5 critical steps for successful rim adoption · 2019-10-30 · webinar: paul attridge sr. director,...

Five Critical Aspects for Successful RIM Adoption

29 October 2019

Webinar:

PAUL ATTRIDGESr. Director, Vault RIM

Veeva Systems

NIELS BUCH LEANDERPh.D., Global Head of

Regulatory Affairs

ANNE POUZETSenior Advisor

33Copyright © Veeva Systems 2019

AGENDA

Five critical aspects for successful RIM adoption1. Building a Business Case

2. Managing Data

3. Governance

4. Organizational Change

5. Continuous improvement


Leading Provider Cloud Solutions to the Global Life Sciences Industry

Founded in 2007 2,800+ Employees HQ in Pleasanton, CA


Global IT power house supporting the Life Sciences Industry

- and a key Veeva implementation partnerFounded in 1994 3,300+ Employees HQ Copenhagen, Denmark


Building a Business case

Data Quality & Data Management

Governance & Data exchange

Organizational changes

Continuous business improvement

Building a Business Case

Poll #1

Building Business Case



RA Business Case

STAKEHOLDERSIdentify roles and responsibilities for

both project and operation

PROJECT BRIEFDetailed description

and timelines

RISKSIdentify problems

and set risk measures

BENEFITSWhat are the

advantages and what benefits will

they bring?

COSTSWhat are the

expected costs on project elements

and later operation?

SCOPE & ASSUMPTIONS

Identify scope and list assumptions

for the project


NNIT RIM scope definitions and benefits

Building Business CaseBusiness Case: Example

NNIT business case template

RA Capabilities

Program and Project approach

Benefits

Transformation Strategy


RA Transformation Strategy and Business case

Year 0 Year 2 Year 3 Year 4 Year 5

Year 5

Year 4

Year 3

Year 2

Year 1

FO

5:

Aff

ilia

te S

etu

p

FO

4:

Syste

m

In

teg

rati

on

FO

3:

Au

tom

ati

on

FO2: Regulations Readiness

FO1: Information Model

Year 1

Evaluate current RA capabilities and as-is maturity assessment

Identify future capabilities to support business strategy, reg. requirements and tech trends

Workshops with RA: maturity, success factors and business impact of key capabilities

Consolidation of capability heat maps across RA and set digital KPIs

Proposal on strategic projects and roadmap across RA. Adjustment of organization.

0

1

2

3

4

5

1 2 3 4 5


Building Business CaseNNIT RA Strategy and Benchmarking

RA Maturity Assessment

3.3

4.74.4

4.1

0

1

2

3

4

5

Systems Processes People Total

Business Impact Economics Resources Quality

Functional Capability Scor

e

Stra

tegi

c Va

lue

Busi

ness

Val

ue

Flex

ibili

ty N

eed

Redu

ced

Com

plex

ity

Cost

Eff

ectiv

enes

s

Reso

urce

O

ptim

izat

ion

Redu

ced

Trai

ning

N

eed

Incr

ease

d Pr

oduc

t Q

ualit

y

Incr

ease

d Pr

oces

sed

Qua

lity

Ease

s Leg

al o

r Reg

. Co

nstr

aint

s

Remarks

XYZ 48 5 4 5 3 2 2 4 4 4 3 Long-term target

XYZ 55 5 5 2 1 5 5 5 5 2 5 Legal & regulatory requirements

XYZ 38 3 4 1 4 3 2 4 4 3 3

XYZ 22 2 3 4 2 1 1 1 1 1 3

XYZ 40 5 5 2 3 2 3 1 1 5 5 Complex set-up

XYZ 30 2 5 4 2 5 3 1 1 1 1 Interfaces with HR, Cross-functional

XYZ 22 3 3 2 1 5 2 1 1 2 2 Interfaces with finances

XYZ 39 5 5 3 4 5 1 1 1 3 3 Interfaces with production

Color Agenda:

Positive Weighing Factor x 2

Negative Weighing Factor x 2

Number Agenda:

1

5

= Lowest;

= Highest

RA RoadmapYear 0 Year 2 Year 3 Year 4 Year 5

Year 5

Year 4

Year 3

Year 2

Year 1

FO5:

Col

labo

ratio

nA

ffilia

te S

etup

FO

4: D

ata

and

Inte

grat

ion

FO3:

A

utom

atio

n

FO2: Regulations and Intelligence

FO1:Organization

Year 1

Managing Data & Data Quality

Poll #2



Why focus on data quality?Data Quality &

Data Management

Challenge; consolidation of silosWhen moving from legacy systems to new solutions, issues and concerns regarding data quality and readiness may occur. New data models have new requirements to structure and consistency, challenging the move from legacy systems

Reason 1: Secure Data Readiness and Compliance

Challenge; data trustThe ability to trust data and the information it provides is crucial. We often blame reports and people, when in fact changes to systems and processes over time is at fault. Information is key and the information is no better than the data foundation

Reason 2: Reporting correctness and internal KPIs

VS


Establish Data model and ownershipData Quality &

Data Management

• Based on solution data model, define a holistic RA data model

Data Model

• Establish levels of data ownership with defined responsibilities:

Data Ownership

Data Migration Preparation Data Maintenance

AI-managed data quality

• Strategic level responsible • Tactical level

responsible • Operational

Business OwnerData Owner

Data Steward

Data Quality

PROCESSES

DATA MODEL

SYSTEMS DATA


NNIT’s Data quality frameworkData Quality &

Data Management

Preparation Quality Analysis Execution Remediation

• Source Data for Analysis• Target Data Model• Mapping Specification

• Extract Data from Source Systems

• Scope Target Data Model• Map Source Data to Target

Model

• Data Quality Rule Book• Automated Data Quality

Flows• Data Quality Results

and report• Gap plan

• Define Quality Rules• Configure Data

Quality Flows• Execute Data Quality Flows• Analyze Results

and Adjust• Report with

recommendations

• Plan for execution• Data corrections• Data validation• Setting up automatic checks

• Data governance execution• Data stewardship

assignment• Change management and

SOPs

Governance & Data Exchange

Poll #3



Governance areasGovernance & Data exchange

Implementation

Risk

Define roles & responsibilities

Progress overview

Timelines

Define data quality rules

Continuous Business Improvement

Secure compliance

Move change requests to implementation

Assess changes to system impact to business processes

Assess changes to business processes impact to system

Advise on implementation of changes

Operation

System admin and support

Perform data quality measures

Maintain security

System is available at all times


Impact on the submission processGovernance & Data exchange

Phase 1 Phase 2 Phase 3 Assessment Post-Approval Ph. 4

Investigational Products Authorised Products

Substance (API and Excipients)

CTA/IND xEVMiPD DSURINN

request eAF MAA/NDA eCTD xEVMPD PSUR and

variationsSPL

Device registration

Research NC, Clinical and CMC Safety Safety

FMD

ManufacturingRegulatory Affairs

Labelling development

Finalise Filing plan

Labelling development(Target product profile)

Clinical trial application

Scientific Advice


Submission planning

Pre-Submission meetings

Response To questions

Authoritymeetings Approval

Pricing &Reimbursement

Approve Promotionalactivities

Lifecyclemanagement

MAA submission Final label



Exchange of dataData Quality &

Data Management

Challenge:Receiving manufacturer information from production systems

Failed alignment with CTD requirements, and issues on scope limitation

Strict governance will allow for mapping of data i.e. using IDs delivering oversight/ one truth and trust in data

Case 1: Data import

Challenge: Submitting data for XEVMPD requires adherence to EMA specific requirements

Data harmonization can happen in RIM or outside of the system. Submitted data should be captured to secure oversight and ability to correct data if requested by the agency

Proper governance will secure the right level of control and ability to map back to data in RIM if needed

Case 2: Data export

Organizational changes


Changing the daily work in RAOrganizational

Changes

01Collaboration between affiliates and HQ, working on content plans

02Increased end-to-end understanding of process and data

03Working only in the system


Changing the support modelOrganizational

Changes

BUSINESS

End usersService desk /

Screening

APPLICATION SUPPORT

Application

Product & BackendSIN

GLE

PO

INT

OF

CON

TACT

Technical & Functional


Changing the IT and business collaborationOrganizational

Changes

BACKLOG ASSESSMENT- What is the business need?- What are the benefits?- What is the effort?- How fast to implement?- Impact?

Veeva General Release features

Business & Regulatory

Requirements

General releases (3 annual releases, auto-on)

Customer Releases

BACKLOG

Change Advisory Board / Product Owner

DEFER

IMPLE-

MENT

DO NOT

IMPL

E-M

ENT

PROTO

TYPE

PRIORITY

EFFO

RT

THEME

USER

STORY


Essential Ingredients To Success Continuous business

improvement

Application Services

Continuous Improvement

Customer Business Life-Cycle

Mgmt.

ApplicationSupport

Org. changes

Regulatorychanges

New markets Change in application landscape

New best practices

Example: EU Medical device regulation


Maximizing the investment

Customer Release”Configurable” features

General Release”Auto-on” features

Stay validated Maximize business value

1 2



Doing a Customer Release Example plan and role distribution

Customer

Production - Change freeze

WK-6 WK-5 WK-4 WK-3 WK-2 WK-1

V P

SPRINT 1

WK 0

Prepare Change Document

Re-assess features and scope Estimation Configuration and Implementation Testing & Validation

QA Approval

Develop test protocols Test Integrations Update System documentation

Update and approve Validation report

Release announcement to system users

Final End user announcement

User Training

Releasego-live

Clone PROD to DEV and VAL

Transfer Configuration from DEV to VAL

Transfer Conf. from VAL to PROD

Config TransferConfig Transfer

Conf

ig T

rans

fer

Hypercare

Veeva Customer Success and Managed Services Support

Backlog Management


Call-to-action• A business case is to guide you

through from initiation to operation• A business case should address

business benefits, not just IT benefits• A business case should be aligned

with a RA strategy • Prepare for organizational change• IT and business to work closely

together• Data quality needs a constant focus and a plan

• Data quality cannot be solved without governance/data ownership

• Know your data model• Operation not just to focus on

keeping the system validated & operational, but on continuous improvement (DevOps)

• NNIT and Veeva collaborate on support

• Increase in data exchange with externals

• Increase in data exchange with other business units within the company

Questions

18 – 20 May 2020 | Barcelona, Spain

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700+attendees from

life sciences

140+life science companies

Join our European R&D Community

Develop New Industry Partnerships

Share Best Practices

Network with Peers

www.veeva.com/eu/events/rd-summit/

PAUL [email protected]

NIELS BUCH [email protected]

ANNE [email protected]

Thank you

5 critical steps for successful rim adoption · 2019-10-30 · webinar: paul attridge sr. director,...

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