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Strategy  and  Architecture  to  

Establish  'Smart  Plants'

 

(2)

Enterprise    

on  HANA  

S&OP  

Sen2ent  

Track  &    

Trace  

BI  

Sequencing  

Innova2on  

DSIM  

We  are  a  solu*on    provider  of  

Business  Applica:ons  

focused  on  

orchestra*ng  

Customer  Value  Networks  

in  the  changing  

SAP  Enterprise

 

technology  landscape.    

(3)

About  Intrigo  

Products  

Services  

Predic:ve   modeling;   Sen:ent;  e-­‐ Serve     BW  on  HANA   Biz  Suite  /   Optessa   SOP  on  HANA  /    

DSIM  /  APO  on   HANA  

Solu2ons    

In-­‐ m em or y   co mp u2n g  

BUILT ON

HANA

Orchestra:ng   Customer   Value   Networks  

(4)

Mylan  –  Company  Overview  

§

One  of  the  world’s  leading  pharmaceu*cal  companies  

§

Sells  products  in  approximately  140  countries  and  

territories  

§

Global  manufacturing  capacity  of  approximately  54  

billion  doses  

§

Horizontally  and  ver*cally  integrated  plaEorm  with  

global  scale  

§

One  out  of  every  12  prescrip*ons  dispensed  in  the  U.S.  –  

brand  name  or  generic  –  is  a  Mylan  product  

§

A  Fortune  500  company,  with  $6.9B  in  revenue  

(5)

External  World  

§

Health  care  is  becoming  a  

precision-­‐based  industry  

§

Public-­‐  and  private-­‐sector  

integra:on  in  financing  and  

delivery  of  care  

§

Health  care  sector  is  

industrializing  

§

Process-­‐driven  valida:on  

§

Generics  growth  

§

Campaign-­‐driven  

manufacturing  

§

Mix:  volume  balancing  

§

Systems  customiza:on  leads  to  

ever-­‐smaller  groups  requiring  

tailored  treatment  regimes  

§

Expanding  public-­‐  and  private-­‐  

sector  rela:onships  will  create  

a  mul:-­‐trillion  dollar  global  

market  

§

Higher  efficiency  will  enable  

mee:ng  higher  demands  of  

more-­‐informed  customers  

§

Increased  number  of  expiring  

patents  and  generics  growth  

requiring  beUer  planning  and  

refined  manufacturing  and  

business  strategies  

 

(6)

Smart  Plants  –  Loosely-­‐Coupled  Architecture  

Integra2on   Framework  

Integra2on   Framework  

The  new  architecture  loosely  couples  the   plant  opera:ons  from  the  SAP  system  

§  Reduces  risk  of  single  point  of  failure  

§  Provides  the  plants  with  a  flexible  

execu:on  layer  

§  Ability  to  integrate  with  Supply  Chain  and  

SAP  on  an  on-­‐demand  basis  

Global  Supply  Chain  Processes  

•  Demand  Planning   •  Supply  Planning   •  Sourcing  

•  Logis:cs  Execu:on  

Shop  Floor  Opera:ons  

•  Expanded  suite  

•  Func:onality  flexed  by   plant    

•  Review  by  excep:on   •  Frequent  batch  updates  to  

SAP  layer  

SAP  ERP  Layer  

GSCM  Layer  

Manufacturing  Layer  

Global  Transac:onal  Processes  

•  Commercial/Order-­‐to-­‐Cash  process   •  Finance  Transforma:on  

•  Local  Addi:ons  

Plant  Automa:on  Layer  

Localized  Processes  

•  SCADA/PLC/DCS   •  Barcode  

•  Weight  

(7)

Smart  Plants  –  Ideal  State  Process  View  

Equipment Plant Management Global Demand and Supply Planning

Plan  and  Source  

Produce  

Test  

Manufacturing Execution System Supplier Management MRP & Production Planning Plant Maintenance Serialization Equipment Automation and Data Historian Lab Information Management System Data Acquisition Quality, Reg, Training

Management Management Document

CAPAs / Cust Complaints / Change Control Label Artwork Management Incident Management EHS Management Process Control Building Management System Calibration ERP

(8)

Smart  Plants  –  Future  State    

Business  

architecture  

Plants,  with  processes  and  systems  that  are  standard  and  consistent  by   plant  type,  supported  by  global  governance

§  Global  and  coordinated  approach  to  deploying  capabili:es  

Capabili:es  and  

informa:on  

Access  to  informa:on  throughout  the  plant  

§  Seamless  informa:on  flows  within  and  across  plants,  supported  by  

automated  equipment  

§  Data  visibility  from  shop  floor  

§  Automated  KPIs  and  analy:cs  

Increased  quality/reduced  risk  through  standardiza:on  and  automa:on   across  plants  

§  Presenta:on  of  workflows  to  operators  and  enforcement  of  tasks  

§  Automated  data  capture  

§  Poten:al  to  include  equipment  automa:on  and  Process  Analy:cal                                                    

Technologies  (PAT)  

Faster  ability  to  integrate  M&A  and  stand  up  new  plants,  due  to  standard   systems/processes  

Applica:ons  &  

technology  

Global  SAP  plaPorm  

Manufacturing  Execu:on  System,  including  

§  EBR,  data  historian  and  automa:on  layer  

Integra:on  of  systems    

(9)

Pharma  Manufacturing  Best  Prac2ces  

§ 

G  x  P  compliance  

§ 

FDA  21  CFR  Part  11  compliance  

§ 

Automated  large-­‐scale  data  collec*on  using  direct  

equipment  interfaces  

§ 

Track  and  trace  

§ 

High  up:me  and  asset  u:liza:on  

§ 

Predictability  of  schedule/quality/yield  

§ 

Provide  visibility  to  product  cost  drivers  at  a  granular  level  

§ 

Predic:ve  maintenance  to  improve  OEE  management  

§ 

Master  data  granularity  and  accuracy    

§ 

Manage  valida:on  requirements  

(10)

Impera2ves  

§

Leverage  plant  automa:on  with  considera*on  to  geography,  plant  

configura*on,  ROI  and  talent  

§

High  availability  24x7  &  reduced  dependency  on  ERP  up:me  

§

Self  contained  (Historian)  

§

Capacity  and  schedule  visibility  to  maximize  schedule  adherence  

§

Core  templates  for  family  of  products  and  leverage/enhance  to  meet  

localized  plant  needs    

§

Full  compliance  to  serializa*on  mandates  and  leverage  the  data  

across  the  extended  supply  chain  

§

Data  capture  focused  towards  process  compliance  

§

Electronic  Batch  records  

§

Integrate  and  consolidate  data  collec:on  and  retrieval  across  

systems  (SAP-­‐QM,  LIMS,  TrackWise,  Minitab  and  Documentum)  

(11)

Efficient  Manufacturing  Opera2ons  

Integrated  Manufacturing  Opera:ons  enable…  

§  Complete  visibility  and  higher  efficiency  across  the  

opera*onal  con*nuum  

§  Reducing  total  and  unit  manufacturing  costs  

consistently  to  meet  customer  requirements  

§  Ensure  compliance  with  quality  and  safety  standards  

   

Visibility  to  manufacturing   opera2ons  across  the   organiza2on  to  help  adapt   quickly  to  changes  in  customer   orders  and  consistently  deliver   on  commitments  

Integra2on  and  synch  plant   produc2on  opera2ons  with   enterprise  plan  for  higher   efficiency  while  cuQng  

Integrated  manufacturing  controls   with  industry  processes  and  

(12)

Future  State:  Smart  Plant  

Master  Data  

Master  Recipe  

Opera2ons  

Shop  Floor  

Plant  Control  Des:na:on  

SCALE  

PLC  

SCADA  

MES  

PP-­‐PI  SHEET  

HISTORIAN  

OPERATOR  

LAB   INFORMATICS  

EBR  

CONFIRMATIONS  

Scheduling  &  

Sequencing  

Process  sheets  used  to  

collect  floor  data  

directly  to  ERP  

 

Recipes  are  separated  

for  each  stage  

Weigh  &  

(13)

Comprehensive  Integra2on  Business  Strategy  

§  Unified  Enterprise  Plaaorms  for  AI/B2B  and  MDM/DI  

Plaaorms  

§  Enable  interoperability  and  seamless,  loosely  coupled,  

agile,  reusable,  adaptable  applica:on  and  data  integra:on  

§  Enable  service-­‐oriented  approach  to  integra:on  

§  Enable  source-­‐agnos:c,  simplified  integra:on  workflows  

§  Common  plaaorm  that  evolves  with  Mylan’s  unmet  and  

unknown  data  needs  

§  Master  data  driving  “golden  profiles”  that  are  consumed  

by  front  office  and  back  office  applica:ons  and  deployed   to  business  processes    

§  Enable  informa:on  and  data  governance  –  aids  in  

effec:ve  stewardship  

Integra:on  Founda:on  (IF)  PlaPorm  Scope  Include:  

§  Applica:ons  Integra:on  (AI)  and  B2B  

§  Master  Data  Management  (MDM)  and  Data  Integra:on  (DI)  

PlaPorm  Strategic  Themes:  

PlaPorm  /  Founda:on  approach  vs.  Applica:on  approach  –  Implement  the  

Technical  Capabili:es  to  support  future  Business  Capabili:es  

Se rv ice s   In te gr a: on  

Reac:ve  

Proac:ve  

(14)

Coupled  With  a  Robust  KPI/Analy2cs  Program  

BI  Capabili:es  

Business  Capabili:es  

§  Key  Performance  Indicators  

§  List  

§  List  

§  List  

§  Key  Business  Drivers  

§  List   §  List   §  List     §  Key  Metrics/Processes   §  List   §  List   §  List  

BI

Enablement

Informa2on  Supply   Informa2on  Management   Informa2on  Delivery   Informa2on  Landscape   People Process Technology Supply Chain Analytics

HR Analytics Commercial Forecasting Commercial Analytics Customer Analytics Management Reporting Churn Analytics Quality Analytics

Self Service Analytics Integrated Planning Single View of Customer Single View of Product

Management Reporting Man ag em en t  Re po r: ng  

(15)

Smart  Plant  -­‐  Solu2on  Architecture  

                     

SAP  Business  Suite  

 

Single  source  of  truth  for  master  data  and  transac2ons    

MES  

MBR  Management   Equipment  management   Weigh  &  Dispense  

Manufacturing  &  Packaging   Execu2on  and    EBR  

Review  by  Excep2on  

Document   Managment  system   SOP   Training  Management     Opera2onal     Intelligence   LIMS   Laboratory   Management   Labeling   System  

Data  Acquisi2on  Systems/Historians  

SCADA/PLC  /DCS     Barcode  System   Weighing  Scale  

Produc2on  Data  and   Analy2cs     CAPA  

                         

SAP  SCM  Suite  

       SNOP,  DP,  SNP,  GATP,  PPDS,…  

(16)

Summary:    Business  Benefits  

§

Ability  to  scale  and  respond  nimbly  to  changes  in  demand,  

regulatory,  produc*on  requirements  

§

Reduce  process  cycle  :me  and  increase  inventory  visibility  

§

Ability  to  understand  plant  efficiency  and  equipment  

effec:veness  

§

Increase  right  first  :me  batches  

§

Ability  to  onboard  new  sites  /  lines  in  an  automated  fashion  

§

Reduce  risk  of  human  error  in  data  collec*on,  compliance  

and  process  instruc*ons  

(17)

Thank  You!  

For  addi*onal  informa*on,  please  contact  us  at  

[email protected]  or  visit  us  at  

www.intrigosys.com.  

References

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