From URS to Handover - PharmOut€¦ · From URS to Handover | EMS Overview. 13 Corporate Overview...

EMS Project Management

From URS to Handover

Presented by Matt Kennett

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From URS to Handover | Introduction

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Lighthouse LMS Pharma

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From URS to Handover | EMS Overview

What is an EMS?

Room / Area• Temperature• Relative Humidity• Pressure• Particle Counts• Gas Levels

Plant / Equipment• Particle Counts• Temperature• Pressure• CO2%• Fault Status

The EMS monitors and records environmental parameters in

controlled environments. It is independent from the controlling

system. It is GMP validated, and is relied on heavily for providing

data and reports for regulatory compliance.

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REAL-TIME ALARMS


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SMS and Email Notifications


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Real-Time Audible / Visual Alarm Indication


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Particle Monitoring (Grade A BSC)


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CO2 Incubator• Temperature• CO2%• Equipment Fault

Liquid Nitrogen Tank• Temperature• High Level Alarm• Low Level Alarm• Equipment Fault

Lab Fridge• Temperature• Equipment Fault

Equipment Monitoring


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Corporate Overview

Established in 1987 and representing some

of the world’s leading equipment

manufacturers, LAF Technologies has

rapidly grown to become one of

Australasia’s largest, most successful and

respected suppliers of contamination

control, environmental monitoring and

advanced measurement instrumentation.

Fully NATA accredited to ISO17025, the

company is also arguably Australasia’s

leading service provider in the specialized

testing, decontamination and validation of

clean rooms, biological safety cabinets,

laminar air flow cabinets, fume hoods and

controlled environments. With offices in

Melbourne and Brisbane and specialist

distributors and service providers positioned

throughout Australasia, LAF Technologies

is committed to providing technically

advanced products and services at very

competitive prices.

The company is 100% Australian owned

and employs a wide variety of specialist

sales staff, service technicians, engineering,

field and support staff, along with other key

personnel. LAF Technologies also prides

itself on maintaining state-of-the-art service

/ repair facilities, NATA & ISO21501-4

accredited calibration laboratories and a

popular rental department, all in an effort to

provide flexibility and total peace of mind for

our valued clients. The company is also fully

ISO9001 quality accredited and maintains

accreditation to the latest ECO WARRANTY

environmental management standards. Our

national field services team employs a large

network of highly trained industry

professionals who operate 24/7 providing

world class testing services to the latest ISO

international standards for many of

Australasia’s leading manufacturers and

research organizations.

From URS to Handover | Corporate Overview

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1515http://www.laftech.com.au


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From URS to Handover | EMS Then vs. EMS Now

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• Increasing demand

• Better technology and platforms

• Practical knowledge and planning is often lacking.


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From URS to Handover | Initiation & Kick-Off

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EMS Project Management: From URS to Handover

No time for a plan…

• Options not looked at

• Immediate design constraints

• Working to a budgetary figure rather than a list of requirements

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• What are we monitoring?• Where are we monitoring?• When does it get installed?

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• What are we monitoring?• Where are we monitoring?• When does it get installed?

• How can we suit the EMS to what we do?

• Who is responsible for management of the system?

• Why reinvent the wheel? Seek advice!

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Invest in an expert. It will save you later.

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Develop that URS!

• The backbone of a well executed EMS project

• Documented traceability from day one

• Ensures every single design requirement is met, accounted for, and delivered AS EXPECTED

• No matter how simple or complex the requirement. Get creative. Today’s systems are very capable.

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Develop that Scope!

• Straight forward, accurate definition of project deliverables

• A clearer picture at handover

• Important for us to be able to say we’re 100% complete

• Equally as important for the customer to be able to identify project shortfalls

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….when choosing the System and Supplier that’s right for you

• Suitable Technology – Modern and current is crucial

• Support and Service – Local? International? On-the-spot support?

• Quality of URS response – Do they really meet your needs?

• On-going management requirements – Cheap now / Expensive later?

• Reference Sites – Get the low down before you engage

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From URS to Handover | On-going Management

Well, who’s responsible for all this then?

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NATA Accredited Particle Counter Calibration Facility @ Laftech, Melbourne

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You want me to what?!

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• Heavy reliance on in-house networks and IT systems• Usually installed alongside facility IT systems• IT departments in smaller companies are struggling!

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THE IT CONSULTANT…

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The wider the knowledge gap, the bigger the phone bill.

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• Get it sorted out early in the project!• Customer confidence at system handover• Maintenance costs are known from day one• All works pre-scheduled and prioritised

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From URS to Handover | Installation Issues

It doesn’t matter how good you are…

Sometimes, you get it wrong.

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Fix it properly…

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Fix it properly…

Don’t just get it over the line

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From URS to Handover | Validation Issues

• Allow the time for detaileddocument reviews

• Allow time for problemsduring validation – that’s thewhole point of it!

• Avoid “good enough” patchup jobs

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From URS to Handover | User Training & Support

• Good training is critical in a successful handover.

• Know who’s responsible for what. Get the RIGHT training.

• Modular Training

• Training new users in the future

• Training Resources

4242http://www.laftech.com.au/emshelp

From URS to Handover | User Training & Support

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From URS to Handover | System Handover

• Review the IQ/OQ

• Close out any outstanding actions

• Review the scope

• Close out any outstanding actions

SIGN OFF!

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From URS to Handover | System Handover

…separation anxiety

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From URS to Handover | Thanks for having us!

…until next time!

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From URS to Handover | Questions?

From URS to Handover - PharmOut€¦ · From URS to Handover | EMS Overview. 13 Corporate Overview...

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