Dehradun Call Girls 8854095900 Call Girl in Dehradun Uttrakhand
Agile in Medical Software Development
1. O R T H O G O N A L
orthogonal.io
A G I L E I N A Q M S
What Medical Device Companies Need to Know
2. PRESENTATION AGENDA
orthogonal.ioAgile in a QMS2
Background
Agile Introduction
Agile for Medical Devices
How to be Agile in a QMS
Automation
How to be Agile in a QMS (for Non Developers)
Agile Implementation Mistakes
Resources
3. I N T R O D U C T I O N
Background on Bernhard and Orthogonal
orthogonal.ioAgile in a QMS3
4. ABOUT ME
4 Agile in a QMS orthogonal.io
Bernhard Kappe
CHIEF EXECUTIVE OFFICER, ORTHOGONAL
Bernhard is an expert in lean innovation and the
application of agile methods in regulated
industries. He is the author of the eBook Agile in
an FDA Regulated Environment and a frequent
conference speaker on wireless medical devices
and mHealth. He works with Orthogonal clients
on connected care strategy and at the application
of lean and agile methods.
10. ITERATIVE METHODS
Fast Feedback Loops to Reduce Uncertainty and
Efficiently Manage Change:
• OODA Loops
• Shewhart/Deming Cycles (PDCA)
• Six Sigma (DMAIC)
• Toyota Production System
• Lean Manufacturing
• Lean Startup
• Lean UX
orthogonal.ioAgile in a QMS10
11. AGILE
APPROACH
orthogonal.ioAgile in a QMS11
• Break functionality into the smallest units of customer value: the user
story.
• Organize the stories into a prioritized list called a backlog
• Organize development efforts into short (one to two week0 efforts called
iterations or sprints.
• The goal of each iteration: Demonstrate working software
• Take feedback and improve the process through retrospectives and
the software through refactoring.
• Self Organizing Teams
12. AGILE ITERATIONS
12
• Story Baking – Detailed specification of user stories, including acceptance criteria and ties to FURPS+.
• Story Points – Unit of estimation measuring complexity and size.
• Iteration Planning Meeting – a negotiation between the team and the product owner about what the team will do during the next
Iteration. The product owner and all team members agree on a set of Iteration goals, which are used to determine which product
backlog items to commit from the uncommitted backlog to the Iteration. Often new backlog items are defined during the meeting.
• Daily Standup Meeting - a 10-minute daily meeting for the team
• Pair Programming – two programmers work together on one user story.
• Test Driven Development (TDD) – repetition of a very short development cycle: first the developer writes a failing automated test case
that defines a desired improvement or new function, then produces code to pass that test and finally refactors the new code to
acceptable standards.
• Continuous Integration – code is checked into a continuous integration environment/build server, which runs automated tests (unit,
integration, static and dynamic analysis, etc.)
• Demo/Design Review - On a per iteration basis, functional software is reviewed by stakeholders, including source code review
• Retrospective - what went well and what to improve in the next Iteration.
15. A G I L E F O R
M E D I C A L
D E V I C E S
Why we need Agile and why it’s taken so long to adopt it
orthogonal.ioAgile in a QMS15
16. CHANGE AND UNCERTAINTY
• New Product Development
• Complex Systems
• System Interdependencies
• More Users
• Technology Changes
• Market Changes
• Regulatory Changes
orthogonal.ioAgile in a QMS16
17. orthogonal.ioAgile in a QMS17
MEDICAL DEVICE
CHALLENGES
The Target
Business Value/
Real-World
Outcomes
Patient Safety
Process
Efficiency
Regulatory
Compliance
18. BARRIERS TO AGILE
• Agile evolved in software, and Medical Devices used to not have much
software.
• Regulations, standards and guidance documents (CFR 21 Part 820, ISO
13485, IEC 62304) were mostly defined before agile, and are written in a
waterfall way.
• Medical Device regulations and standards have additional requirements
(risk management, design controls, verification and validation) that add
complexity to Agile.
orthogonal.ioAgile in a QMS18
19. THE FDA DESCRIBES RATHER THAN
PRESCRIBES
“The quality system requirements do not dictate the types of design process that a manufacturer must use.
Manufacturers should use processes best suited to their needs. However, whatever the processes may be,
it is important that the design controls are applied in an appropriate manner.”
FDA Design Control Guidance for Medical Device Manufacturers, p. 8
“Based on the intended use and the safety risk associated with the software to be developed, the software
developer should determine the specific approach, the combination of techniques to be used, and the level
of effort to be applied. While this guidance does not recommend any specific life cycle model or any
specific technique or method, it does recommend that software validation and verification activities be
conducted throughout the entire software life cycle.”
General Principles of Software Validation (GPSV), p. 1
orthogonal.ioAgile in a QMS19
20. RESOURCES: AAMI TIR45:2012
• Provides recommendations for complying
with international standards and FDA
guidance documents when using agile
practices to develop medical device
software.
• Agile brings value to medical device
software: continuous focus on safety, risk
management and control, impact analyses,
. . .
• Designs coherent (locally constant) and
highly cohesive (vs. tightly coupled)
• Recognized as a standard by the FDA in
2013
20
21. H O W T O B E
A G I L E I N A Q M S
Mapping Agile to IEC 62304 and CFR 21 Part 820
orthogonal.ioAgile in a QMS21
22. APPLYING AGILE UNDER THE
QSR
• Mapping agile (TIR 45) to IEC 62304
• Layering in: Risk Analysis, Design review, etc
• Verification Driven Development
Testing Automation
22
23. IEC 62304: MEDICAL DEVICE
SOFTWARE LIFECYCLE
PROCESSES
23
8. Software Configuration Management
9. Software Problem Resolution
7. Software Risk Management
5. Software Development Process
5.2 SW
Requirements
Analysis
5.3 SW
Architectural
Design
5.4 SW
Detailed
Design
5.7 SW
System
Testing
5.8 SW
Release
5.1 SW
Development
Planning
5.5 SW Unit
Implement.
& Verification
5.6 SW
Integration &
Integration
Testing
26. V-MODEL: BENT WATERFALL OR
AGILE?
orthogonal.ioAgile in a QMS26
User Requirements
System
Requirements
Specification
Software Detailed
Design
User Acceptance
Testing
System &
Integration
Testing
Unit Testing
Quality Assurance / Risk Control • Relationship between
artifacts are time-
independent
• Finish to finish parallelism
(vs. start to finish)
• Design Inputs ↔ Design
Outputs
• Synchronize Approvals
27. BEHAVIOR DRIVEN DEVELOPMENT
(BDD)
orthogonal.ioAgile in a QMS27
“Behavior-driven development is an
“outside-in” methodology. It starts at
the outside by identifying business
outcomes, and then drills down into
the feature set that will achieve those
outcomes. Each feature is captured as
a “story”, which defines the scope of
the feature along with its acceptance
criteria.”
• —Dan North
Title (one line describing the story)
Narrative:
As a [role]
I want [feature]
So that [benefit]
Acceptance Criteria: (presented as Scenarios)
Scenario 1: Title
Given [context]
And [some more context]...
When [event]
Then [outcome]
And [another outcome]...
Scenario 2: ...
28. VERIFICATION DRIVEN AGILE
orthogonal.ioAgile in a QMS28
Verification Test
• Avoids different interpretations of
requirements and specification that are
typical in waterfall development
• This avoids “verification hell” that can double
the length and cost of a project.
• Allows for continued feedback from end
users on working software – further reducing
risk
29. R I S K
M A N A G E M E N T
I N A G I L E
It’s Iterative
orthogonal.ioAgile in a QMS29
30. THE ITERATIVE NATURE OF
RISK
orthogonal.ioAgile in a QMS30
“Risk can be introduced throughout the product lifecycle, and risks that
become apparent at one point in the life-cycle can be managed by
action taken at a completely different point in the life cycle.”
ISO 14971: 2007 Medical devices -- Application of
risk management to medical devices
31. orthogonal.ioAgile in a QMS31
ITERATIVE RISK MANAGEMENT
• Iterative Risk Analysis Takes inputs from and
provides outputs to Human Factors and
Development
• Risk Mitigations are reflected in new stories.
• Risk Mitigations are verified and validated
• The Iterative Risk Management cadence can
be different than the development cadence
32. HUMAN FACTORS
ENGINEERING
orthogonal.ioAgile in a QMS32
• Lean and agile cadence ships insights and/or UI each iteration
• User experience architecture maps and assesses human
interaction models and requirements
• Usability studies conducted with real users to identify and assess
the effectiveness of vital system interactions
• Interactive prototypes to simulate interactive functions of the
software
• User interface design of software interface using color, animation,
text and graphics
• Result:
– User Engagement
– Real-World Outcomes
33. A U T O M A T I O N
The key to maintaining quality at speed
orthogonal.ioAgile in a QMS33
34. TDD+ BDD + TESTING AUTOMATION
34
From this:
… to this
35. TESTING AUTOMATION
• Full Code Coverage: Unit, Integration, Acceptance Testing built into continuous
integration environment.
• White-box and black-box testing for all elements of the stack,
from hardware to firmware to web services
• Result:
– Maintain Velocity on Larger, More Complex Projects
– Faster Parallel Development of Hardware and Software
– Faster, More Efficient Maintenance
orthogonal.ioAgile in a QMS35
39. H O W T O B E
A G I L E I N A Q M S
( F O R N O N -
D E V E L O P E R S )
A selection of connected care solutions Orthogonal has
developed for the medical industry.
orthogonal.ioAgile in a QMS39
41. orthogonal.ioAgile in a QMS41
Agile development is
wasted If none of the
related processes can
iteratively provide and
receive input.
Risk
Managment
Human
Factors
Verification &
Validation
Post Market
Surveillance
Product
Managment
Document
Managment
43. PUTTING IT ALL TOGETHER
orthogonal.ioAgile in a QMS43
Business Value/
Real-World
Outcomes
Patient Safety
Process
Efficiency
Regulatory
Compliance
Better usability,
adherence/compliance = Improved
Engagement and Outcomes
Iterative Risk Management = Safer
Products and Reduced
Regulatory Risk
Faster Development
Streamlined Maintenance and
Manufacturing
Platform Development/Reusability
44. A G I L E
I M P L E M E N TAT I O N
M I S T A K E S
A selection of connected care solutions Orthogonal has
developed for the medical industry.
orthogonal.ioAgile in a QMS44
45. orthogonal.ioCompany Overview45
Area Finding (Gap) Best Practice Consequences of Gap Recommended Approach Dependencies
Quality Management Development Methodology
and Quality Management
System (QMS) are Tightly
Coupled
Loose Coupling of Quality
Management and Development
Approach.
Changes in development methodology as
needed by individual projects may result in
changes and re-approvals of parts of the
QMS which takes time and consumes
significant organizational resources
Allow for different development methodologies by
stating in QMS that any methodology based on a
standard and that meets relevant regulations is
allowed as long as it is approved by Quality.
Consider templated approach at SDP level.
Approvers of QMS (Executive
management, Quality,
Regulatory)
Risk Management Risk Management is not
iterative and integrated into
agile process
QMS states that Risk Management
Plan determines how risk control is
performed throughout the product
lifecycle.
Risk Management that is not iterative and
integrated into agile process may result in an
"Agile Falls" lifecycle where risk "in-stream"
risk analysis and mitigation suffers and risk
management activities become a bottleneck
for other project activities to continue
QMS does not specify risk management
methodology, only that risk control activities will be
performed throughout the project lifecycle as
required by relevant regulations. Risk
Management Plan outlines risk control activities
and their rationales on a per project basis.
QMS Risk Management
Process.
Verification and Validation Verification and Validation
(VnV) is not iterative and
integrated into agile process
QMS states that Validation Plan
determines how VnV is performed
throughout the product lifecycle
VnV that is not iterative and integrated into
agile process may result in an "Agile Falls"
lifecycle where verification testing fails to
indicate when an issue appears and VnV
activities become a bottleneck for other
project activities to continue.
QMS includes a VnV process definition that is
iterative and can be integrated into agile
processes.
QMS Verification And
Validation Process.
Requirements Management Requirements PRDs do not
incorporate Agile User
Stories
Include "story points" in User Stories
as user requirements
User requirements may miss important user
requirements
Include "story points" in User Stories as user
requirements. Also consider using Human Factors
Engineering and Stakeholder (e.g. clinician and
patient) flow analyses as a way of logically
grouping User Stories.
QMS Requirements
Management Process
Requirements Management Inadequate Software Tools
for Requirements
Management and
Traceability
Analyze and determine which tools
for Requirements Management and
Traceability would best fit the
organization.
Poorly specified requirements, inadequate
traceability; inability to analyze logically
categorize requirements
Follow recommendation for which tools to use for
Requirements Management and Traceability that
would best fit the organization
QMS
Testing Automation No unit or integration tests Implement a "test first" approach to
Unit Tests when specifying low level
requirements (i.e. how would this
requirement be tested?).
Poorly specified and tested requirements. Automate unit and integration testing in a
Continuous Integration Environment
QMS Test Plan, Tools
Validation
Testing Automation No Continuous Integration
Environment
Specify interface requirements and
sub-system integration tests during
system development.
Poorly specified and tested requirements. Automate Continuous Integration Environment;
justify when able to do so.
QMS Test Plan, Tools
Validation
Testing Automation No Acceptance tests Specify user acceptance tests when
constructing User Requirements.
Poorly specified and tested requirements. Automate acceptance testing (as reasonably
possible)
QMS Test Plan, Tools
Validation, Continuous
Integration Environment
Acceptance test automation
46. #1: TIGHT COUPLING
Finding: Development Methodology and Quality Management System (QMS) are Tightly Coupled
Consequences: Constraints on Implementing Agile. Changes in development methodology as needed by
individual projects may result in changes and re-approvals of parts of the QMS which takes time and
consumes significant organizational resources.
Best Practice: Loose Coupling of Quality Management and Development Approach.
Recommended Approach: Allow for different development methodologies by stating in QMS that any
methodology based on a standard and that meets relevant regulations is allowed as long as it is approved
by Quality. Consider templated approach at SDP level.
Dependencies: Approvers of QMS (Executive management, Quality, Regulatory)
orthogonal.ioAgile in a QMS46
47. #2: WATERFALL RISK MANAGEMENT
Finding: Risk Management is not iterative and integrated into agile process
Consequences: Risk Management that is not iterative and integrated into agile process may result in an "Agile
Falls" lifecycle where risk "in-stream" risk analysis and mitigation suffers and risk management activities become a
bottleneck for other project activities to continue
Best Practice: QMS states that Risk Management Plan determines how risk control is performed throughout the
product lifecycle.
Recommended Approach: QMS does not specify risk management methodology, only that risk control activities
will be performed throughout the project lifecycle as required by relevant regulations. Risk Management Plan
outlines risk control activities and their rationales on a per project basis.
Dependencies: QMS Risk Management Process.
orthogonal.ioAgile in a QMS47
48. #3: V&V NOT INTEGRATED
Finding: Verification and Validation (V&V) is not iterative and integrated into agile process
Consequences: V&V that is not iterative and integrated into agile process may result in an "Agile Falls"
lifecycle where verification testing fails to indicate when an issue appears and V&V activities become a
bottleneck for other project activities to continue.
Best Practice: QMS states that Validation Plan determines how V&V is performed throughout the product
lifecycle.
Recommended Approach: QMS includes a V&V process definition that is iterative and can be integrated
into agile processes.
Dependencies: QMS Verification And Validation Process
orthogonal.ioAgile in a QMS48
49. #4: NO USER STORIES IN THE
PRD
Finding: Product Requirement Documents do not incorporate Agile User Stories
Consequences: Requirements may miss important user requirements, and require additional translation to
agile-usable requirements
Best Practice: Include story definitions in User Stories as user requirements
Recommended Approach: Include story definitions in User Stories as user requirements. Also consider
using Human Factors Engineering and Stakeholder (e.g. clinician and patient) flow analyses as a way of
logically grouping User Stories.
Dependencies: QMS Requirements Management Process
orthogonal.ioAgile in a QMS49
50. #5: NO AGILE RM TOOLS
Finding: Inadequate Software Tools for Requirements Management and Traceability
Consequences: Poorly specified requirements, inadequate traceability; inability to analyze logically
categorize requirements, lots of extra work.
Best Practice: Analyze and determine which tools for Requirements Management and Traceability would
best fit the organization.
Recommended Approach: Follow recommendation for which tools to use for Requirements Management
and Traceability that would best fit the organization
Dependencies: QMS, Tools Validation
orthogonal.ioAgile in a QMS50
51. #6: NO TDD OR BDD
Finding: No or insufficient unit, integration and acceptance test coverage.
Consequences: Poorly specified and tested requirements. Bugs, more laborious maintenance
Best Practice: Implement a "test first" approach to Unit Tests, Integration Tests and Acceptance tests
when specifying requirements (i.e. how would this requirement be tested?).
Recommended Approach: TDD and BDD, Automate unit, integration and acceptance testing in a
Continuous Integration Environment
Dependencies: QMS Test Plan, Tools Validation
orthogonal.ioAgile in a QMS51
52. #7: NO PAIRING
Finding: No Developer Pairing
Consequences: Slower development, greater dependency on individual developers (lower “bus number”),
no built-in design review, less ability to scale projects up and down, higher training costs
Best Practice: Implement Promiscuous Pairing.
Recommended Approach: Training and Mentoring by developers experienced with pairing.
Dependencies: Developers who can pair
orthogonal.ioAgile in a QMS52
53. R E S O U R C E S
A selection of connected care solutions Orthogonal has
developed for the medical industry.
orthogonal.ioAgile in a QMS53
54. RESOURCES: AAMI TIR45:2012
• Provides recommendations for complying
with international standards and FDA
guidance documents when using agile
practices to develop medical device
software.
• Agile brings value to medical device
software: continuous focus on safety, risk
management and control, impact analyses,
. . .
• Designs coherent (locally constant) and
highly cohesive (vs. tightly coupled)
• Recognized as a standard by the FDA in
2013
54
55. RESOURCES: ORTHOGONAL
EBOOK
• Addresses the shortcomings of waterfall
development specifically in regulatory
environments.
• How agile development meets the
safety, reliability and regulatory needs of
the medical device and diagnostics
industry.
• How agile development can help ensure
delivery of successful software.
55
56. Q U E S T I O N S ?
Bernhard Kappe
bkappe@orthogonal.io
orthogonal.ioAgile in a QMS56
We build everything except the devices and the firmware. Connectivity, mobile, web, cloud, integration to midleware for clinical systems.
Look at traditional waterfall development process – how we used to do everything, including software. This works great when problems and solutions are well known.
But if not, if you have changes – it gets expensive quickly, because you have to go all the way back and make changes to everything else.
Change is inevitable, and there are many unknown things.
There’s another set of approaches, which is based on fast feedback loops to address change.
All based on a build-measure-learn loop and making adjustments.
From military Observe, Orient, Decide and Act. – if your OODA loop is faster, you increase your chances of winning.
All are about Feedback
Agile applies this to software development.
Agile does not attempt to lock down all requirements up front. It assumes that the requirements and design will evolve and change as more is learned and discovered during the process.
It works by breaking projects down into user stories - little bits of user functionality that create value for the user - prioritizing them, continuously delivering them in short one to three week cycles called iterations, and getting feedback on the working software to incorporate back into the development process.
This is a more complex system, with more moving parts, and more things that can go wrong: hardware, software stack, integrations, data and algorithms. There are a lot of dependencies there.
Integrations are points of failure
* Data loss, distributed systems, transmission
Latency can be a problem - example – neurostimulation implant used for accelerating stroke rehab. Button pressed by clinician. There was unanticipated lag in the wireless transmission. Had to do a whole new animal trial to see if the lag time was clinically important.
If you have connected systems, you have security risks and privacy risks.
HIPAA compliance includes security and privacy considerations. You also need to think about business associates agreements. This also includes any analytics. Google analytics, others not. Need this.
FDA has cybersecurity guidance documents – others have talked about this at the conference in much more detail. They’ve put in place a lab for fuzz testing, will be a greater point of emphasis
If some of what you need to do involves apps in app stores – be careful which ones you put them in, because what comes out may not be what you put in. One of our clients asked us to run a test on this for android app stores. We built and submitted a very small app in such a way that it was easy to reverse engineer what the app stores did to them. I can’t really name names here, but in some cases it was harmless. In others they put a lot of extra things into the apps.
Complex systems with lots of moving parts. Devices, sensors, diagnostics, mobile, back end systems, integrations. Some of these are changing quickly.
Users are tricky.
If you remember that we’re all wireless that adds more complexity – there are more users of the systems than you think – potentially clinicians, technicians, patients, caregivers, etc.
For patients – don’t have training, depending on patients, very varied abilities and knowledge. Children, elderly, etc.
Real world issues.
Not just use error, but usability important (EU, need to take that into consideration.)
Real World Issues are what’s important here.
Do this in a complex, rapidly changing enviroment
FDA does not dictate process. It describes but does not prescribe.
One of the biggest things that trips people up is this old graph from the 1970’s that’s still in the FDA guidance.
FDA does not dictate process. It describes but does not prescribe.
Risk management core to the process
Collaborative with our clients – risk evaluation
Responsive to inputs
Safer!
tw
Underlying mobile and cloud platforms change in weeks and months. Maintenance using manual processes can’t keep up.
Automated V&V and full traceability lets you run your software on the new platform, see what breaks, fix it, test it, document it, and be ready in days, not months.
You’ll be ready to ship the day the new OS goes out of beta, not 5 months afterwards.
Tooling to manage the process, lightweight, manage agile requirements, traceability, hazard analysis, and documentation
How do we build successful connected care products? By making complex systems simple and elegant. Our process is designed from the ground up to address complexity, uncertainty and change. Here's how we help you accelerate the development of successful products:
DESIGN
Simplifying complexity starts with a deep understanding of unmet human needs. These insights drive design solutions we iteratively prototype and test, and result in artifacts that clearly communicate to agile developers so they can efficiently realize the design.
TECHNOLOGY
We've done this before. That means we understand devices, wireless and bluetooth protocols, cloud computing and clinical systems and how they interact. That let's us think ahead and apply a systems engineering approach to minimize surprises and technical risk.
AGILITY + QUALITY
Our quality processes integrate risk management, verification and validation. By eliminating the waste inherent in waterfall processes we accelerate development while improving quality. Our processes are in line with ISO 13485 and IEC 62304 standards and AAMI TIR:45.
TESTING AUTOMATION
Testing automation is core to managing complexity and quality at speed. For us that means automated system-level verification and validation testing, including black-box and white-box testing of hardware, software and interfaces. This enables accelerated development and maintenance.
How do we build successful connected care products? By making complex systems simple and elegant. Our process is designed from the ground up to address complexity, uncertainty and change. Here's how we help you accelerate the development of successful products:
DESIGN
Simplifying complexity starts with a deep understanding of unmet human needs. These insights drive design solutions we iteratively prototype and test, and result in artifacts that clearly communicate to agile developers so they can efficiently realize the design.
TECHNOLOGY
We've done this before. That means we understand devices, wireless and bluetooth protocols, cloud computing and clinical systems and how they interact. That let's us think ahead and apply a systems engineering approach to minimize surprises and technical risk.
AGILITY + QUALITY
Our quality processes integrate risk management, verification and validation. By eliminating the waste inherent in waterfall processes we accelerate development while improving quality. Our processes are in line with ISO 13485 and IEC 62304 standards and AAMI TIR:45.
TESTING AUTOMATION
Testing automation is core to managing complexity and quality at speed. For us that means automated system-level verification and validation testing, including black-box and white-box testing of hardware, software and interfaces. This enables accelerated development and maintenance.
Underlying mobile and cloud platforms change in weeks and months. Maintenance using manual processes can’t keep up.
Automated V&V and full traceability lets you run your software on the new platform, see what breaks, fix it, test it, document it, and be ready in days, not months.
You’ll be ready to ship the day the new OS goes out of beta, not 5 months afterwards.
Underlying mobile and cloud platforms change in weeks and months. Maintenance using manual processes can’t keep up.
Automated V&V and full traceability lets you run your software on the new platform, see what breaks, fix it, test it, document it, and be ready in days, not months.
You’ll be ready to ship the day the new OS goes out of beta, not 5 months afterwards.
Underlying mobile and cloud platforms change in weeks and months. Maintenance using manual processes can’t keep up.
Automated V&V and full traceability lets you run your software on the new platform, see what breaks, fix it, test it, document it, and be ready in days, not months.
You’ll be ready to ship the day the new OS goes out of beta, not 5 months afterwards.
Underlying mobile and cloud platforms change in weeks and months. Maintenance using manual processes can’t keep up.
Automated V&V and full traceability lets you run your software on the new platform, see what breaks, fix it, test it, document it, and be ready in days, not months.
You’ll be ready to ship the day the new OS goes out of beta, not 5 months afterwards.
Underlying mobile and cloud platforms change in weeks and months. Maintenance using manual processes can’t keep up.
Automated V&V and full traceability lets you run your software on the new platform, see what breaks, fix it, test it, document it, and be ready in days, not months.
You’ll be ready to ship the day the new OS goes out of beta, not 5 months afterwards.
Underlying mobile and cloud platforms change in weeks and months. Maintenance using manual processes can’t keep up.
Automated V&V and full traceability lets you run your software on the new platform, see what breaks, fix it, test it, document it, and be ready in days, not months.
You’ll be ready to ship the day the new OS goes out of beta, not 5 months afterwards.
Underlying mobile and cloud platforms change in weeks and months. Maintenance using manual processes can’t keep up.
Automated V&V and full traceability lets you run your software on the new platform, see what breaks, fix it, test it, document it, and be ready in days, not months.
You’ll be ready to ship the day the new OS goes out of beta, not 5 months afterwards.