THE LATEST IN SUPPORT

TECHNOLOGY

Improving Equipment Availability and Effectiveness of Your Laboratory Instruments Agilent Science and Technology Symposium 2012

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Do more with the same (or less)

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Δ17%

Survey respondents were asked about laboratory trends they see over the next year

Laboratory Service & Support – Strategic Directions International, Inc., August 2011

The challenge now is to optimize workflows and equipment effectiveness

Agenda

Agilent Remote Advisor Technology – Remote Advisor Assist Demo – Remote Advisor Alert Demo – Case Studies Using Remote Advisor Reports

Agilent Compliance Engine Technology – Regulatory Landscape – Agilent Enterprise Edition – Benefits from Agilent Compliance Engine – Enterprise Edition Case Study

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Agilent Remote Advisor The latest support technology

Agilent Remote Advisor is a secure, remote diagnostics and asset reporting technology

Provides faster problem resolution and detailed reports. – Remote Advisor Assist: Simple Access

– Remote Advisor Alert: Proactive Notification

– Remote Advisor Report: Detailed Insight

Dispatch Phone call Entitlement questions

Basic problem understanding

Level 2 technical

questions

Experience based cause

prediction 6

Push For Help

Real-Time data collected:

• ID & entitlement • Historical system data • PC information • Remote diagnostics

THEN we call you for additional diagnostics or remote fix

Agilent Call Centers conduct advanced diagnostics

Dispatch

Engineer is sent with more

complete information and the right parts

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When a failure occurs, how many steps involve you?

Remote Advisor Assist Saving you steps

Remote Advisor Assist What you’ll see in the lab

You simply verify the contact details, add any comments and click the ‘Submit’ button.

Your request + instrument diagnostics are automatically gathered and sent to Agilent

Remote Advisor Assist What the Agilent Support Center sees

Agilent sees a diagnostic view of your instrument including:

– Configuration – Serial numbers – Instrument log files

We do not see your methods, results or desktop.

Remote Advisor Alert

What if you could PROACTIVELY prevent instrument problems before they occur?

Remote Advisor Alert Notifies you by text or email when an instrument needs your attention

- When instrument system errors occur

- When maintenance thresholds are reached

Remote Advisor Alert What you’ll see in the lab

Every time the event occurs, Remote Advisor will send you a text or email within 15 minutes

Especially useful for extended runs or after-hours runs

Remote Advisor Report Reports available on-demand

Report Templates include: Lab at a Glance - inventory

Asset Report – individual availability and utilization

Availability & Utilization – capacity of your total inventory

Required Maintenance – usage

Scheduled Services – periodic maintenance status

Module Movement – module tracking

Error History – list of errors

Repair History – list of Agilent repair/maintenance visits

Column Injections – workload distribution

Plus custom reports

Remote Advisor Case Study: Streamline asset management

Global Top 5 Biotech company spending hours of analyst time on audit preparation activities. Challenge:

– Analysts time lost to non-productive work

– Consolidating paper-and-ink instrument logs and service records is a pain point

– Data accuracy is only as accurate as compliance to log-book usage

QC department approved the connection of 48 LC systems across 6 laboratories.

Remote Advisor Case Study: Streamline asset management

Remote Advisor Reports streamlined audit preparation – with inventory time reduced to only 1% of the time that it took before.

Remote Advisor proved to be a great application to help us prepare for the audit. Information directly from the instruments was available instantaneously which gave us a definite boost in terms of data quality, reliability and compliance. Senior Laboratory Manager Global Top 5 Biotech Company

Remote Advisor Reports used: Lab at a Glance (Inventory) Repair History

Remote Advisor Case Study: Improve utilization and reduce waste

In the “walk-up laboratory” where instruments are available for on-demand use, analysts frequently reported that they could not secure time for their analysis – especially in the afternoon. The lab manager was challenged to :

– Accurately track and measure system usage

– Identify ways to improve system utilization and more efficiently manage their inventory

Remote Advisor collected system utilization data from 8 HPLC/LCMS systems for one month.

Remote Advisor Case Study: Improve utilization and reduce waste

Remote Advisor shows that the systems are available 87% of the workweek – but are sitting in the ‘Ready-to-Run’ state.

– Systems are running analysis on average only 10 minutes a day between 1:00 and 2:00 p.m.

– Many systems see little more than 1 hour of use per day

Manager asked users to be more vigilant about releasing systems after their analyses are complete in order to open up capacity

Remote Advisor Reports used: Availability & Utilization Report

Remote Advisor Case Study: Improve utilization and reduce waste

Excessive Ready-to-Run time adds unnecessary cost

– Waste of consumables (e.g., lamps) and solvents (which must be disposed of)

– Decreases time between failures by causing wear on the system

Lab removed ~145 hours of Ready-to-Run time across the lab, resulting in:

– Reduced 14,000 hours of lamp time a year saving $6300

– Removed 14,000 hours of solvent waste

– Increased MTBF by 35% or 72 days

Remote Advisor Reports used: Availability & Utilization Report

Agilent Compliance Services Innovations in Compliance

Regulatory Landscape 483s and Warning Letters

The FDA issued a 483 every 50 minutes in 2011. This will be the 3rd consecutive record-breaking year, and the 2nd time in FDA history to have issued more than 10,000 483’s in 1 year.

www.fda.gov/downloads/ICECI/EnforcementActions

FDA Enforcement Statistics Summary Fiscal Year 2011

www.fda.gov/downloads/ICECI/EnforcementActions

FDA Warning Letters 2004-2011

Innovation in Compliance Agilent Enterprise Edition

Agilent Enterprise Edition analytical instrument qualification is automated, paperless and compatible with instruments from all leading vendors.

Enterprise Edition reduces regulatory risk: – Harmonization across instruments

– Flexibility to configure testing to SOP requirements

– Full automation to assure adherence to protocol

– Electronic reports and signatures

Agilent Enterprise Edition Innovation Equipment Qualification Plan - Universal Protocol

Harmonization

– Single protocol per technique

– Protocols compatible with systems from all leading vendors – Waters, PerkinElmer, Thermo, Shimadzu

– One protocol for QA to approve saves time

Testing Flexibility

– Specify testing based on your SOP requirements

– Specify setpoints/limits, add/remove tests – all without interfering with test design

Agilent Enterprise Edition Innovation Configurable testing

Agilent Enterprise Edition Innovation Paperless Reports Single locked .pdf report

More secure GxP record One single signature required

All-electronic information Legible data entries, results and signatures Electronic Routing for review Export to external ECM and data bases

Reports burned to CD-ROM Total integrity, 21 CFR Part 11, ISO compliant format Less storage space and lower archival costs

Agilent Enterprise Edition Innovation Agilent Compliance Engine

Agilent Compliance Engine (ACE) efficiently enforces compliance to procedure

– Fully automated protocol

– Validated calculations

– Simultaneous qualification

– Results fully traceable to raw data

– Reports free of transcription errors

– Automated pass/fail report

Agilent Enterprise Edition Case Study

Company manufacturing APIs. The QC Lab management team set out to significantly increase productivity and reduce costs as part of a Six Sigma commitment to continuous improvement. With more than 500 instruments from multiple manufacturers, the QC Lab was challenged to:

• Free chemists from routine maintenance

• Reduce instrument downtime

• Streamline the regulatory compliance process

Agilent Enterprise Edition Case Study

“A compliance qualification report review task that once took as long as three hours can now be accomplished in just 30 minutes – and with greater accuracy. It’s the solution our chemists have been looking for.” Principal Scientist

Company achieved real results:

• ~200 hours of PhD chemist time rescued from compliance-related work

• 80% reduction in QA review / approval time

• 55% less compliance-related downtime

• Compliance data now track trends, compare performance, and drive operational decisions

Summary

Technology innovation from Agilent is not restricted to your instruments.

– Agilent Remote Advisor and Agilent Enterprise Edition represent our commitment to helping you control costs and optimize your operations

– We can help you optimize workflows and equipment effectiveness across the lab

Learn more..

• www.agilent.com/chem/remoteadvisor

• www.agilent.com/chem/comply1

Thank You