automation (Web, GUI, Services)
TaraVault® - Source Code Management
SpiraCapture™
Exploratory Testing
14. ®
®
SpiraPlan – Enterprise Program
Management
SpiraPlan®
Agile Program & Portfolio Management
SpiraTeam®
Application Lifecycle Management (ALM)
SpiraTest®
Requirements, Test Management
& Bug Tracking
TaraVault® - SCM Using Git or Subversion
Enterprise
Project
Team
See Spira Comparison Matrix for a comparison on the different editions
17. ®
®
Healthcare & Life Sciences
Electronic signatures for FDA 21 Part 11 compliance
Secure hosting with support for HIPAA BAA agreements
End to end traceability of requirements, tests, and code
Validated platform where you control update cadence