TQS PAT Presentation - ISA

PI,
DATA Integration Platform
for
PAT & UMetrics
Pharmatex 2007
Cork, Ireland
1

Introduction
� Introduction to TQS & OSISoft
� 5 Minutes
� Data Infrastructure using PI for PAT Anaysis.
� 10 Minutes.
� Focus on uMetrics Suite
� 10 Minutes.
� Questions & Answers
� 5+ Minutes.
2

TQS Integration Ltd. – Who are we ?
� Authorised distributor of OSIsoft products in Ireland
– Founded 1998, Offices in Lismore, Co. Waterford
– Report to OSIsoft GmBH
– Work extensively with OSIsoft in Germany + US in sales & customer
support and implementation of PI.
– Provide services to support the full lifecycle associated with implementing,
operating and leveraging value from the OSIsoft product suite.
� Established Multi-National client base
– TQS has an extensive customer base of leading pharmaceutical
companies and continues to add new customers to that list and expand the
PI installations within it’s existing customer base.
– PI has proven it’s functionality as a core real-time data system and has met
evolving requirements of different customers
3

TQS – Our Team
What we provide ?
� OSISoft Integration
– Corporate & Distributor Partnership
– Unrivalled knowledge of PI product suite.
– OSIsoft certified engineering team.
– Turnkey Integration Project Experience
� Infrastructure
– Cisco Partners
– Extensive experience in Infrastructure Design, Implementation, Project
Management.
� Value Added
– uMetrics
– XMII (SAP)
– Exergetic Systems Inc. (Power Industry)
– MES (Werum, Propaq, Camstar)
– Control System / SCADA (ABB, Emerson, Foxboro, Fix, Intouch, PLC ….etc.)
– LIMS
4

� Allergan
� BESL (ESBI), Spain
� BMS
� Boston Scientific *
� Centocor
� Eli Lilly
TQS – Our Clients
� ESB (Power Generation)
� ESBI (ESB International)
� Janssen
� Merck Sharp & Dohme
� Novartis
� Pfizer
� PPC, Greece
� Roche Ireland
� TYCO
� Wyeth
5

Introduction to OSISoft
“the the Makers of PI”
PI
6

OSISoft – The makers of “PI”
Who are OSIsoft?
� Privately-held & profitable independent company
– Successful. In business for 27 years
� Software Company.
– Focused exclusively on real-time process information management (PIM)
systems – makers of the PI System
– not automation, not MES, not multivariate analysis, but integral to all
– strong partner program for services and applications
– clear business model allows best-in-class approach
� Volume of business (CY2006: $180 million) in PIM systems exceeds all
others combined
– OEM supplier to Emerson, GE, ABB, Rockwell, and Siemens
– In the software business, volume is essential to long-term viability and adaptability.
– Volume is difficult to achieve in the manufacturing software business.
7

OSISoft.
Why PI?
� Data Collection Interfaces
– The PI System has over 400 data collection interfaces
• to most all commercially available process instruments, analyzers, PLC, & DCS
– A typical pharmaceutical site will require at least 10 different interfaces to DCS, standalone
PLC, and PAT instruments.
• Flexible Licensing Arrangements
� Maintainability
– Many of the PI System data collection interfaces are self-configuring and inherit the
database definitions of the underlying control system.
– This is especially important for S88 Batch Recipe. It significantly reduces the cost of
installation, validation, and maintenance.
� Enterprise Integration and Real-time Visibility
– PI RtReports and RtPortal products provide real-time visibility into the manufacturing
process, and bring together all production data from PI, LIMS, MES, & SAP in a specific
and meaningful context.
– PI eliminates all time and distance barriers between people and assets
8

OSIsoft & Pharmaceuticals
� The Pharma story at OSIsoft
– Significant installed base of PI Systems in Pharma
– 200+ PI Systems at Pharma sites
– 9 of the Top 10 have at least 2 Sites with PI Systems
– 16 of the Top 20 Companies have a PI System
– Over 2,000,000 total licensed “tags” in Pharma
– Average PI Server size is 10,000+ tags
9

Top 20 Pharmaceutical Companies
(Based on 2005 pharma revenues, in billions)
Rank Company
2005
Revenues
PI?
1 Pfizer $44.28 YES
2 GlaxoSmithKline $33.96 YES
# of PI
Sites
3 Sanofi-Aventis $32.34 YES 4
4 Novartis $24.96 YES 4
5 AstraZeneca $23.95 No 0
6 J&J $22.32 YES
7 Merck $22.01 YES 18
8 Wyeth $15.32 YES 2
9 Bristol-Myers Squibb $15.25 YES 5
10 Lilly $14.66 YES 10
5
4
6
10

Top 20 Pharmaceutical Companies
(Based on 2005 pharma revenues, in billions)
Rank Company
2005
Revenues
PI?
# of PI
Sites
11 Abbott $13.99 YES 9
12 Roche $12.90 YES 8
13 Amgen $12.02 YES 6
14 Boehringer-Ingelheim $10.84 YES 1
15 Takeda $8.53 No 0
16 Astellas $8.04 No 0
17 Schering-Plough $7.56 YES 1
18 Bayer $7.56 YES 4
19 Schering AG $6.29 No 0
20 Genentech $5.49 YES 3
11

Overview of the PI System
Real-Time Real Real-Time Time Data Infrastructure for PAT
12

PI Real-time Infrastructure
ONE set of Assets in the Enterprise ~ MANY VIEWS
Internet
Product
Empirics
Innovation
Empirics
Stock
Value
Limits
Consistency
Money
Costs
Earnings
Accounting
Process
Engineering
R & D
Quality
Finance
Automation
Reproducibility
Executive
Process
Operation
4288e © Copyright 01/2007 OSI Software GmbH - Company Confidential
Business
KPI
IT
Environment
Purchase
Maintenance
Throughput
Yield
Waste
Availability
Performance
Security
Health
Government
Regulation
Stock
Capacity
Deliveries
Price
Availability
Performance
Security
Portal
Business Data
Organizational Data
Process Data
IT Systems
Collaboration
SOA
SAP PI ProcessBook
13

The “PI Enterprise Infrastructure”
The 3 parts of PI
� The Server
– Data Acquisition / Data Reference
– Key Aspect of PI
� The Analytics
– Data to Information Transformation
– Application of Data Context.
� The Visuals
– Smart Clients
– Thin Clients
• Sharepoint
• Netweaver
14

The PI System
Performance
Improvement
The
Visuals
The
Analytics
The
Server
Structure /
Asset
Data
Operational
Visibility
Deliver Information for Meaningful,
Better Business Decisions
Gathers, Organizes, Distributes,
and Stores Data from Many Sources
Real-Time
Data
Knowledge
Management
Custom
Data
Product
Quality
Lean
Manufacturing
Turn Valuable Real-Time Data
Into Actionable Information
IT Data Relational
Data
Asset
Management
Web
Services
Situational
Awareness
ERP /
Maintenance
15

1. “The Server” – PI Enterprise
Primary Components
16

2. “The Analytics” – PI Enterprise
Primary Components
17

3. “The Visuals” – PI Enterprise
Primary Components
18

Overview of the PI System
Data Integration Strategies
19

PI Infrastructure for PAT.
What will be Discussed !
� Corporate / Site Infrastructure
– Optional Hybrid Approach.
� Data Acquisition / Data Reference.
– Data Acquisition provides significant advantages
� Data Presentation (Visuals)
– What the user sees & What the Engineers use !
– Compliance v’s Management Reporting
� Data Analytics
– Data to Information Transition
– External Systems Linkages (uMetrics)
20

“The Server” – PI Enterprise
Corporate v’s Site Infrastructure.
� Site or Corporate ?
– Site. (PI Server Installed on Plant Site)
– Corporate (Central Server serves Many Sites)
� Site Approach Advantages
– Site has Specific Reporting Requirements
• Daily Management of Processes, Six Sigma ….etc.
• EBR Reporting
– Site may require additional I/O not required @ corporate
– Local “data” understanding, may not be available @ corporate.
– More flexibility on on-line storage
� Corporate Approach Advantages
– (COE) Centre of Excellence Strategy
– Location of Corporate Systems (SAP, LIMS, ….etc.)
– Less “local” expertise required
– Facility for 24/7 Support Structures
� Hybrid Approach has significant advantages
21

Typical #1:: PI Data Infrastructure
Site Centric Approach to Integration.
22

Typical #2:: PI Data Infrastructure
Corporate / COE Hybrid Data Integration
23

“The Server” –
Data Acquisition Acquisition v’s Data Reference
Reference
� Data Acquisition
– Data is Acquired into PI Enterprise Historian
– Data Stored in PI Archives, Module Database, Application framework
– 400+ Standard PI Interfaces Available
• Includes “Standards” OPC, RDBMS, XML …e.t.c.
� Data Reference
– Data is Maintained in Source System, Referenced “through” PI
– Minimises Data Duplication
– Additional Considerations ?
• Underlining Data Structures
• Resolution of Source data
• On-Line timeframe
• Security
24

Data Acquisition Acquisition v’s Data Reference
Reference
Sample Set of Integrated Systems (TQS)
� ABB
– Infi90, Advant, Mod300, Sattline, 800xa, System 6, InformIT
� Emerson
– RS3, ABC Batch, Delta-V (6.x, 7.x, 8.x, 9.x)
� Foxboro
– IA Series
� Honeywell
– Plantscape
� Scada
– GE (Fix, iFix, iHistorian)
– Rockwell (RSView, RSLINK)
– Intouch (Wonderware)
� Others
– IT Systems (NT, Cisco, NT, Unix, HP, UPS, SNMP Compliant devices)
– PLC’s (Siemens, Allen Bradley, Mitsubishi …etc)
– Analyzers (Lazentec, Power Analyzers …etc.)
– LIMS (generally RDBMS, XML or Flat Files)
– SAP (PPPI / PM / QM – OSISoft Certified Links)
– SDMS (Waters)
– Barcode, Pager, ….. Generally limitless list.
25

“The Visuals” Strategy
Compliance Reporting & Management Reporting
� Compliance Reporting (Analysis / Visuals)
– OSISoft
• rtReports from OSISoft
– Others
• RtPortal - Thin Client (based on IIS / Sharepoint)
• RtBusiness Portal – Think Client based on Netweaver (Certified)
� Management Reporting. (Visuals)
– OSISoft.
• rtReports from OSISoft (non-compliant version)
• “Smart Clients” (Processbook, Datalink, Batchview …etc.)(
• “Thin Clients” (Sharpoint, RtPortal, non-Compliant RtReports.
– Others.
• XMII
• uMetrics Suite
• MES Systems – Werum, Propaq, Camstar, Compliance Suite …etc.
• ERP Systems - SAP, Maximo (Certified links from PI)
26

Compliance Compliance Reporting
RtReports
Rule based
Manipulation save
Reproducible
Enterprise Reporting tool
• Supports standardized enterprise
reporting
- Uses templates for repeatable reports and data
retrieval
• Allows you to easily manage change
through versioning
- Report templates are versioned like pieces of
equipment
- Review and Release workflow for report
templates
• Provides report output tracking
- No need to store output
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Management Management Reporting
OSISoft - Smart Clients
Integration of real time data
into your individual
environment
• ProcessBook
• DataLink
• ActiveView
• BatchView
• SQC
4747 © Copyright 01/2007 OSI Software GmbH - Company Confidential
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Management Management Reporting
Thin Clients - RtWebParts - Context - Collaboration
4488a © Copyright 01/2007 OSI Software GmbH - Company Confidential
29

“The Analytics” Strategy
Data Access Strategy to externals
� PI Enterprise Server
– WEB Services (Baseline Service)
– OPC / OPCDA / OPC UA
– Relational Database (SQL Server, Oracle …etc.)
– Application Framework from OSISoft (AF2)
– Any others …. Via ACE !
� Certified Links
– SAP (RLINK)
– Maximo (RLINK)
– RtBusiness Portal
� Standard Interface Methodologies
– uMetrics (Continuous & Batch)
– Exergetic Systems Inc.
30

“The Analytics“
Data Access Strategy to externals
ERP MES
Analysis
SAP, Maximo, JDE
Werum, Propaq,
Camstar, Compliance Suite
SPC
uMetrics
MVA
uMetrics
Connectivity Options presented by PI / Industrial Standards
KPI
XMII /OSIsoft
31

“The Analytics“ - Typical UMetrics Connectivity
SIMCA-Batch On-Line (SBOL)
Analysis Analysis Analysis SBOL
SBOL
Server
SIMAPI
Connectivity Node
PI-API / SDK
Admin. View
SBOL
Internal
Data Storage
SIMCA-P+
Batch Project
32

Summary
(TQS Section of Presentation).
� PI Provides Data infrastructure Layers (facilitates PAT)
– Data Acquisition
– Data Storage
– Data Presentation / Reporting
– Data “sharing” to External System
� TQS provides a “turnkey solution”
– Design, Specification, Implementation,
– Validation
– Training & Engineering Support Functions.
� uMetrics Integration for PAT Analysis
– Introducing uMetrics for MVA Analysis
33

Summary thought
Albert
Albert
Einstein
Einstein
had
had
just
just
administered
administered
an
an
examination
examination
to
to
an
an
advanced
advanced
class
class
of
of
Physics
Physics
students.
students.
As
As
he
he
left
left
the
the
building,
building,
he
he
was
was
followed
followed
out
out
by
by
one
one
of
of
his
his
teaching
teaching
assistants.
assistants.
"Excuse
"Excuse
me,
me,
sir,"
sir,"
said
said
the
the
shy
shy
assistant,
assistant,
not
not
quite
quite
sure
sure
how
how
to
to
tell
tell
the
the
great
great
man
man
about
about
his
his
blunder.
blunder.
"Yes?"
"Yes?"
said
said
Einstein.
Einstein.
"Um,
"Um,
eh,
eh,
it's
it's
about
about
the
the
test
test
you
you
just
just
handed
handed
out."
out."
Einstein
Einstein
waited
waited
patiently.
patiently.
"I'm
"I'm
not
not
sure
sure
that
that
you
you
realize
realize
it,
it,
but
but
this
this
is
is
the
the
same
same
test
test
you
you
gave
gave
out
out
last
last
year.
year.
In
In
fact,
fact,
it's
it's
identical."
identical."
Einstein
Einstein
paused
paused
to
to
think
think
for
for
a
a
moment,
moment,
then
then
said,
said,
"Hmm,
"Hmm,
yes,
yes,
it
it
is
is
the
the
same
same
test."
test."
The
The
teaching
teaching
assistant
assistant
was
was
now
now
very
very
agitated.
agitated.
"What
"What
should
should
we
we
do,
do,
sir?"
sir?"
A
A
slow
slow
smile
smile
spread
spread
over
over
Einstein's
Einstein's
face.
face.
"I
"I
don't
don't
think
think
we
we
need
need
do
do
anything.
anything.
The
The
answers
answers
have
have
changed."
changed."
And
And
just
just
as
as
the
the
answers
answers
in
in
Physics
Physics
change,
change,
so,
so,
too,
too,
do
do
the
the
answers
answers
to
to
your
your
problems
problems
change.
change.
While
While
to
to
all
all
appearances
appearances
you
you
may
may
have
have
the
the
same
same
tests
tests
given
given
to
to
you
you
by
by
life,
life,
the
the
same
same
recurring
recurring
problem,
problem,
consider
consider
the
the
possibility
possibility
that
that
the
the
person
person
contemplating
contemplating
the
the
problem
problem
has
has
changed.
changed.
Time
Time
has
has
passed;
passed;
you've
you've
learned
learned
many
many
things
things
along
along
the
the
way.
way.
Rather
Rather
than
than
keep
keep
on
on
trying
trying
to
to
force
force
the
the
same
same
old
old
solutions
solutions
which
which
didn't
didn't
work
work
before,
before,
it
it
might
might
be
be
time
time
to
to
try
try
something
something
else,
else,
something
something
that
that
emerges
emerges
from
from
the
the
new
new
person
person
that
that
you've
you've
become.
become.
The
The
tests
tests
may
may
be
be
the
the
same,
same,
but
but
the
the
answers
answers
have
have
changed.
changed.
PAT
PAT
Process
Process
Knowledge
Knowledge
MVA
MVA
Albert Einstein
34

TQS – Thanks
35