The US medical device, pharmaceutical, and healthcare industries have stringent regulatory norms to protect patients' safety and privacy. They are under constant pressure to provide innovative solutions for improved personal care while staying compliant with the ever-evolving regulatory landscape. But how do you bridge the gap between agile development for innovation and audit readiness for compliance? In this session, Sundar Selvatharasu and Andy Spoone of Sierra Labs will share how they use Jira both for engineering innovation and as a quality management system for compliance with GXP, GDPR, and HIPAA.

1. Architecting Atlassian for
Healthcare and FDA Compliance
SUNDAR SELVATHARASU | CHIEF COMPLIANCE OFFICER | SIERRA LABS
ANDY SPOONE | CHIEF OPERATING OFFICER | SIERRA LABS

2. IMPLEMENT AGILE IN A
REGULATED FRAMEWORK AND
INTEGRATE WITH YOUR QMS

3. Agenda
Root of the challenge
Proven Methods
Tools & Configuration
Human Engineering
Living the outcome

4. Finding the root
Devops <> Compliance

5. DEVOPS
SAY
Unproven
Staking credibility
Risk > reward
QUALITY
COMPLIANCE
HEAR
Innovation
Speed 2 market
Launch & iterate

6. Quantify risk
Cost of failure
Launch when ‘ready’’
QUALITY
COMPLIANCE
SAY
DEVOPS
HEAR
Documents
Documents
Documents

7. WATERFALL IS
DISCIPLINED!
AGILE IS
FUNDAMENTAL!
Innovation
Speed 2 market
Launch & iterate
Quantify risk
Cost of failure
Launch when ‘ready’’
DEVOPS
QUALITY
COMPLIANCE

8. “Agility is the counterpart
of discipline….
discipline ingrains & strengthens,
agility releases and invents”
- Barry W. Boehm

9. Proven Methods
Getting your processes aligned

10. Waterfall or Agile
Good waterfall or Bad agile
Good waterfall or Good agile

11. Dev
QA
BA
Project Management (Buss.)
Project Management (Tech)
Buss. Testing UAT (PQ)
Operations
QUALITY COMPLIANCE

12. DEVOPS

13. DRIVERS

14. Waterfall
Requirements Gathering
Business Design
Technical Design
Systems Development
Unit Testing
Integration Testing
Acceptance Testing
(Release Complete)
Agile
(Limited Upfront Planning)
Release #1 (Val)
Iteration 1
Iteration 2
Iteration 3
Release #2 (Val)
Iteration 4
Iteration 5
Iteration 6
Release #3 (Val)
Iteration 7
Iteration 8
Iteration 9
(Release Complete)
Iteration #
Planning
Development
Continuous Integration
Unit Testing
Functional & Acceptance Testing

15. Fused Approved
Iteration n-1 Iteration n Iteration n+1
Planning Planning Planning
Project Inception Requirements Requirements Requirements
Analysis Analysis Analysis
Design Design Design
User Evaluation User Evaluation User Evaluation
Risk Identification Risk Identification Risk Identification
Write Test/
Develop
Write Test/
Develop
Write Test/
Develop
Demo Demo Demo
User Testing User Testing User Testing
Risk Evaluation Risk Evaluation Risk Evaluation
Acceptance Testing Acceptance Testing Acceptance Testing
Verification Testing Verification Testing Verification Testing Release
Retrospective Retrospective Retrospective

16. is this the best we
can do?
Milton Waddams
Initech

17. Tools and Configuration
What do you need in your toolbox to accomplish this?

18. Tools to Achieve Compliance
Electronic Signature
21 CFR part 11 compliant
management of electronic
source data.
CAPA
Manage CAPAs and risk in
same platform.
Traceability
Automate traceability
reports.
Publishing
Produce PDFs with company
branded templates.
Change Management
Enforce Standard
Operating Procedures
(SOPs).
Testing
Capture validation
requirements.

19. Features
E-Signature
Publisher
Testing
CAPA
Electronic Approval
Approve all items with unique id and
password for 21 CFR part 11 compliance.

20. Features
E-Signature
Publisher
Testing
CAPA
Automate Publishing
Publish PDFs based on company
templates.

21. Features
E-Signature
Publisher
Testing
CAPA
Validation Coverage
Integrated testing alongside
requirements, specifications, and
incidents.

22. Features
E-Signature
Publisher
Testing
CAPA
Continuous Improvement
Quality metrics recorded in same
system.

23. TRACEABILITY
Trace
Illustrate links between all
issue types.
Status
Get updated status for all
linked issues.

24. TRACEABILITY
Trace
Illustrate links between all
issue types.
Status
Quickly identify which issues
need your attention.

25. CHANGE MANAGEMENT
Workflows
Align workflows with Standard
Operating Procedures (SOPs)
Scripted Rules
Programmatically enforce
SOPs.
Unified Platform
Integrate your software and
hardware development life
cycles in same platform as
quality management system.

26. CHANGE MANAGEMENT
Scripted Rules
Programmatically enforce
SOPs.
Workflows
Align workflows with Standard
Operating Procedures (SOPs)
Unified Platform
Integrate your software and
hardware development life
cycles in same platform as
quality management system.

27. CHANGE MANAGEMENT
Unified Platform
Integrate your software and
hardware development life
cycles in same platform as
quality management system.
Workflows
Align workflows with Standard
Operating Procedures (SOPs)
Scripted Rules
Programmatically enforce
SOPs.

28. ON THE GO
Transition and Assign
Complete workflows on the
go in the iOS and Android
mobile applications.

30. HUMAN
ENGINEERING

32. Message your Future
Be Clear Include
Relate Overcommunicate

33. Data is
perceived

34. CULTURE
Perception Belief Behavior Culture

35. Living the outcome
Simplify
Unify the source of truth
Collaborate
Transparency is key
Predictable
Deliver your plan

36. q Quantify work needed to be compliant
q Modify Jira workflows to include compliance
checkpoints
q Align operation and validation teams
q Adopt add-ons in devops pipeline to
automate compliance
q Reduce redundant efforts across teams
q Reach out for support
NEXT STEPS - CHECKLIST

37. SUNDAR SELVATHARASU | CHIEF COMPLIANCE OFFICER | SIERRA LABS
ANDY SPOONE | CHIEF OPERATING OFFICER | SIERRA LABS