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.

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March 7th, 2018 – Adam Sandman

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Agenda
 Challenges around Development & Testing in Healthcare
 Best practices in Software Requirements & Testing
 Overview of the Inflectra Platform
 SpiraTeam & SpiraPlan Compliance Features:
 Electronic Signatures
 End-to-End Traceability
 Audit Trails
 Risk Management [SpiraPlan]
 Q&A

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Challenges around Development
& Testing in Healthcare

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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

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What are some of the top challenges?
 Validation of all systems
 CFR Part 11 compliance
 Need to test all systems
 Need to test the testing systems!
 Drive for Agile Compliance
 New technologies let us develop new uses for existing systems,
devices and therapies
 To speed therapy, the rules are delayed not removed…
 How to be agile now and “compliant later”?

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Agile Today
Compliance Ready

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Best practices in
Software Validation & Testing

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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

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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.

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Overview of the Inflectra
Platform
What Inflectra offers and how the different parts fit together

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Bridging Between Agile and Compliance
Support for Regulated Processes Modern, Agile Processes
• Baselining
• Risk Management
• Electronic Signatures
• Data Privacy
• Compliance
• Workflow
• Requirements Mgt
• On-Premise
• CI / CD
• Scrum
• Kanban
• Scaled Agile
• DevOps
• Distributed Teams
• Remote Working
• Cloud-Based

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Compliancewith International Standards
EudraLex
Volume4
PartI&II
GuidanceonData
Integrity

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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

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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

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SpiraPlan Compliance Features
How we can help you streamline and automate your testing and
compliance.

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Regulated Industries - Automating
Compliance
End-to-end
traceability out
of the box
Data Privacy,
Security
baked in
Generate
Documentation
from data
Workflows &
Electronic
Signatures
Integration across
the software
value chain

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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

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Requirements Management
Requirements management with end-to-end traceability

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Requirements & Test Validation

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Requirements Test Traceability

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Traceability To Other Artifacts
 End to end traceability

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Integrated Risk Management
Manage your hardware and software risks with full traceability

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Document Management
Complete integrated document management system with
versioning, check-in/out and approval workflows.

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Workflow & Electronic Signatures

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Source Code Management
For software medical systems, traceability to the code
&

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Defect and Incident Tracking
Integrated defect tracking to track issues and corrections

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Audit Logging & Trail

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Controlled / Secure Access

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Federated Security with OAUTH and LDAP
• LDAP / Active Directory for On-Premise Customers
• OAUTH / ADFS for Cloud Customers

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Agile When You Need It…

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Resources to Help
How we can help you streamline and automate your testing and
compliance.

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Validation Resources
 Inflectra can supply a standard validation package for Spira
 Resources available for configuring Spira ‘in-place’
 HIPAA - https://www.inflectra.com/Ideas/Whitepaper/SpiraTeam-
HIPAA-Compliance-Checklist.aspx
 21 CFR Part 11 - https://www.inflectra.com/Ideas/Whitepaper/FDA-
Validation-and-Testing-with-21-CFR-Part-11.aspx
 GAMP moving from CSV to CSA -
https://www.inflectra.com/Ideas/Entry/preparing-gamp-computer-
software-assurance-csa-1434.aspx
 Cloud platform supports ability to lock “version”

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Validation Partners

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Application Demo