ChemStore future 2 - Chemical Analysis, Life Sciences, … future of ChemStore isChemStore is…...

The future of ChemStore isChemStore is…

…OpenLAB!

Christoph Nickel Industry Marketing Manager Life Science

Bernhard EtrichChemStore Program Manager

Informatics and Software SolutionsManager

ChemStore future directionAgilent Restricted

April 11th, 2008

Agenda

• Welcome and Introduction Stephen D.Brown

Future of ChemStore is OpenLAB Ch i t h Ni k l• Future of ChemStore is OpenLAB Christoph Nickel

• ChemStore Roadmap Bernhard Etrich

• ChemStation/OpenLAB benefits Christoph Nickel

• ChemStore Database Migration Bernhard Etrich

• Promotional offer Stephen D. Brown

• Questions and Answers


April 11th, 2008

THE FUTURE OF CHEMSTORE IS OPENLABIS OPENLAB


April 11th, 2008

ChemStore Situation

Standalone and C/S add-on Architectural and programming Standalone and C/S add on database for ChemStation data

Designed as bridge to future

g gstandards from late 90’s

Mandatory link to ChemStation g gAgilent CDS

Robust, mature application

Revision upgrades

Not scalable to large (>90 i t t > 30 )

>550 systems sold with >8000 clients

instruments, > 30 users) installations

Difficult to use (continuousFully featured for regulated Pharma

Difficult to use (continuous switches ChemStation <->ChemStore)


April 11th, 2008

•Different instrument

Customer situation and Agilent OpenLABInstruments Different instrument

techniques from multiple vendors

•Content from many

Instruments

GCGC/MS

•Content from many different sources in different formats

CE

LCLC/MS

ICP-MS

UV-vis

•Processes

•Regulatory needs

R d IT t

The answerContent

•Reduce IT costs

•Increase throughputImagesMS Office

LegacyData OpenLAB: Multi-vendor,

multi-instrument data

PDF DrawingsResearch

S i

management solution for the complete Lab

LSCA Software and InformaticsAgilent Restricted

Services

The role of OpenLAB EnterpriseContentManager ECM in the integrated lab

Partners,Customers

Electronic Notebook

ProjectManagementResearch Data

Corporate Records

Central storage

ManufacturingBatch Records Clinical Trials Instrument Data, Lab Reports

Validation PlanSOPs

LIMSCDS

for all data…

…offering…

final analytical cross-application reporting

central raw data management and archiving

…enabling…… and workflow

automation

OpenLAB BPMAgilent Restricted

October 29, 2008

management and archiving automation……for the paperless lab!

Future direction for ChemStation Plus –ChemStation/OpenLAB EnterpriseContentManager ECMThe situation:

With ChemStation Rev.B.04.01 ECM as data backend will provide superior usability, full compliance, and more powerful functionality for ChemStation:

Better workflow support for improved efficiency

More flexibility – unlimited number of users on multiple sites

Reduced IT costs through easier user administration and less software applications to support (GC-MS Sec P k UV Vi S P k ICP MS )Pack, UV- Vis Sec Pack, ICP-MS…)

Improved compliance (user privileges, data integrity) Situation todayAgilent recommendation


April 11th, 2008

Full suite of migration services available

What if I do not want to move now?

R l !Relax!

Upgrade to ChemStore B.04.01 to support B.04.01 ChemStation

Regular ChemStore Service Releases keep compatibility with new OS, DB and future ChemStation

New functionality might not be available withbe available with ChemStore

But plan for the future!


April 11th, 2008

the future!

ChemStore Roadmap

Bernhard EtrichChemStore Program Manager November 2008

ChemStore Roadmap

2009 2010 2011 2012 2013 2014 2015

May 2011

Service Packs for

Transition periodMay 2011Obsolescenceof ChemStore Server

January 2015Service Packs forRev. B.04.01 server

On-going Service Packs to continue Oracle compatibility

January 2015End of supportof ChemStore server

January 2009Client Rev. B.04.02

SP 1

Support of:Microsoft Vista and XP SP3

On-going Service Packs to continue ChemStation compatibility

SP 2 SP 3

SP1 for Client Rev. B.04.01

January 2014Rev. B.04.01E d f t

SP2 for Client Rev. B.04.01

Microsoft Vista and XP SP3ChemStation B.04.01

ChemStation compatibility

End of support

November, 2008

ChemStore Roadmap

CHEMSTATION/OPENLAB ECMCHEMSTATION/OPENLAB ECM BENEFITS


April 11th, 2008

ChemStation B.04.01 – Get more out of your ChemStation!ChemStation!

More means:• Seamless fit from non-regulated toSeamless fit from non regulated to

strictly regulated environments• Enhanced Workflow support• Better usability & faster results review Additional Benefits:• Better usability & faster results review

• New custom fields for custom data per sample / compound

• Save manual integration in data files• New signal overlay (incl. OpenLAB

ECM data)• Partial acquisition sequence

OO

• Improved OpenLAB ECM integration• Central data management & user

administration (OpenLAB ECM)

Manual Integration Demo

OpenLA

B

OpenLA

B

EC

ME

CM

ChemStation B.04.01Agilent Confidential

May 2008

ChemStation B.04.01 Add-on Modules – Add the Functionality according to your needsFunctionality according to your needs

ChemStation B.04.01 with :a)a) ChemLaunchChemLaunch

b)b) OpenLAB ECMOpenLAB ECM

c)c) OpenLAB Intelligence ReporterOpenLAB Intelligence Reporter

idprovides:• Lab-wide remote instrument management (a)

• Reduce validation & upgrade costs [terminal server] (a)

C t l M t M th d M t (b)• Central Master Method Management (b)

• Improved configurable compliance (b)

• Improved method & result traceability / audit trails (b)

• Configurable access security (b)• Configurable access security (b)

• Cross-sequence report with advanced calculations (c)

Further demo videos on the web:


May 2008

OLIR Demo on Agilent.com ChemLaunch Demo coming soon

What’s New in ChemStation B.04.01?General Functionality R l t C liGeneral Functionality• Save manual integration in data files

• Signal overlay (incl. ECM data)

Regulatory Compliance• Mandatory log-in/connection to ECM

• Session Lock• Partial acquisition sequence

• E-methods for GC ChemStation

• Improved ECM workflow*

• Granular ChemStation user roles and privileges*

• Method audit trail functionality• Improved ECM workflow

Advanced Reporting• Custom fields

• Method audit trail functionality

• Results audit trail*

• All features are configurable*(sample- and compound-related)

Hardware Support• New 1200 Well plate sampler

Infrastructure• New Installation

Wi d Vi t• New 1200 Well-plate sampler

• New 1200 VWD • Windows Vista

• ChemLaunch (Citrix Terminal Server)

* Not available with ChemStation/ChemStore


May 2008

Not available with ChemStation/ChemStore

ChemStore versus OpenLAB ECM data management

ChemStation/OpenLAB ECM Pro:•Full scalability ChemStation (B.03.02)

/ChemStore (B 03 03 SR 2)•Easier administration (NT domain, SQL or Oracle)

•Manages also GC-MS, ICP-MS

/ChemStore (B.03.03. SR 2) Pro:

•Well-established system M

g ,and other instrument records

•Better workflow supportM h i li

•Mature•Tight integration of ChemStation/ChemStore

•More comprehensive compliance functionality

•Digital signature for reports

•Built-in reporting module•Feature-complete for regulated Pharma

•Supports new relational database reporting add-on OLIR

•Future proven

Pharma•Future safe


April 11th, 2008

Future proven

Why replace ChemStore with OpenLAB ECM?

• Functionality in ChemStation/OpenLAB ECM superior to ChemStation/ChemStore

• OpenLAB provides a comprehensive answer to data management needs in today’s laboratories

• Better Reporting with OLIR

• Future-proven investment:Future proven investment:• OpenLAB ECM OpenLAB ECM provides a modern, web-based, fully

scalable architecture• OpenLAB ECM will become data management back-end for all Agilent

(ChemStation family, MassHunter) data systems• OpenLAB ECM will be the back-bone of Agilent’s future CDSp g


April 11th, 2008

ChemStore Data Migration Service

Bernhard EtrichChemStore Program Manager November 2008

ChemStore Migration ServiceAgilent Technologies

1. The Situation


2. Solution A: Virtualize your server

Pros:• Makes you independent of server hardware upgrades

C t ff ti• Cost effective• Minimal training requirements• Minimal maintenance• Limited validation effort• Limited validation effort

Cons: • Upgrade to the latest ChemStore revision to extent the supportUpgrade to the latest ChemStore revision to extent the support

period• Support risk in case of record retention periods > 5 years• for data review onlyy• validation and training effort for 2 data systems


The Solution B: Migrate ChemStore Data in Agilent OpenLAB ECMAgilent OpenLAB ECM

ChemStore database extraction serviceThe ChemStore database gets rolled out in a flat file systemThe ChemStore database gets rolled out in a flat file systemThe file format changes from proprietary to generic

ChemStation formatData gets uploaded to Open LAB ECMIncludes Compliance Services

Migration is delivered by Agilent’s Professional Services Organization (PSO)Organization (PSO)

• On-site• Remotely (under development)


• At Agilent

The Solution: Migrate ChemStore Data into Agilent OpenLAB ECMOpenLAB ECM

You can turn off a ChemStore C/S database and fulfill the followingYou can turn off a ChemStore C/S database and fulfill the following compliance requirements:

R t ti L t hi f ll d t t d t• Retention: Long-term archive of all raw data, meta data (methods, sequences, batches), results and approvals (e-signatures, audit trails)

• Protection: User restricted access to legacy data in ECM• Documentation: Review of chromatograms, results and audit

trail


The Product: ChemStore Data Migration Service

The Data Migration Service is delivered by Agilent’s Professional Services Organization (PSO):g ( )

1. Extraction from ChemStore– PSO will analyze and extract your database

Migrate your database with the ChemStore Data Migration Service!!

2. Import into Agilent Open LAB ECM– Extracted data will be PSOExtracted data will be

imported into OpenLAB ECM3. Agilent validation protocol available after successful migration

PSO

4. Result review with ACAML Viewer, reprocessing in ChemStation


Your Benefits

• You have all your data in one repository (Agilent Open LAB ECM)

• Future proven review of chromatograms, results and e-signatures

• Smooth integration into onesolution for the whole laboratorylaboratory

• Switch off ChemStore server(s)


Summary: Why ChemStation with OpenLAB?

Better compliance, more efficient lab operations at lower costs

Fully scalable from workgroup to enterprise

System transfer is easy and non-disruptive

Full data migration service for ChemStore data into Agilent Unified XMLFull data migration service for ChemStore data into Agilent Unified XML format (ACAML) for review and reprocessing available

Start making your future plans NOW to keep ahead of the curve!


April 11th, 2008

g y p p

Details about ChemStation add-on modules

Details about ChemStore migration

Detailed compliance comparison ChemStation/ChemStore

BACKUP SLIDESDetailed compliance comparison ChemStation/ChemStore –ChemStation/OpenLAB ECM

BACKUP SLIDES


DETAILS ABOUT CHEMChemLaunch and OpenLAB Intelligence Reporter

DETAILS ABOUT CHEM STATION ADD-ON MODULES


April 11th, 2008

ChemLaunch Add-on Module – Drive Down IT and Validation CostsValidation Costs

Increase efficiency with:• remote instrument access • central instrument control • use of ChemStation thin clients

(terminal server environment)

Benefits:• Run ChemStation in a Web Browser• Reduce validation costs• Reduce Lab downtime while upgrading • Reduce IT support costs• More efficient instrument usage• Simplified lab administration

Price estimate : 35 K$ incl installation validation training and SMA excluding ChemStation upgrades

• Simplified lab administration• Enable use of Mac or Linux clients • Fully supported by Agilent


May 2008

Price estimate : 35 K$ incl installation, validation, training and SMA – excluding ChemStation upgrades –IQ/OQ for 10 ChemStation is ~32 k$ for 15 instrument sessions

OpenLab Intelligence Reporter – Get Results Fast!

Fast and efficient with:• Reporting database in ECM• Simple and advanced calculations cross

and within sequence• Interactive report elements and content

based result presentation

Benefits:• Faster from acquisition to final report• Typical Pharma and other reports

• Trend charting

right from the CDS• Lab-wide asset reporting (instruments,

columns,…)I d t lit & li• Improved report quality & compliance

• Access to all results in reporting database through built-in views

• Supports Oracle and MS SQL Server


May 2008

Price estimate : 6K $ (system with 15 ChemStations)

Supports Oracle and MS SQL Server

DETAILED COMPLIANCEChemStation/ChemStore versus ChemStation/OpenLAB ECM

DETAILED COMPLIANCE FEATURE COMPARISON


April 11th, 2008

21 CFR Part11 Requirements –Feature ComparisonFeature Comparison

Feature ChemStation Plus(with Security Pack)

ChemStation B.03.01 SR1(with ECM)

ChemStationB.04.01

(with ECM)Method & Result versioning Yes 1) Yes 3) Yes

Detailed method audit trail N/A 2) No YesYesManual integration audit trail Yes No Yes

Time based session lock Yes No Yes

User roles management Yes No Yes

User authentication Yes Only for ECM login Yesy g

Signing results (approve/reject) Yes Yes (in ECM) Yes (in ECM)

Locking data Yes Yes (in ECM) Yes (in ECM)

Copying data in human readable Yes ChemStation PDF ChemStation PDF format report report

1) Automatic Upload after any kind of result creation

2) Rudimentary method audit trail that requires SOP: Method Change HistoryAll methods are stored with the results and methods are viewable in ChemStore


April 11th, 2008

3) Automatic upload after acquisition and sequence reprocessing

21 CFR Part11 Requirements –Feature ComparisonFeature Comparison

Feature ChemStation Plus(with Security Pack)

ChemStation B.03.01 SR1(with ECM)

ChemStationB.04.01

(with ECM)Compliance for other data in Lab x Yes Yes

Complete Record security Yes Yes

Computer generated, unalterable Yes Yesaudit trail of all system acitiviesCentral data management: Store and organize data from multiple ChemStation installations in one central repository

Yes Yes Yes

Restrict access to ChemStation data stored in Yes Yes YesDatabase based on access rights

Yes Yes Yes

Restrict access to reports stored in Database based on access rights

No reports present Yes Yes

Securely store ChemStation data in Database under revision-control

Yes Yes Yes

Securely store reports in Database under revision-control

No reports present Yes Yes


April 11th, 2008

BACKUP SLIDESDetails about ChemStore migration

BACKUP SLIDES


1. Submit basic information to Agilent

3. Migration process1. Submit basic information to Agilent

• Software revision of ChemStore

• Software revision of Agilent ECMg

• ChemStore Data Base History

• your envisioned migration schedule

• Cut-off date (in case of a partial extraction)Cut off date (in case of a partial extraction)

• 2. Diagnose Phase performed with the help of the ChemStore Admin Tool

• ChemStore database export sizep

• how many and which archives to retrieve, size of those archives

• Number of runs

• Report on this should be send to PSOReport on this should be send to PSO


3. The ProcessORACLE

3. PSO sends offer

• Database report used as a bases for the offer

Database Export

+ Archiveunits

Database report used as a bases for the offer

• Provide Schedule / Migration plan

• Offer includes appropriate exchange media (typically USB drive)

• The Offer mentions all archives which need to be retrieved• The Offer mentions all archives, which need to be retrieved

4. Migration preparation

• You will receive appropriate exchange media (typically USB drive)

• Database must be ‚retired‘. No further acquisition or reprocessing on retired production database

• Oracle Administrator creates ChemStore DB ORACLE Export and restores all archive files to the exchange media


Compliance

3. The Migration ProcessCompliance ServiceArchive

unitsChemStation

Sequence

ChemStoreTrace data-

base

Agilent

zip SSI ZIP containers

upload,

filtering

extractretired

Ch St

containers

ChemStation Single Run container Agilent

OpenLABECM

ChemStoreDatabase(updated to rev.

B.04.01)

ACAML

Catalog file

ChemStationB.04.01


Analytical Data Viewer

4. After Migration: View Results

• Set up a search in Agilent ECMThe overview lets you sort your data by fields

• View data with Analytical Data Viewer

data by fields

If you double-click on a row youIf you double click on a row you open your data in the details

view


4. After Migration: View Results

Details show your results and all related filesall related files

If you click on a signal, the viewer

will openView audit trails, approvals andwill open approvals and

files


Data Reprocessing with ChemStation

ChemStation B.02.01: Single run processing and auto-stepping of sequence runsChemStation B.04.01 SP1: Sequence reprocessing of ChemStore legacy


data

ChemStore / Agilent ECM MigrationProduct CompatibilityProduct Compatibility

Software Application Revision number

comments

ChemStation A.06 or higher

ChemStore(O l b d l )

B.01.01 –B 04 0

Microsoft Access® databases will be i t d t O l ® DB fi t(Oracle based only) B.04.0x migrated to an Oracle® DB first

ECM 3.02.xx

Reprocessing Software ApplicationChemStation B.02.01 SR1 Reprocess sequences and single runs

or higherEZChrom or OpenLAB ICM Single run chromatogram

trace (.CH file) can be reviewed


5. Support and Compliance: Mi i V ifi i P lMigration Verification Protocol

• The migration process is formalized and documented.

Agilent creates a “Migration Verification Protocol” which allows detailed recording of the migration process.

• Delivery

The Migration Verification Protocol is paper based. Any deviations of the described workflow are documented by the Agilent service engineer It also contains any log filesAgilent service engineer. It also contains any log files created by tools used.


ChemStore future 2 - Chemical Analysis, Life Sciences, … future of ChemStore isChemStore is…...

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