Exploring the Features New Instrument Enterprise Edition...Independent Consultant – GSK Advair Project Core Team Tanvec (now Bovis) – Senior Scientific Consultant Hewlett-Packard

Exploring Benefits of Enterprise Edition

Services Enterprise Edition ComplianceAgilent Restricted

Nov 9th 2007Page 1

Exploring the Features& Benefits of Agilent’s

New InstrumentQualification Program –

Enterprise Edition

Agilent Services Group

Paul Coombes

Senior Consultant Compliance Services

December 4th & 6th 2007

Services Enterprise EditionAgilent Restricted

Nov 9th 2007Page 2

Paul Coombes

Professional Background

Agilent – Senior Consultant Compliance Services

Washington Group International – Director of

Validation Services (Eastern Hemisphere)

Independent Consultant – GSK Advair Project Core Team

Tanvec (now Bovis) – Senior Scientific Consultant

Hewlett-Packard Analytical (now Agilent)

Eli Lilly

Author: Laboratory Systems Validation Testing & Practice 2002 PDA/DHI

Consultancy Jobs: Process Validation, Lab Validation, IT Quality, Computer SystemValidation, Corporate QA: forGSK, Merck, GW, SKB, B-I, Ferring, J&J, Cilag, Centocor, Janssen, Baxter, Lilly, Chiesi et al

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Nov 9th 2007Page 3

Attendees Objectives

Understand what Agilent’s Compliance Servicesoffer and do not offer

Appreciate why we upgraded the IQ & OQsystem

Discover the key features of Enterprise Edition

Hear what Enterprise Edition has already givencustomers

Ask questions


Nov 9th 2007Page 4

Agenda

Part I

Overview of Agilent’s position in the world of lab validation

Four main drivers for change

Keywords / Buzzwords:

ACE, AIQ, CDS, CSV, EMEA, EQP, EQR, FDA, GAMP, GC, GCP, GLP,GMP, harmonization, in-house, IQ, LC, LCMS, outsource, OQ, PDF, RQ,SOP, streamline, USP.

Part II

Describe the new qualification system

Part III

Hear some customer experiences

Q&A - Close @ 60mins

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Nov 9th 2007Page 5

What does Agilent offer in the wideworld of Compliance Services?

• Financial reports & accountancy auditing &Sarbanes-Oxley : NO

• Process validation: NO

• Process equipment validation & calibration: NO

Many ‘Compliance services’ found in Pharmaceutical business


Nov 9th 2007Page 6

What does Agilent offer in the wideworld of Compliance Services?

Method Validation: SOME

• Agilent applications chemists can contribute to your methodvalidation/transfer project. Custom service in Agilent labs.

Computer system validation (CSV): SOME

• Planned Installation and Software IQ & OQ contributes to your CSV projecton Agilent software.

Analytical Instrument Qualification (AIQ): YES

• Full, end-to-end solution.

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Nov 9th 2007Page 7

Where is Agilent in AIQ?

Well over 100,000 qualifications delivered. No FDA warnings.

Industry in US & Europe recognize Agilent as the leader

• Voted clear #1 provider of Instrument Qualification by Managers & Decision-makers this year and in 3 out of 3 surveys *

In 1999, 2004 and 2007 blind surveys.Independent results were compiled by AdvanstarCommunications Market Research.


Nov 9th 2007Page 8

Why Has Agilent upgraded itsCompliance Services?

Four main drivers to change

1. Complex landscape of Chromatography data systems (CDS)

• Agilent has ChemStation, Cerity, EZChrom, OpenLab and LCMS/GCMSsoftware.

• Our customers also use Atlas, Chromeleon, ClassVP, Empower, Galaxy,TotalChrom and many others.

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Nov 9th 2007Page 9


2. Customers demanded thatAgilent performs the LC andGC qualification using thecustomers’ own CDS

Customers demanded thesame OQ on their non-Agilentinstruments.

‘Multi-vendor compliance’


Nov 9th 2007Page 10


3. Changes in LC and LCMS usage in the industry.

4. One-size, fixed OQ protocol does not fit all needs.

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Nov 9th 2007Page 11

Good In-houseprogram with self

deliveryClassic Edition

OQPVEnterprise Edition

OQ

Listof

Characteristics

What aspects have been upgraded? Acomparison table …

SOP: Qualification of HPLCPharma Firm ABC Site XYZ

• Intro

• Overview

• Tests

• Forms

• Deviation procedures

• Appendices

Opinion based onexperience

Yes / No Yes / No


Nov 9th 2007Page 12

YesNoYesCompatible with all Agilent CDS and most non-Agilent CDS (e.g. OpenLab, EZChrom, Empower)

YesYesYesCompatible with ChemStation CDS

YesNoYesCompatible with most non-Agilent LC and GCinstruments

YesYesYesCompatible with Agilent LC and GC instruments

YesYesYesApprovable to a risk-conscious QA Department

MostlyYesYesAcceptable to International Agency auditors

YesYesYesMeets the letter & intentions of GMP and GLP

Good In-housemodel

Classic EditionOQPV

EnterpriseEdition OQ

Characteristic


• Intro

• Overview

• Tests

• Forms


• Appendices

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Nov 9th 2007Page 13

NoNoYesReports with searchable electronic data & results

NoNoYesFinal report in secure pdf with single signature

NoYesYesComprehensive final report with automated resultscalculation and pass/fail status reporting

YesNoYesProvides customer selectable tests then a fixedprotocol containing these tests & limits

Not alwaysYesYesProtocol with fixed recommended tests & limitswith commercial standards of robustness

Some overtest

YesYesAdequate for compliance without delivering “over-testing”

Good In-housemodel

Classic EditionOQPV

EnterpriseEdition OQ

Characteristic


• Intro

• Overview

• Tests

• Forms


• Appendices


Nov 9th 2007Page 14

Future of the new qualification system

“Enterprise Edition is Agilent’s new platform forequipment qualification, and is ready to replace the

classic OQ/PV …”

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Nov 9th 2007Page 15

Ángel Martin. Marketing Product Manager

Transcript of voice message:

“Hello, this is Ángel Martin, Marketing Product Manager forcompliance services.

From its introduction about two years ago, Enterprise Edition hasbeen very well accepted by our regulated customers.

We have increased its coverage, its scope - until completing themain chromatography techniques.

Now that portfolio coverage is complete, we are improving theplatform’s reliability and usability, implementing new features for

• a more streamlined delivery and

• further reduction of approval and review times.

With its many advantages to address the regulated industryqualification needs, Enterprise Edition is Agilent’s new platform forequipment qualification, and is ready to replace the classic OQ/PVas our customers decide to move over.

Realizing these benefits, many of Agilent’s regulated customershave already made the switch from the Classic OQ/PV. And weknow that many more will do soon, according to their own globalvalidation policies and schedules.

Thank you very much for your interest in Agilent EnterpriseEdition!

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Nov 9th 2007Page 1

Part IIDescription of the new qualification

system


Nov 9th 2007Page 2

1.Procedure

• Procedures, test scripts, results forms, working instructions, test design,training (material, trainers, certification),

2.Tools

• Metrology tools, reference standards, data reduction & reportgeneration tool (ACE software), record-keeping media (PDF, CD,binder)

3.People

• Agilent Service Engineers – most countries

• Authorized Service Providers (ASP) – some countries

• Back room support – scheduling, technical assistance, training etc.

Enterprise Edition compliance service comprises

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Nov 9th 2007Page 3

Wolfgang Winter. R&D Manager Compliance Services


“Hello this is Wolfgang Winter. With Agilent Technologies inWaldbronn, Germany. I’m the R&D Manager for Instrument andCompliance Services.

I have the privilege of managing an international team of veryexperienced and talented services development engineers andproject managers.

We determine what can be tested, and what must be tested on aninstrument, to verify that it conforms to specifications. We buildthe automation & evaluation software tools for efficient andconsistent delivery worldwide by our service technicians.

The Agilent Compliance Engine - is our flagship product. Weapply the rigor of our Agilent development lifecycle to servicesdevelopment - to the same standard as the other divisions.

We have traceability from requirements to test results. And, ourfield service engineers use properly qualified delivery systems.

Therefore our customers can be assured that Agilent ComplianceEngine is a commercial off the shelf software product validated &tested by Agilent.”


Nov 9th 2007Page 4

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Nov 9th 2007Page 5

Brian ChapinWorld-Wide Support Engineering Manager


Nov 9th 2007Page 6

Brian Chapin. World-Wide Support Engineering Manager


“Hello everyone. Thank you for participating in today’s seminar.

Agilent holds the enviable position as #1 in Compliance, not only becauseof the compliance products we’ve developed, but because we take thewhole process seriously.

We continually invest in keeping our staff and authorized service providersup to date with the latest software, methods and best practices. Hundredsof service professionals from around the world have already gone throughour rigorous training and certification program, and hundreds more willsoon follow. All of them are required to take regular update training tocontinue delivering compliance for our customers.

Even the test equipment they use is subjected to regular calibration andtesting. If anything is damaged or out spec, we have a thorough process toverify that it meets our high standards before it can be used again.

I’m holding a binder that was recently added to our Enterprise Editioncompliance program. Each instrument will have a unique binder in whichwe place all the compliance documents and reports. It’s designed to holdat least 9 years of IQ, OQ and RQ records, in a format that makes it easyfor our Engineers to provide consistent, reliable and professional resultsover the years.

Customers love it because they have the documentation they need at theirfingertips. No hassles. No ‘do it yourself’ anxiety. No concerns about labstaff turnover.

Simply put, our customers can focus on running their labs while Agilent’sprofessionals take care of their compliance.

Thanks for listening, and have a good day.”

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Nov 9th 2007Page 7

The final deliverable of the service to you, is theEquipment Qualification Report (EQR) and Binder


Nov 9th 2007Page 8

Design of Enterprise Edition system

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Nov 9th 2007Page 9

EQP

EQPs are alsodownloadable from web.

Feb2008: interactiveweb site with all the CDcontents

Example reports, checklists, certificates, videos


Nov 9th 2007Page 10

EQPEQP

ACE

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Nov 9th 2007Page 12

Global_EQP_LC

CustomerConfigured EQP

PHARMA_EQP_001

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Nov 9th 2007Page 13

Summary Design of Enterprise Edition

EQP

ACE

Review CD

ISO CD

HPLC

123

EQR for each system


Nov 9th 2007Page 14

The Equipment Qualification Report

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Reviewing the Equipment Qualification Report

5 >

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The Equipment Qualification Report in Detail


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Nov 9th 2007Page 31

Interactively view the raw data chromatography files


Nov 9th 2007Page 32

use cursorto zoom

double-click


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Nov 9th 2007Page 33

For more info & to download the AIA utility from the web click:

http://www.scisw.com/_vti_bin/shtml.exe/products/aia_fileviewer/index.htm

Or Google™ search > AIA viewer

This software utility is designed to providea graphic application to all AIAchromatography data files (the so-called"net.cdf") files defined by the AnalyticalInstrument Association.



Nov 9th 2007Page 34

Data transfer methods

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Nov 9th 2007Page 36

Final Report Approval – Ink Signed

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Nov 9th 2007Page 37

Keep the Records in Binder and/or ElectronicData System


Nov 9th 2007Page 38

Finally, a quick example of the benefits of a singleautomated OQ with searchable electronic records

New design for Gradient Pump

performance testing

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Nov 9th 2007Page 39

Gradient Pump performance and delay volume comparisonacross multiple LC systems


Nov 9th 2007Page 40

End of Part II

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Nov 9th 2007Page 1

Part III

Let’s hear some customer experiences so far inUS & Europe.

Then summarize and move to Q&A …


Nov 9th 2007Page 2

Joachim Werner.Sales Manager in Switzerland.


“Thank you Paul.

Greetings from Switzerland – you probably know it is one of the centres ofpharmaceutical research and manufacture in the world. So, compliance ingeneral and specifically instrument qualification is of major interest formany of our customers.

What I can say is: We have a number of customers who have adoptedEnterprise Edition in Switzerland.

One of our bigger accounts is with a global top 10 pharmaceutical firm. Attheir headquarters and main manufacturing site we introduced EnterpriseEdition for their HPLCs.

They were able to harmonize their previous mix of custom-made tests intoone automated protocol using the Enterprise Edition. The same will soonbe implemented for their GCs.

Other Swiss firms have consolidated their HPLC & GC compliance intoEnterprise Edition and are now looking to roll-out the same program intotheir other subsidiary sites around the world.

They clearly saw the benefits of this technology for their organization as awhole. And the technology has become there, a tool to drive continuousimprovement.”

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Nov 9th 2007Page 3

Eddie Enright.Delivery Manager in Ireland.


“Hi this is Eddie Enright, Support Delivery Manager here inIreland. We are home to manufacturing sites for many of theworld’s largest drug firms.

We have many customers of Enterprise Edition here in Ireland.One of our bigger accounts is with a global top 5pharmaceutical firm, headquartered in UK.

Their experience is typical, they’ve told us:

“The protocol passed all corporate quality levels and nationalagency audit”,

“internal audits were also speeded up”,

“the one harmonized compliance protocol for all labs speedsup report reviews for operators

and caused free-up of lab resources for sample handling.”


Nov 9th 2007Page 4

Brent SalimanNew Services World-wide. Corporate US Office.


“Hello Paul, thank you for this opportunity to share my experience…

In my role I visit customers to understand their current feelings aboutAgilent Services and ask about their additional service needs.

Let me share with you what the Compliance Manager, a Sr. PhDChemist, at one of the larger sites in the US told me recently aboutthe benefits she is receiving from their switch to Agilent’s EnterpriseEdition solution.

According to her, the unified protocol and paperless, searchable reportfeatures have enabled her to reduce routine OQ review time by 80%.

What used to take 2 to 3 hrs per report now takes her less than 30minutes. She was very excited to share with me that, because of thiscompliance solution, she has freed up 10% of her time fromadministrative tasks…time she is now spending in the lab on valueadded testing activities.

This kind of statement validates our design and value proposition forEnterprise Edition. Combined with Agilent’s full service offeringseven bigger savings were reported for this customer.”

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Nov 9th 2007Page 5

Summary

1. Agilent’s Compliance Services offer a full Analytical InstrumentQualification solution suitable for GLP and GMP regulated labs.

2. The upgraded IQ & OQ system was required: [1] to run on all CDS[2] to provide same qualification for non-Agilent systems [3] tomeet changes in LC & LCMS usage [4] to provide tailored protocol.

3. Key features: [1] pdf report – time saving review [2] Binder & CD –professional deliverable [3] single source / single system –harmonization & streamlining.

4. Enterprise Edition has already given customers in North Americaand Europe time & cost savings – and compliance. It will replacethe old OQPV for all new instruments.

5. Enterprise Edition offers risk-free improvement to your instrumentqualification program.


Nov 9th 2007Page 6

Thank you for your time…

www.chem.agilent.com > services

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Nov 9th 2007Page 7

Let’s check my screen for any questions…

How does…? Why is… ? When will…?

Questions answered ‘live’ …

– remaining will be answered by email:

Send to [email protected]

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Documents

Exploring the Features New Instrument Enterprise Edition...Independent Consultant – GSK Advair Project Core Team Tanvec (now Bovis) – Senior Scientific Consultant Hewlett-Packard