can you be agile and compliant?

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Can You BeAgile and Compliant?Agile on the Beach 2016

Stuart Ward

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Moving a Business from Waterfall to Agile

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Are the Consultants Right?

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Who are IDBS?

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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

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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.

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ENGINEERING ENERGY FOOD & BEVERAGE

CHEMICALS AGRICULTURAL SCIENCES

CONSUMER GOODS

PHARMA & BIOTECH

HEALTHCARE

Research Development








Biological sciences

Translational sciences

Pharmacology & preclinical sciences

High volume testing

Chemical sciences

Analytical sciences

Data & financial modeling

Different verticals – similar science

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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

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IDBS QMS

QMS established over many years

Successfully audited by customers and certification bodies

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Move to Agile

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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

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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

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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

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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

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Feature Teams

DailyStand Up

Sprint Cycle2 Weeks

Story

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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

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Easy Reporting

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Feature Teams

Stickerbook

Spreadsheet

Search

Performance

Platform

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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

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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

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28For further information view our website: www.idbs.com or email: [email protected]

IDBS Community

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