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Auto-Validation Software

890-0050 Auto-Validation software – One license needed per computer(can be used for all LaChrom Elite instruments attached to one PC)

Accessories

4.02011.0001 Teflon tube 0.25 mm ID x 10 m

Recommended accessories

609-1118 Stop watch DELTA E200620-4703 Thermometer QTemp 500620-4705 Temperature sensor ALS300 (two units are needed)

Consumables

1.19161.0001 Set 7: Precision (OQ)60 mg/l methyl paraben in methanol

1.19162.0001 Set 8: Linearity (OQ)Dilution series of methyl paraben in methanol(concentrations: 1.5 ; 7.5 ; 15 ; 75 ; 150 mg/l)

1.19163.0001 Caffeine solution A for gradient test (OQ)20 mg/l caffeine in water

1.19164.0001 Caffeine solution B for gradient test (OQ)20 mg/l caffeine in methanol

1.15333.1000 Water, Lichrosolv1.06007.1000 Methanol, Lichrosolv1.50164.0001 LiChroCART 125-4 HPLC Cartridge

Autovalidation – A new tool to qualify your Hitachi LaChrom Elite® HPLC.

AustriaVWR International GmbHGraumanngasse 7A - 1150 WienTel: +43 1 97 002-0Fax: +43 1 97 002 600E-mail: [email protected]

BelgiumVWR International bvbaHaasrode Researchpark Zone 3Geldenaaksebaan 464B - 3001 LeuvenTel: +32 16 385011Fax: +32 16 385385E-mail: [email protected]

DenmarkVWR International ApSRoskildevej 16DK - 2620 AlbertslundTel: +45 43 86 87 88Fax: +45 43 86 87 90E-mail: [email protected]

FinlandVWR International OyPihatörmä 1 C 1FI - 02240 EspooTel: +358 9 804551Fax: +358 9 80455200E-mail: [email protected]

FranceVWR International S.A.S.Le Périgares – Bâtiment B201, rue CarnotF-94126 Fontenay-sous-BoiscedexTel: 0 825 02 30 30 (0,15 € TTC/min)

Fax: 0 825 02 30 35 (0,15 € TTC/min)

E-mail: [email protected]

GermanyVWR International GmbHHilpertstrasse 20aD - 64295 DarmstadtTel: +49 6151 3972 500Fax: +49 6151 3972 441E-mail:[email protected]

IrelandVWR International LtdRath Business ParkAshbourneCo. MeathTel: +353 1 835 0005Fax: +353 1 835 0029E-mail: [email protected]

ItalyVWR International s.r.l.Via Stephenson 94I - 20157 Milano (MI)Tel: +39 02 3320311Fax: +800 152 999E-mail: [email protected]

NorwayVWR International ASKakkelovnskroken 1P.B. 45, Kalbakken NO - 0901 OsloTel: +47 02290Fax: +47 22 90 00 40E-mail: [email protected]

PortugalVWR International – Materialde Laboratorio, Lda. PortugalRua Alfredo da Silva 3-CP - 1300-040 LisboaTel: +351 21 3613605/608/609Fax: +351 21 3613666/7E-mail: [email protected]

SpainVWR International Eurolab S.L.Apartado 48E-08100 Mollet del Vallés -BarcelonaTel: +34 902 19 56 44Fax: +34 902 19 59 39E-mail: [email protected]

SwedenVWR International ABFagerstagatan 18aSE - 163 94 StockholmTel: +46 8 621 34 00Fax: +46 8 621 34 66E-mail: [email protected]

SwitzerlandVWR International AGLerzenstraße 16/18CH-8953 DietikonTel.+41 44 745 13 13Gratisfax: 0800 825 429E-mail: [email protected]

The NetherlandsVWR International B.V.Postbus 8198NL - 1005 AD AmsterdamTel: +31 (0)20 – 4808 400Fax: +31 (0)20 – 4808 480E-mail: [email protected]

UKVWR International LtdCustomer Service CentreHunter Boulevard - Magna ParkLeicestershire - LE17 4XNTel: 0800 223344Fax: +44 1455 558586E-mail: [email protected]

Your European Distribution Partner

LaChrom®, LaChrom Elite®

and ChromSword® areregistered trademarks of VWRInternational,

EZChrom Elite™ is aregistered trademark ofScientific Software Inc.

The Auto-validation software� Performs the instrument OQ and produces data which com-

plies with the electronic records and electronic signaturerule (21 CFR Part 11).

� Keeps all the qualifications performed on an instrument(history).

� Follows all hardware manufacturers standard operatingprocedures (SOP’s)

� Runs as automatic as possible, freeing the technician andanalyst from time-consuming manual procedures.

� Enables system testing as well as single parameters.� Is fully integrated into the EZChrom Elite platform

How often should the instrument OQbe performed?The frequency of OQ depends on the use of the LaChrom Eliteinstrument, but also on the specified acceptance criteria.The use of the instrument is highly depended on how oftenanalysis are performed (continuous operation?) and howfrequently aggressive solvents and samples are analysed.The default acceptance criteria is given by the instrumentSOP’s.This will be entered as default values as soon as you start aqualification run.

What tests will be performed?

The instrument OQ typically comprises the following testitems:

Pump Tests� Flow rate Accuracy� Flow rate Precision� Gradient Accuracy� Gradient Ripple

Autosampler Tests� Injection Amount Repeatability� Carry Over� Injection Amount Linearity

Oven Tests� Temperature Accuracy � Temperature Stability

Detector Tests� Lamp Energy� Wavelength Accuracy� Auto Zero Function� Baseline Noise/Drift� Absorbance Linearity

What

can EZChrom

Elite do for you?

� Performs and documents automatic

operational qualification

� Provides qualification data that complies

with FDA’s 21 CFR Part 11

� Increase the productivity by performing a

step-by-step qualification with a minimum

interaction by the analyst

� Keeps the qualification data online

as long as needed to master the

next inspection.

ZPRO

VWRI

2003

EN

A new tool to qualify yourHitachi LaChrom Elite® HPLC

Auto-Validation

as ms em 07/2005

Autovalidation.qxd 11/07/05 17:09

Installing and checking an HPLC instrument in a regulatedenvironment is a time-consuming and complicated procedure.New instruments as well as used equipment, which isupgraded after a service or repair requires re-qualification. Thecustomer must also decide how often a qualification must berepeated, depending on the use of the instrument as well asthe acceptance criteria being used.

The Auto-Validation package fromVWR International addresses these requirements for the Hitachi LaChrom Eliteinstruments and comes as an out-of-the-box package tocompletely perform a qualification� Includes the software� Comes with a comprehensive manual� Standard solutions are available on request� Solvents are available on request� A column and a capillary hardware is available on request� The Auto-Validation software is fully implemented into the

EZChrom Elite platform and takes the user from the set-up tothe printout of the qualification report.

HPLC instruments, which are used in regulated laboratories,must be validated to fulfill certain requirements:� GLP (Good Laboratory Practice)� FDA’s 21 CFR Part 11 (Rule of electronic records and

electronic signatures)� Other regulations (Local regulations, company policies, etc.).

A validation procedure consists of thefollowing steps:

User SpecificationsUser requirements Functional spec Testing plans, etc.

Installation Qualification (IQ)To ensure proper installation of the softwareChecksum testingInstallation specific entries, etc.

Operational Qualification (OQ)To ensure proper performance of the HPLC hardware andsoftwareSoftware OQ – to show the software calculates correctlyInstrument OQ – to show the proper performance of the HPLChardware

Performance Qualification (PQ)The on-going testing by the customer

Of all the different steps the operational qualification (OQ)and the performance qualification (PQ) have to beperiodically performed.

Operational qualification (OQ) is the process ofdemonstrating that an instrument will function accordingto its operational specification. The instrument OQ is thetime consuming part of the validation procedure.

The Auto-Validation software runs an automaticinstrument OQ and therefore addresses this requirementfor the Hitachi LaChrom Elite instrumentation.

After finishing the qualificationthe auto-validation software

� prints a quick report

� includes all graphs (spectra,chromatograms, etc.)

� can print a summary of theauto-validation results

� uses the full EZChrom Elitereporting capabilities to insertthe validation results into amethod report

� Confirm the settings for the testsequence

� A wizard will guide the user through thehardware preparation

� Run the qualification

� Re-run failed test items if necessary.

Performing the Qualification Tests2.

Printing the OQ Report3.

� Specify the acceptance criteria for thedifferent modules in the instrument(the defaults are the values from theSOP)

� Describe the measuring instruments(thermometer, stopwatch, balance,samples, solvents, column) with theirserial no. and expiration date of thecalibration

� Confirm the test sequence.

Setting up the Test Sequence1.Setting up the test sequence (example screens)

Running the Auto-ValidationThe Auto-Validation is performed in three steps:

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