pay now or later: creating solid system application user requirements
TRANSCRIPT
Premier Laboratory Informatics ExpertsStrategic Planning Implementation Validation
Pay Now or Later: Creating Solid System
Application User Requirements
Katherine H. Temple
Laboratory Informatics Consultant
© 2017 CSols, Inc.
What is a URS?
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User Requirement
Specification:
Just another boring IT
document?
© 2017 CSols, Inc.
What is a URS?
3
User Requirement
Specification:
Just another boring IT
document?
© 2017 CSols, Inc.
What is a URS?
4
A vital piece of the
informatics solution puzzle
© 2017 CSols, Inc.
User Requirements Specification
Protects the investment in the system
Keeps focus on
functionality that is
valuable to the
business
Keeps vendor focused
Proves agreement on
expectations between
customer and vendor
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© 2017 CSols, Inc.
User Requirements Specification
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Shows “fit for purpose”
Must first define intention
before proving system fulfills
intended use
Will be vital during validation
Defines intended purpose for regulatory
requirements:
© 2017 CSols, Inc.
Set Yourself Up for Success
Clarify the purpose and scope of the
document with team members
Specifies what the user expects the software
to be able to do
Does not define how the software will execute
the functionality
Keep explanations simple
Always keep the floor open for questions
Remind everyone there are no stupid
questions7
?
© 2017 CSols, Inc.
Overcoming Challenges: Resources
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© 2017 CSols, Inc.
Overcoming Challenges: Resources
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Select the appropriate SMEs
Just like you wouldn’t play a football
game with 11 quarter backs, you don’t
want only managers and team leads
writing the URS
© 2017 CSols, Inc.
Overcoming Challenges: Resources
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LIMS impacts
many areas,
make sure all
areas are
represented
A LIMS is like
intertwining roots of
a forest in how it
touches all parts of
the business
© 2017 CSols, Inc.
Overcoming Challenges: Resources
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Get ‘em while they’re hot!
Take advantage of any momentum
from project kickoff and any
excitement about upcoming
changes
Engage resources who are excited
about the project right away and
take advantage of their willingness
to contribute
© 2017 CSols, Inc.
Overcoming Challenges: Buy-in
Management support
Make the project a priority
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© 2017 CSols, Inc.
Overcoming Challenges: Buy-in
Management support
Make the project a priority
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Generate excitement and buzz
Why will a solid URS make the
project great?
What’s in it for me?
Recruit champions
Management
Non-management influencers
© 2017 CSols, Inc.
Focus on the Business Needs
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© 2017 CSols, Inc.
Focus on the Business Needs
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© 2017 CSols, Inc.
Focus on the Business Needs
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Clinic a l
Manufac turing
Clinic a l Study
ManagementGLP LabDisc overyCommerc ia l
Manufac turingDevelopment
SDMS
Enterprise Resource Planning (severa l years down the road)
MES
Clinical Trial
Management
System
Clinical
Single Source
of Truth (SSOT)
LIMS
Asset Management System (Blue Mounta in a lready in p lac e in some a reas)
QC LIMS (one system preferred for GLP and
QC (MG has limited IT resourc es for
ma inta ining and administering multip le
systems) but it is more important tha t the
systems a re fit for purpose
Accounting System (most likely Deltek, might la ter be inc orpora ted into ERP)
MES
ELN
Enterprise/ electronic Content Management System (likely c oming in 2016 a t the same time as LMS)
Learning Management System (likely c oming in 2016 a t the same time as EDCS or ECMS)
Other clinical
automation
Quality/ Regulatory Management System
Commerc ia l p roduc tion in ~2019
© 2017 CSols, Inc.
Reviewing the URS Document
Much easier to correct requirements at this
stage
Reviewers should be a different group of
individuals, but with similar expertise to the URS
authors
Each requirement should be testable and
specific
Include quantities
Avoid generalizations like “fast” or “simple”
Avoid jargon, acronyms, and ambiguous terms
Prioritize requirements 17
© 2017 CSols, Inc.
More than just a document
A solid process leads to a well-written
URS
Improves communication
Establishes a foundation of teamwork
Improves understanding of the overall
process
Empowers SMEs
Builds support for the project
Provides groundwork for future improvements
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© 2017 CSols, Inc.
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Katherine Temple
Informatics Consultant
www.csolsinc.com