can you be agile and compliant?
TRANSCRIPT
©2016 IDBS
Can You BeAgile and Compliant?Agile on the Beach 2016
Stuart Ward
©2016 IDBS
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Moving a Business from Waterfall to Agile
©2016 IDBS
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Are the Consultants Right?
©2016 IDBS
Who are IDBS?
©2016 IDBS
IDBS today Our core expertise is software
solutions for data management• One of the best known brand
names - the gold standard in biological data management• High quality software backed
up by first class professional services • 250+ employees based in
Europe and USA • Track record of successfully
supplying enterprise-wide software solutions• Industry recognised
©2016 IDBS
IDBS Products
Fully integrates with Microsoft® Excelfor intuitive curve fitting and powerful statistical analysis to visualize, interpret and present scientific data.Enterprise data management and
analytics solutions that optimize processes for low to ultra high volume data, and improve efficiency locally and globally.
The flexible, extensible and adaptable ELN that captures, analyzes, searches and reports experimental data in a fully compliant environment.
E-WorkBook
ActivityBase Suite
XLfit
QuantrixFinancial modeling software for forecasting, budgeting and planning that replaces spreadsheets for enhanced business performance and more timely insights.
©2016 IDBS
ENGINEERING ENERGY FOOD & BEVERAGE
CHEMICALS AGRICULTURAL SCIENCES
CONSUMER GOODS
PHARMA & BIOTECH
HEALTHCARE
Research Development
Research Development
Research Development
Research Development
Research Development
Research Development
Research Development
Research Development
Biological sciences
Translational sciences
Pharmacology & preclinical sciences
High volume testing
Chemical sciences
Analytical sciences
Data & financial modeling
Different verticals – similar science
©2016 IDBS
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E-WorkBook Used in ‘Compliant’ Domains USA• FDA predicate rules for cGMP and GLP• 21 CFR Part 11 Electronic Records; Electronic Signatures
Japan• ERES (Using electromagnetic records and electronic signatures for application for approval or licensing of drugs)
Europe• EMA EU Annex 11 (GMP), Chapter 4 Computerised Systems• OECD GLP
©2016 IDBS
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IDBS QMS
QMS established over many years
Successfully audited by customers and certification bodies
©2016 IDBS
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Move to Agile
©2016 IDBS
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Existing Waterfall Approach
Positives Negatives Robust process• Successfully audited
Able to define an endpoint• Important for Marketing
Able to define scope
Bloated process• Large amounts of documentation• Excessive approvals
Scope needs to be defined upfront Long projects Projects not delivered on time Product Management, Development
and Test siloed Software releases are chaotic
©2016 IDBS
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IDBS’ Agile Requirements
Improve quality Releases delivered on time Being more nimble /
accepting change Smaller teams taking
ownership Less paperwork Software meets regulatory
requirements and traceability
Successful audits
©2016 IDBS
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Challenges of Moving to Agile
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January 2015…
20172015 2016
Initiatives + Epics
JIRA Team Backlogs (Epics + Stories)
Rele
ase
Trai
nPo
rtfol
ioPr
ogra
mm
e
©2016 IDBS
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Organisation
Product (Marketin
g) Manager
• Commercial Strategy
• Marketing
Product Owner
• One for each Feature Team
• Creating Stories• Backlog Management
UX Designer • All Things UX
©2016 IDBS
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Feature Teams
DailyStand Up
Sprint Cycle2 Weeks
Story
©2016 IDBS
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The Story – Basis for Traceability
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The Story – Basis for Traceability
Conditions of Satisfaction
Risk Based Testing
Link to Code and Review
Link to Tests
Definition of Done
Product Owner Approval
©2016 IDBS
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Easy Reporting
©2016 IDBS
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Feature Teams
Stickerbook
Spreadsheet
Search
Performance
Platform
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Feature Teams
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The Big Picture
Release Team
©2016 IDBS
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What’s Important for Agile Efficiency?
Communication Automation
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Agile is Full On
Need to include other activities…
©2016 IDBS
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Has Agile Improved Software Delivery at IDBS?
Improved quality Releases delivered on time• Predictable for customers
Being more nimble / accepting change
Smaller teams taking ownership
Less paperwork Software meets regulatory
requirements and traceability Successful audits
©2016 IDBS
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What Next?
Expanding the use of Agile through the IDBS business• Help Desk•Global Field Operations
Using the SAME tools to enable easy information sharing
©2016 IDBS
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Thank you!
©2016 IDBS
28For further information view our website: www.idbs.com or email: [email protected]
IDBS Community
LinkedIn: IDBS
SlideShare: IDBSTwitter: @IDBSsoftware
blog.idbs.com Google+: IDBSsoftware
www.idbs.com/careers
©2016 IDBS
Can You BeAgile and Compliant?Agile on the Beach 2016
Stuart Ward