it strategy for life sciences david royle

IT Strategy

on a fit-for-purpose technology platform

designed for a contract life sciences

business

David Royle, Chief Information Officer, Envigo

© 2015 Envigo 1

[email protected]

mailto:[email protected]

Contents

InfrastructureEnabling foundation

ApplicationsThe way we do

business

ProjectsThe force for change

Support servicesThe face of IT

Systems complianceMeeting regulatory

guidelines

SummaryThe big picture

2

Summary - the big picture

© 2015 Envigo

IT strategyon a fit-for-purpose technology platform

designed for a contract life sciences business

3

Base your management decisions on a long-term philosophy,

even at the expense of short-term goals - Toyota

Vision – a life sciences technology platform

4

INFRASTRUCTURE

DATA CAPTURE

INFORMATION MANAGEMENT

BUSINESS INTELLIGENCE

CUSTOMER COLLABORATION

Enabling foundation

Core capability

Transformation

Insight

Innovation and value

Infrastructure – the enabling foundation

5

INFRASTRUCTURE

Build on a solid foundation to host the data, applications and information needs of the business

The cloud – “Somebody else's computer”


6

INFRASTRUCTURE

Consolidate to fewer data centres, standardise equipment, connect sites and host applications & services centrally

Consolidate to quality data centres and build with standard

equipment

Ensure the WAN is robust, performs and connects all sites to the

data centres

Move key services to data centres enable

fail-over & local site

survivability

Push voice, video, data & applications

on to the network

1 2 3 4

Data – the lifeblood of a scientific business

7

DATA CAPTURE

Data is captured, analysed and reported for research and manufacturing; its integrity is paramount!

The MHRA are actively inspecting Computerised Systems

with specific attention to Data Integrity – new guidelines

Data – the lifeblood of a scientific business

8

DATA CAPTURE

Inventory, assess risk, cost & benefits – then rationalise and standardise onto fewer applications

Build a detailed inventory of all the business applications

Assess risks, benefits, costs and strategic

value

Engage with operational

management and build a roadmap

Consolidate onto fewer,

quality applications

1 2 3 4

Information management – the way to do business

9


Managing the flow of information is the key to improving productivity, everyone in a business interacts with information

Powerful and highly configurable applications can make a massive difference to the way a business operates

Information management – the way to do business

10


Managing the flow of information is the key to improving productivity, everyone in the business interacts with information

Map out the business

processes end-to-end

Address the inefficient

manual tasks- paper forms,

Excel

Focus on Enterprise

Class applications.

Build the business case

Integrate applications

to reduce duplication -single source

of truth

1 2 3 4

Business intelligence – the way to win more business

11

BUSINESS INTELLIGENCE & INFORMATICS

Analyse business data from sales, to revenues in real-time

Build data relationships across scientific disciplines

Informatics give insight to data across applications and studies the ability to understand data at a level beyond an individual study

Business intelligence – the way to win more business

12


Use the information from applications to analyse business

metrics and scientific data using BI and informatics

Identify the key business metrics and the

scientific data relationships

Deploy tools that can pull this data in

real-time and visualise

Use this for decision

making and involve

customers

Transform the way you

forecast, plan, operate

and report

1 2 3 4

Customer collaboration – what sets you apart

13


Innovators like Uber, Airbnb disrupt the traditional approach without using current infrastructure, new platforms designed for existing customers

Customer collaboration – what sets you apart

14


Transform the way you collaborate with customers and innovate – make it something they can’t do without!

Innovate, disrupt and

create something

unique

Use examples of innovation already within your business

or sector

Start with “What are the pain points for customers?”

You have to think

differently to succeed

1 2 3 4

Unlocking the value stream

15

INFRASTRUCTURE

DATA CAPTURE




Enabling Foundation

Core Capability

Transformation

Insight

Innovation & value

How do you get there?

16

INFRASTRUCTURE

DATA CAPTURE




Enabling Foundation

Core Capability

Transformation

Insight

Innovation & value

17

01

Understand the current state

Agree principles for decision making02

Analyse and mitigate high risks03

Design a strategy using principles04

Develop a roadmap05

18

INFRASTRUCTURE

You are most likely already working on detailed infrastructure plans that build out data centres, network, compute and storage platforms

Much of the groundwork may already be there - focus on standardising the environment and ensuring it is fit-for-purpose, qualified and compliant


DATA CAPTURE

19

Work with the business to develop an application roadmap that reduces risk, standardises onto fewer systems and has strategic long term benefit

Develop business cases and focus on tangible benefits, portfolio management and strong governance

Prioritise these plans alongside

other company plans and

objectives

Analyse risks, mitigate and focus on benefits

20


Form a guiding coalition of senior business leaders reviewing plans for all programs and projects to gain buy-in and understanding

Select quality applications, use a robust RFP process

Think about which business processes to tackle first and what will bring the most benefit - to get the most from capital investment

Work with the business to develop a roadmap

21


Are you using standard data analysis tools that are pulling on the right information sources?

What are you trying to achieve? Are you working together and using the standard tools looking at the right metrics that mean something to the customer?

Develop guiding principles for decision making

22

This where you capture the real value that can make you unique in the market.

Innovation is key - think about the customer journey from start to end. Where can you add value?


This is where you can really set your business apart from the competition

All the layers below this are standard tools that everybody is using . . .

Innovate with your customers

23

What are the benefits?

Case reference – a LIMS implementation

LIMS case reference

© 2015 Envigo

LIMS – Laboratory Information Management System

A demonstration of real business benefitsusing all the layers of a life sciences

platform

24

+ A LIMS – start to end information management application

+ Implemented with integrated laboratory instruments and

thin-client wireless computing, with ELN (Electronic Lab

Notebooks)

+ Dedicated infrastructure environment, hosted centrally

LIMS - case reference

25

INFRASTRUCTURE

DATA CAPTURE




Dedicated infrastructure environment for LIMS multiple sites on WAN & private cloud

Start-to-end one online efficient data capture

Data managed, processed and tracked in LIMS

Automated statistical analysis and interpretation

Reported on-line, customer formats

+ Prior to LIMS

+ Multiple legacy applications including Excel, paper forms and duplicated applications performing similar functions across business units

+ Labour intensive data checking and processing and high turn-around times for the customer

+ Duplication of data, transcribing data between applications

+ Lack of harmonised procedures between business units

+ Complex analysis and reporting process, with multiple hand-offs

+ Lost time due to transportation, waiting and queuing

+ Non competitive reporting times to the customer – loss of business opportunities

The need for change

26

27

INFRASTRUCTURE

Dedicated infrastructure environment for the LIMS hosted centrallywith sites in the US, EU and UK. Time sensitive data recording.

Integrated with barcode and laboratory capture equipment and linked to the LIMS application

Thin-client wireless computing, application streaming, dedicated virtual compute and storage platforms and Oracle RAC infrastructure

LIMS – case reference

DATA CAPTURE

28

All data captured on-line several million individual data recordings for each project

Before a high proportion of data was offline or in disparate applications, resulting in labour intensive data checking and reporting

After the data is online and has significantly reduced hours for data checking, analysis and reporting

LIMS - case reference

Dramatically improved data

integrity by automatic QC which

takes place as data is recorded

29


End to end business process as the project moves through the life cycle information is available at each stage online

ELN’s designed to capture all experimental data and integrated with the main LIMS applications

Information on the project available for the scientists and customer with real-time updates and ability to generate specific data formats

The business process of an entire project is captured and configured online within the LIMS – a single source of data with embedded workflows

LIMS - reference case


30

Ability to view and analyse data across multiple projects

Use background data to help with experimental design

Real time data that can be incorporated into data repositories for BI analytics

Bringing together data from

different disciplines to provide an

extensive cross-functional data

perspective



31

Provides a platform for customer collaboration

Insight into projects, by exposing information at key milestones and integration with potential for a customer facing application

Innovation – development of an internal statistical engine that makes analytical decisions based on the project design and data –completely automated data analysis


Benefits . . .

+ achieve higher laboratory capacity and still meet reporting timelines

+ produce customer report formats and statistical designs

+ produce data extract formats to meet new regulatory guidelines

+ produce background data to help improve study design and analysis

+ improve data quality, reporting efficiency and productivity

LIMS – tangible benefits

32

INFRASTRUCTURE

DATA CAPTURE



CUSTOMER COLLABORATION Reduced cost of

running studies

by 30% - able to

achieve higher

capacity and

improve reporting

Summary - life sciences technology platform

33

INFRASTRUCTURE

DATA CAPTURE




“Focus on all levels of the platform to deliver end to end technology solutions that are fit-for-purpose”

Enabling foundation

Core capability

Transformation

Insight

Innovation and value

An IT strategy to empower business on a fit-for-purpose technology platform

designed for life sciences


© 2015 Envigo 34

So how do you get there, what’s the plan?

How you get there – the plan

35

The next sections give some outline plans for each functional area of IT working towards the vision of a fit-for-purpose life sciences platform

Contents



business


Support ServicesThe face of IT

Systems ComplianceMeeting regulatory

guidelines


36

InfrastructureThe enabling foundation

© 2015 Envigo

Consolidate & build quality data centresScalable compute & storage

A well connected networkCentralise services and applications

A global business needs to be well connected

37


Consolidate to high grade data centres & build

out with standard

equipment

Assess & ensure the wide area

network is robust and well

connected

Move key services to data centres and put

in fail-overEnable local site

survivability

Keep voice, video, data &

applications on the business

network

1 2 3 4

38

The Cloud – “Somebody else's computer”

The key steps to build a reliable, scalable and secure infrastructure to

host applications & services

Infrastructure – high quality data centres


applications on the Envigo

network

2

3

4

39



survivability

Assess & ensure the private site

network is reliable and fast


out with standard

equipment

1

PRIMARY DATA CENTRE

PRIMARY DATA CENTRE

Assess all internal & external data centres

40

PRIMARY DATA CENTRE

ON PREMISE

TIER I

TIER II

TIER III

TIER IV

Single path for power & cooling, no redundant components

As below, with redundant components

Multiple power & cooling paths, redundant components

As below, and fault tolerant

Ranges from shared comms room to full redundant data centre

+ Assess the quality of all data centres on premise and leased

+ Consolidate to fewer quality data centres and standard platforms

+ Leased compute services versus co-location – Opex versus Capex

+ Look at total cost of ownership over 3-5 years, include the FTE to maintain co-lo

+ Ensure the data centre can cross-connect to your private network

+ Connect to public cloud services like SF.COM & Azure via your WAN

Facility/Site Tier

Floor Space

Capacity (SQ FT)

Floor Space

Usage (SQ FT) Usage

WAN Fault

Tolerance

MPLS

Bandwidth Internet Power Cooling

On-Site

Generator

UPS

(DC Floor)

UPS

(RACK)

Applications

Hosted

Site A No 1130 400 37% Yes 40 Mbps 20 Mbps Dual Feed Yes Yes Yes Yes Yes

Site B No 500 150 30% No 2 Mbps 20 Mbps Single Feed Yes No No Yes Yes

Site C TIER 3 150 90 60% Yes 100 Mbps 100 Mbps Dual Feed Yes Yes Yes No Yes

Example plan to rationalise data centres

Legacy equipment, poor access

Decommission and migrate services

Site ARationalise

Legacy equipment, good access

Reduce dependency, run legacy services

Site BOn premise

Good equipment, good access

Increase dependency, act as fail over

Site C FailoverTier 3

Reduce dependency, migrate key services

Site DOn premise

PRIMARY DATA CENTRE

PRIMARY DATA CENTRE

Modern & legacy equipment, single access

Increase dependency, host key services

Site E PrimaryTier 3

PRIMARY DATA CENTRE

Good equipment, good access

PRIMARY DATA CENTRE

PRIMARY DATA CENTRE

PRIMARY DATA CENTRE

PRIMARY DATA CENTRE

PRIMARY DATA CENTRE

PRIMARY DATA CENTRE

41

Migrate from a mixture of

compute, storage and networking

technology

Critical

for GxP data

and

applications

To standard

platforms across all

data centres

Easier to maintain,

scale and support

Reduces total cost

of ownership

+ Engage with a single global supplier

+ Agree on technology platforms

+ Standardise equipment

+ Start to replace legacy

+ Host legacy hardware in container architecture

Standard,

qualified

Platform

Easier to

manage &

reduced

cost of

ownership

Standardise equipment

42

Site A

Site C

Leased Data Centres

Site A

Fewer compute platforms

Few storage platforms

HP, Dell, DEC, SUN, HP Alpha . . .

HP, EMC, Co-raid, Quantum . . .

43

Standardise equipment

Site B

Infrastructure – the private wide area network


applications on the network

3

4

44



survivability


out with standard

equipment

1


network is meeting the

business need

2

WA schematic

Wide Area Network utilising a single provider, capable of delivering QoS and guaranteed SLA, critical to ensure services can be centralised

45

Infrastructure – the private network

WAN schematic

+ Network providers struggle with sub-contracted circuits

+ The “last mile” is normally sub-contracted to local providers

+ Getting the service & reliability to all sites is a challenge

+ Constantly monitor & assess performance against SLAs

+ Review circuits continually for local improvements

The challenges with network service

46

+ Work with your network provider, monthly service reviews

+ Many will upgrade circuits for no additional cost as

new technology becomes available

+ Introduce circuits that are not “capped” and will “burst”,

allowing you to use more data, start with lower bandwidth!

+ Asses the benefits of WAN acceleration appliances

The good news on network service

47

+ Start with applications

and services that are

already WAN sensitive

like Active Directory,

Exchange (DAG groups)

and telecoms (call

managers)

+ Then move onto

business applications

like ERP and more

proprietary apps like

LIMS

+ Build in fail-over

+ Provide local equipment

for performance and

short-term survivability

Infrastructure – moving services & applications

48



4


out with standard

equipment

1



2



survivability

3

+ By focussing on high

quality data centres on

the network and

improving access for all

sites…

+ …you can rationalise &

centralise key

applications and provide

access to these services

to all business units/sites

+ Anything you host is

available for all sites

applications like ERP,

and LIMS, reducing the

barrier to entry for small

business units

Infrastructure – Using the network

49


out with standard

equipment

1



2



survivability

3



4

+ A converged telephony approach+ Host centralised redundant call managers, leased or co-lo

+ Gateways from each site to the nearest call manager

+ Bridge mail/video using SIP

+ Put internal voice traffic across the private network

+ Mobile telephony approaches+ Reduce costs look for a global deal that

+ includes handset and technology fund

+ Allows unlimited international data roaming

+ Includes mobile device management

+ Security

+ Information management

+ The desktop environment

Infrastructure – other key areas to standardise

50

Contents



business



Systems ComplianceOur commitment to

quality


51

© 2015 Envigo 52

ApplicationsThe way we do business

Rationalise & standardise onto quality applications

Address risks, benefits and valueDevelop a roadmap for deployment

Applications – the way we do business


Create an application inventory

Assess risks, costs, benefits, and focus on value for the

customer

Develop guidelines and principles for application selection

Develop a roadmap with the business

1 2 3 4

53

The key steps to build an application roadmap that delivers value to

employees and customers

Applications – understand the current state


2

3

4

54


Assess risks, benefits, and

focus on value for the customer



1

Assessed against

+ Age

+ Usage

+ Support

+ Compatibility

+ Stability

+ Known Issues

+ Patient Proximity

+ Business Critical

+ Mitigation

Applications – understand the current state

55



Applications – assess risk, costs and benefits


3

4

56


Assess risks, costs, benefits, and focus on value for the

customer

1

2

Applications – assess risk, costs and benefits

57

Critical Apps healthy zoneCritical Apps loss zone

Less critical Apps loss zone Less critical Apps healthy zone

Inefficient, costly to run and maintain, consume

significant resource and reduce business efficiency

Efficient and up to date, easier to maintain

and improve business efficiency

Assessed against

+ Age

+ Usage

+ Support

+ Compatibility

+ Stability

+ Known Issues

+ Patient Proximity

+ Business Critical

+ Mitigation



+ Aligned with

Company

Strategy

+ Meets with the

strategic direction

of the business

+ Product line and

service area

initiatives

+ Growth

opportunities

organic or M&A

+ Cost reduction,

automation,

efficiency and

productivity

Applications – Develop application principles (1)

58

Assess risks, benefits, ROI and focus on value for the

customer

1

2


4


3



+ Compatible and

maintainable

+ Will operate on

current/new

infrastructure

+ Supported

internally and

externally

+ Quality supplier

+ Industry standard

architecture

+ Will integrate with

other applications


59


customer

1

2


4


3



+ Fit-for-purpose

+ Meets the

business

expectations and

requirements

+ Improves data

processing & data

management

+ Meets regulatory &

customer

expectations


60


customer

1

2


4


3



+ Delivers improvements to the business and customers by realising tangible benefits

+ Efficiency (reduce waste)

+ Productivity (increase capacity)

+ People (improve engagement)

+ Customers (improve service)

+ Profit (reduce cost)


61


customer

1

2


4


3



Applications – develop a roadmap

3

62


customer

1

2

What projects will mitigate risks and

deliver tangible benefits?

Develop guidelines and principles for application selection Develop a

roadmap with the business

4

+ Carry out a full inventory and full risk assessment using

agreed criteria and principles

+ Agree on the strategic roadmap

+ Mitigate the high risk items but ensure mitigation is in line

with strategic objectives

+ Continue to manage the business as usual

Application portfolio investment strategy

63

10%Research & Discovery

Feasibility & innovation projects

30%Strategic projects

That also mitigate high

risks

60%Business As

UsualManaging the

applicationlife-cycle


based on similar categories

1 2 3 4

Contents



business



ComplianceMeeting regulatory

guidelines


64


© 2015 Envigo

A Project Management OfficeGovernance and standard project

methodologyProject priorities decided by the business

65

Projects – the force for change

Form a Project Management

Office

Develop governance and

project methodology

Meet with the business to decide on priorities

Keep track of all IT company

projects across the business

1 2 3 4

66

The key steps to prioritising and managing all IT company projects

across the business



2

3

4

67



project methodology

Form a Project Management

Office(PMO)

1


+ Form a PMO to manage

strategic projects like

the Application Roadmap

and Infrastructure

strategy

+ A team experienced at

managing global IT

application and

infrastructure projects

+ A mixture of internal and

partner collaboration



3

4

68


Formation of a new Envigo

Project Management

Office

1


+ Develop a set of

governance controls and

standard project

documentation

+ A robust process for

selecting suppliers (RFP)

– Fixed price projects

+ Project methodology

+ Red Amber Green

weekly status reports

+ Monthly progress reports


project methodology

2

Programme Manager: Graham Gaut Review Date 18/10/2015

Programme Title: Swiss DC Exit Decommissioning Programme Period From 10/10/2015

Phase/Stage: Delivery Period To 17/10/2015

Overall Project RAG and Summary Status Green

Overall programme status Green, as no issues or risks currently exist that will have a material impact on the overall timeline or agreed costs at this stage (although a need for EMKA parallel running into March will have a material impact if confirmed by Rex).

Infrastructure Assessment documents continue to be being produced in line with the programme plan: SQL Server and OpenVMS documents reviewed and issued for sign off; Network Management Server document in internal review. Sync jobs split so they complete within the allotted weekday and weekend copy windows (N.B. There is a current concern around the copy execution windows being sufficient – to be reviewed once WAN acceleration is in place).

SSA (Wave 2a): 12 applications have been decommissioned; 3 applications have issues which are being actively investigated (Chromeleon, Flo One Analysis and Spectrum ES). CSA Wave 2: ABACUS decommissioning process completed. CSA Wave 3: EMKA Infrastructure Assessment document reviewed and issued for sign off.

Active RAID Items R A G Total

Resource Usage @ 16/10/15 P.O. Used To Use Kelway

Expenses (To 09/10)

Amount (Ex. VAT)

Assumptions: 0 18 79 97 KW Programme Manager: 311.00 (161.25) 149.75 Available: £30,000.00

Open Risks: 0 7 27 34 KW Project Manager: 207.50 (123.00) 84.50 Used: (£7,023.65)

Open Issues: 0 2 0 2 KW Solution Architect: 301.00 (153.00) 148.00 Remaining: £22,976.35

Open Actions: 0 1 8 9 KW Consultant (L6) 571.50 (268.50) 303.00

Change Priority 1 2 3 4 5 KW Consultant (L5) 257.00 (114.50) 142.50

Open Changes: 0 3 0 0 0 KW Consultant (L4): 48.00 (15.00) 33.00

TDV Project Manager: 239.00 (83.00) 156.00

TDV Consultant: 20.00 (5.00) 15.00



4

69


Project Management

Office

1


+ Meet regularly with the

business to assess new

project requests,

progress updates and

priorities

+ Develop the project

portfolio with the

business to get buy-in

and communicate to

the key stakeholders


project methodology

2










Expenses (To 09/10)

Amount (Ex. VAT)








TDV Consultant: 20.00 (5.00) 15.00


3

70


Project Management

Office

1


+ Keep track of the

complete project

portfolio, resources,

tasks, budget, quality

and issue management

+ Red, Amber, Green

updates

+ Getting buy-in, projects

bring change and

communication is key

+ Produce easy to read

updates and reports for

the business and to all

stakeholder groups


project methodology

2


3



4










Expenses (To 09/10)

Amount (Ex. VAT)








TDV Consultant: 20.00 (5.00) 15.00

Contents



business



Systems ComplianceMeeting regulatory

guidelines


71

© 2015 Envigo 72


Standardise onto a single helpdeskSupport the business across multiple

countries & time-zonesDevelop SLA’s with the business

The best way to find yourself is to lose yourself in the service of others

Support Services – the face of IT

Standardise onto a single

global Helpdesk tool

Develop the support function across the world and time-zones

Develop SLA’s with the business

Keep track of metrics and

quality

1 2 3 4

73

The best way to find yourself is to lose yourself in the service of others.

The key steps to developing a world class support service


quality

2

3

4

74





1 + Implement a global

Helpdesk tool across the

business

+ Self-service portal for all

users

+ Knowledge base to

improve first-time

resolution

+ Ensure it has the

functionality to control the

many IT processes and

records – ITIL compliant



quality

3

4

75




1 + Whether helpdesk is out-

sourced, internal or

hybrid ensure all

incidents are captured &

managed centrally

+ Resolve common

incidents with problem

management

+ Large geography & no

on-site IT, utilise local

support as needed



2


quality

4

76



1 + As you collect more

incident and problem

data across all the sites,

services & applications –

start to develop refined

SLAs

+ Agree on the critical

services & applications

+ Measure the service

against the SLAs



2


3

77

+ Produce metrics on SLAs for the business

+ Distribute workload evenly across support

functions

+ Survey the user community to ensure you are

meeting their requirements



quality

4

Contents



business



Systems ComplianceOur commitment to

quality


78

Systems ComplianceMeeting regulatory guidelines

© 2015 Envigo

A dedicated function Focussed on ensuring systems meet the

regulatory guidelinesProject priorities decided with the business

79

Systems Compliance – Meeting regulatory guidelines

A dedicated computer

compliance function

Bringing the standards

together for validation

Working with QA and operational management

Determining project priorities

with the business

1 2 3 4

80

The key steps to ensure you meet the regulatory guidelines


with the business

2

3

4

81

Working with QA and

management



A dedicated computer

compliance function

1 + Create a dedicated

computer compliance

team focussed on

validation and

qualification for GxP

+ Specialists in GAMP a

risk based approach to

manufacturing practice

+ Needs to be a separate

functional group to

prevent a conflict of

interest



82

New dedicated computer

compliance team in IT

1



2

+ Industry best practice (GAMP 5)

+ Improved quality and compliance+ Effective Governance to achieve and maintain

GxP Compliance

+ Reduced cost of compliance+ Scalable approach to GxP compliance

+ Reduced time of delivery+ Improving GxP compliance efficiency

+ Continuous improvement within QMS

+ Reduced compliance risk+ Focus on public safety, product quality, and

data integrity

+ Science based quality management of risks


with the business

2

4

83



1

+ Work closely with QA

management

+ Meeting with

operational

management to

present guidelines

and get buy-in for

change

+ Ensure the

application roadmap

and other IT projects

will meet the

regulatory guidelines



together for validationWorking with QA

and operational management

3

2

84



1

+ Working with the

business on new

requests and project

priorities

+ Understanding the

workload for validation

and qualification projects

+ Managing the project

portfolio going forward


3Bringing the standards

together for validationWorking with QA

and CRS managementDetermining

project priorities with the business

4

Summary - Life Sciences technology platform

85

INFRASTRUCTURE

DATA CAPTURE




“IT and the business working together to build a technology

platform to empower your business to succeed!”

Enabling Foundation

Core capability

Transformation

Insight

Innovation & value

it strategy for life sciences david royle

Technology