Coristo Customer Info Day PSM Product Structure Management · hematology, coagulation and third parties. 9 Integrated Core Lab The future starts now Pre-analytical systems Automated

Coristo Customer Info Day

PSM Product Structure ManagementBeat Meier / Martin Behnke – Roche

Mirko Quintern – Coristo

2

Agenda

Roche basic facts

- History

- Solution Overview

- Strategic roadmap

Project Overview – UniteD

- Unite multiple SAP Systems in one new SAP System

- Configuration Management with SAP PSM (Product Structure management)

Achievements and Outlook

- Comparison Past Today

- Observation with introduction of PSM and Configuration Management

- Q&A

3

Roche basic facts at a glance

• Clear focus on healthcare and unique innovation model

• World’s largest biotech company with truly

differentiated medicines in oncology, virology,

inflammation, metabolism and Central Nervous System

(CNS)

• Leadership in in vitro diagnostics

• Founded 1896 in Basel, Switzerland

• Founding families still hold majority stake

*Dow Jones Sustainability Index (DJSI)

Employing 93,734people

Sales of CHF 53.3 billion

R & D core investments of

CHF 10.4 billion

30 Roche medicines on

the WHO Model List of

Essential Medicines

137 million patients treated

with Roche medicines

19 billion tests conducted with

Roche Diagnostics products

10 years in a row ranked as

sustainability leader by DJSI*

150+ new partnerships in

Diagnostics and

Pharmaceuticals

4

Roche is a global pioneer in personalised

healthcareWe work across diagnostics and pharmaceuticals

Innovation is in our DNA

#1 R&D investor in healthcare

Among top 10 R&D investors across industries

CHF 10,392 million R&D

investment

30 R&D sites worldwide**

CHF 53,299 million Sales

26 Manufacturing sites worldwide

**Pharmaceuticals and Diagnostics* Strategy & Global Innovation 1000, Winter 2017

5

Division DiagnosticsGlobal market leader of In-vitro Diagnostics (IVD)

6

Organisational Structure DiagnosticsBusiness Areas and Units

Centralised & Point of Care

Solutions

Serum work area, Point-of-care testing, Specialty

testing, Lab IT and Workflow Mgmt., Custom

Biotech.

Molecular SolutionsMolecular Diagnostics , Tissue Diagnostics,

Sequencing Solutions

R/T PCR, Virology, Blood screening, Genomics/

Oncology, Microbiology, Biochemical reagents.

Primary & Advanced staining, Workflow Mgmt.

Diabetes Care

Blood glucose monitoring, Insulin delivery,

Diabetes workflow management.

7

TISSUE DIAGNOSTICS MOLECULAR DIAGNOSTICSSEQUENCING

CENTRAL LAB Point of Care

Roche Diagnostics - PortfolioTranslating cutting-edge science & innovation into practice

8

Roche Diagnostics - Strategic roadmap From physical to virtual connectivity

Today

Best in Serum Work Area

We shaped the market by

connecting clinical

chemistry and

immunoassays to create

Serum Work Area

2022 Vision

+ Integrated diagnostic information anywhere, anytime

Making diagnostic information

from core labs, satellite labs, PoC

and patients available where and

when it is needed

Tomorrow

Best in Connected

Core Laboratory

Connecting further

disciplines including

molecular diagnostics,

hematology, coagulation and

third parties

9

Integrated Core LabThe future starts now

Pre-analytical systemsAutomated sample preparation

Post-analytical systemsAutomated sample archiving

AnalyzersAnalyzes sample

Workflow & IT

SolutionsCoordinates the integration

of the lab cobas®

connection

modules transportation

system

Bulk loaderSample loading

Data analyticsInformation displayed on screen

10

Agenda

Roche basic facts

- History

- Solution Overview

- Strategic roadmap







- Q&A

11

Penzberg

Mannheim

RotkreuzPleasanton

TucsonIndianapolis

Branchburg

Madison

Replacement of current IT systems for Enterprise Resource Planning (ERP)

with a single modern platform (SAP ECC 6.0) in Dia R&D and manufacturing

sites

Involved FunctionsAffected Business Areas /

UnitsSAP Systems

Waiblingen (PVT)

Kapa Biosystems Massachussets

Ariosa San Jose

Project UniteD - big pictureProduct - Target IT Landscape Perspectives

Global Operations

Global Supply Chain

Global Direct Procurement

Operations Finance

Global Quality & Regulatory

Core Finance

Global Indirect Functions

Site Services

Informatics

Dia Research & Development

Molecular Diagnostics

Professional Diagnostics

Tissue Diagnostics

P86 (Wave 1)

US1 (Wave 1)

P70 (Wave 2)

None SAP

Systems

PVT (Wave 3)

Ariosa / KAPA

(Wave 4)

12

UniteD Adjusted Wave ScheduleDefine Phase PLM / IM Wave 2

13

UniteD ProjectAfter an exciting, challenging and successful journey, UniteD is

2018 live in 10 sites around the globe

14

Agenda

Roche basic facts

- History

- Solution Overview

- Strategic roadmap







- Q&A

15

15

DHF DHF DMR DHR

CENIT / expi

CATIA V5SolidWorks

Configuration Management UniteDProduct - Target IT Landscape Perspectives – Big picture

16

Configuration Management UniteDExcel was starting point for configuration documentation

16

Hardware

Software

Reagents

Entire system

Consumables

Parameter Sets

CI-FM 0.2 CI-FM 1.0 CI-FM 1.0 CI-FM 1.0 CI-FM 1.0

AC2.2 AC3.3 AC3.4.1 AC3.4.1 AC Rev D

Scope

Sprint Sprint SW FM 6.2 SW FM 6.2 SW FM 6.3 SW FM 6.4

SW FM 6.4 + Patch

- definition file update for

testspecific cassettes (RL9)

Iteration

Parameter Files

Lysis Kit RL 4 RL5, RL6 RL6, RL7 RL7, RL8 RL 9

Wash reagent-Kit RL 4 RL5, RL6 RL6, RL7 RL7, RL8 RL 9

MGP-Kit RL 4 RL5, RL6 RL6, RL7 RL7, RL8 RL 9

Spec-Dil Kit RL 4 RL5, RL6 RL6, RL7 RL7, RL8 RL 9

HEV 96 Kit

HEV 480 Kit

HEV RMC Kit

HEV RMC Kit NPsep

HBV 96 Kit RL 4 RL5, RL6 RL6, RL7 RL7, RL8 RL 9

HBV 480 Kit

HCV Kit 96 RL7, RL8 RL 9

HCV Kit 480

HIV 96 Kit RL 4 RL5, RL6 RL6, RL7 RL7, RL8 RL 9

HIV 480 Kit

HxV RMC Kit

HxV RMC Kit NPsep

MPX Kit 96 RL 4 RL5, RL6 RL6, RL7 RL7, RL8 RL 9

MPX Kit 480

MPX RMC Kit

MPX RMC Kit NPsep

WNV Kit 96 RL 4 RL5, RL6 RL6, RL7 RL7, RL8 RL 9

WNV Kit 480

WNV RMC Kit

WNV RMC Kit NPsep

CMV Kit 96 RL7, RL8 RL 9

CMV Kit 480

CMV RMC Kit

CMV RMC Kit NPsep

DPX Kit 96 RL7, RL8 RL 9

DPX Kit 480

DPX RMC Kit

DPX RMC Kit NPsep

MGP-Cassette V02 MGP-Cassette V02.X MGP-Cassette V03.X MGP-Cassette Rev G

Reagent Cassette low volume

V01


V03.X


V03.XReagent Cassette 96 Rev B

RMC Cassette V01.X RMC Cassette V01.X RMC Cassette Rev F

Specimen Diluent Reagent

Bottle


Bottle


Bottle Rev B

Lysis Reagent Bottle Lysis Reagent Bottle Lysis Reagent Bottle Rev B

Wash Buffer Bottle Wash Buffer Bottle Wash Buffer Bottle Rev B

V03, encrypted content with

API

P-plate 48 V03.1

- optimized footprint

(new molding process

parameters)

P-plate 48 V04.0


(new mold cooling)

P-plate 48 V04.X

- manufacturing with injection

molding machine Netstal Elion

- packaged with secondary

flat box, content 32 pieces

(only for development)

P-plate 48 V05.X

- longer barcode label with

additional content of expiry date

and version ID


"cube" box, content 32 pieces

(similar to serial packaging)

P-plate 48 Rev C



and version ID




Combo-tip Rack 48 V04.0

- 3-piece rack

- with 48 P-tips 1ml and 48 E-

Tips

0.3ml from Hamilton

- System Development

assembles

the racks with the Hamilton

Tips


- 1-piece rack


Tips

0.3ml from Hamilton


assembles


Tips

Combo-tip Rack 48 V07.X

- optimized footprint of

Combo-Rack




and version ID

- included Process-waste Insert




Combo-tip Rack 48 Rev C



and version ID





AD-plate 96 V07.0

- without Cassette

- 5 AD-plate initial in banderole

- without barcode label

AD-plate 96 V09.1

- with 1.7mm deeper wells

- with barcode label and

orientation check label on

AD-frame, with barcode

label on AD-plate blank 1C

AD-plate 96 V09.X



AD-frame, without barcode


AD-plate 96 V09.X





AD-plate 96 Rev C



and version ID

- 4 AD-plates initial into a

cassette




RFID

C-FM 1

Hardware

C-FM 2 C-FM 4C-FM 3 C-FM 5

Estimated Timeline

Configuration Baseline

De

sig

n A

sp

ec

t

Pooler Instrument

Single use Consumables

WDO 10461573 V00

Analytics Instrument

Main Configuration

Items

Software

Generic Reagents

Assay specific reagents

Reagent Packaging Consumables

WDO 10457774 V00

17


AC2.2 AC3.3 AC3.4.1 AC3.4.1 AC Rev D

Scope


SW FM 6.4 + Patch



Iteration

Parameter Files





HEV 96 Kit

HEV 480 Kit

HEV RMC Kit

HEV RMC Kit NPsep


HBV 480 Kit


HCV Kit 480


HIV 480 Kit

HxV RMC Kit

HxV RMC Kit NPsep


MPX Kit 480

MPX RMC Kit

MPX RMC Kit NPsep


WNV Kit 480

WNV RMC Kit

WNV RMC Kit NPsep


CMV Kit 480

CMV RMC Kit

CMV RMC Kit NPsep


DPX Kit 480

DPX RMC Kit

DPX RMC Kit NPsep



V01


V03.X





Bottle


Bottle


Bottle Rev B




API

P-plate 48 V03.1



parameters)

P-plate 48 V04.0


(new mold cooling)

P-plate 48 V04.X






P-plate 48 V05.X



and version ID




P-plate 48 Rev C



and version ID





- 3-piece rack


Tips

0.3ml from Hamilton


assembles


Tips


- 1-piece rack


Tips

0.3ml from Hamilton


assembles


Tips



Combo-Rack




and version ID








and version ID





AD-plate 96 V07.0

- without Cassette



AD-plate 96 V09.1






AD-plate 96 V09.X





AD-plate 96 V09.X





AD-plate 96 Rev C



and version ID


cassette




RFID

C-FM 1

Hardware


Estimated Timeline


Desig

n A

sp

ect

Pooler Instrument


WDO 10461573 V00


Main Configuration

Items

Software

Generic Reagents



WDO 10457774 V00

Configuration Management UniteDEvery Excel for each project was different

18

Configuration Management UniteDSystem Decomposition Guidance for GPS

QAP System

Architecture

SOP System

Comp. Standard

System Decomposition

19

UniteD: Config ManagementSystem Decomposition with PSM

20

UniteD: Config ManagementSystem Decomposition with PSM

Two separate “Layers” in PSM with project & product documentation

The Product Structure consists of Material Masters (Config. Items)

21

UniteD: Config ManagementExample: Cobas P612 in PSM

Simple & incomplete example of the HW decomposition

Decomposition contains system component “Instrument” & Units

22

Configuration Management UniteDFrom Excel to SAP Product Structure Management

Hardware

Software

Reagents

Entire system

Consumables

Parameter Sets

23

UniteD: Config ManagementProduct Structure with PLM Configuration Items

Each Component has a Config

Item (Material Master) assigned

Each Material Master has a

defined Maturity Level

To each material revision a set of

valid documents exists for this

date

Documents are grouped via Data

Packages

24

UniteD: Config ManagementReuse of Platform Elements

24

25

UniteD: Config ManagementVariant Configuration for specific products

26

UniteD: Config ManagementLifecycle of Configuration Items

27

Agenda

Roche basic facts

- History

- Solution Overview

- Strategic roadmap







- Q&A

28


AC2.2 AC3.3 AC3.4.1 AC3.4.1 AC Rev D

Scope


SW FM 6.4 + Patch



Iteration

Parameter Files





HEV 96 Kit

HEV 480 Kit

HEV RMC Kit

HEV RMC Kit NPsep


HBV 480 Kit


HCV Kit 480


HIV 480 Kit

HxV RMC Kit

HxV RMC Kit NPsep


MPX Kit 480

MPX RMC Kit

MPX RMC Kit NPsep


WNV Kit 480

WNV RMC Kit

WNV RMC Kit NPsep


CMV Kit 480

CMV RMC Kit

CMV RMC Kit NPsep


DPX Kit 480

DPX RMC Kit

DPX RMC Kit NPsep



V01


V03.X





Bottle


Bottle


Bottle Rev B




API

P-plate 48 V03.1



parameters)

P-plate 48 V04.0


(new mold cooling)

P-plate 48 V04.X






P-plate 48 V05.X



and version ID




P-plate 48 Rev C



and version ID





- 3-piece rack


Tips

0.3ml from Hamilton


assembles


Tips


- 1-piece rack


Tips

0.3ml from Hamilton


assembles


Tips



Combo-Rack




and version ID








and version ID





AD-plate 96 V07.0

- without Cassette



AD-plate 96 V09.1






AD-plate 96 V09.X





AD-plate 96 V09.X





AD-plate 96 Rev C



and version ID


cassette




RFID

C-FM 1

Hardware


Estimated Timeline


De

sig

n A

sp

ec

t

Pooler Instrument


WDO 10461573 V00


Main Configuration

Items

Software

Generic Reagents



WDO 10457774 V00

Comparison Past vs. TodayProduct Configuration

Past

• Project-scope configuration only

• In Excel /Word documented

• Configuration not complete

• Each project used own template for decomposition

Today

• Complete product and project configuration

• Related documentation in SAP Document Management (LOD List of deliverables)

• Same template for all

29

Comparison Past vs. TodayStatus Reporting

Past

• Excel based

• Disconnected from project maturityand product

• Many different files

• Manual effort

Today

• Full visibility on project, product andrelated documentation status and maturity

• Complete report for LOD, DHF, DMR

• Complete overview about all implemented and planned changes on all product items

• …all by standard report … generated in seconds

30

Comparison Past vs. TodayBaselines

Past

• Excel based

• Disconnected from the product BOM

• Many different files

• Manual effort

• Changes implemented in operations continuously

Today

• In SAP available

• Manageable based on changes and effectivity

• Packaging of changes possible

• Configuration baselines as designed and production lots manageable

31

Configuration ManagementNeed for improvement

• Customer satisfaction (CM, R&D, Ops)

• commitment of Project Teams for CM

• CM Process and Tool perceived as complicated

• Trust in CM

• Action List of 22 open topics by R&D

Need for Improvement started Q1 2018 Improvement Initiatives Q2/Q3 2018

Kick-off Workshop

Cluster Workshops

Final Workshop

CM BPM Meeting

32

1. Evaluation

a. Are all stakeholders known and represented?

b. Is relevant business process mature enough?

c. Is real way of working known?

2. Investigation

a. Is the need of critical users known?

(stakeholder)?

b. Is impact to processes / tools known?

c. Is new tool / process and way of working

matching?

3. Consolidation

a. Are critical users committed?

b. Is management committed?

4. Verification

a. Is accountability for implementation clear?

b. Key user not trained before go-live

Configuration ManagementRoot causes for findings

Phases of root causes in PLM CM project Key root causes

Validation

Verification

Customer need Customer satisfaction

1

2

3

4

Go-live Oct. 20162015

2016

33

Configuration ManagementAchievements

Improvement Initiatives Q2/Q3 2018 Achievement Q3 2018

• Needs for improvement identified with R&D and

Ops

• CM process improved and synchronized in close

collaboration with R&D and Ops stakeholders

• CM BPM meeting and continual improvement

established

• SAP CMT Meeting and continual improvement

established

• CM commitment improved

• Operational CM role in development projects

34

Q&A

Question&Answer

35

Doing now what patients need next