PowerPoint Presentation33
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Lighthouse LMS Pharma
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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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From URS to Handover | EMS Overview
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From URS to Handover | EMS Overview
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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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manufacturers, LAF Technologies has
respected suppliers of contamination
control, environmental monitoring and
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
advanced products and services at very
competitive prices.
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
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
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.
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1515 http://www.laftech.com.au
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From URS to Handover | EMS Then vs. EMS Now
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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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From URS to Handover | Initiation & Kick-Off
• What are we monitoring? • Where are we monitoring? • When does it get installed?
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From URS to Handover | Initiation & Kick-Off
• 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!
• 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!
• 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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From URS to Handover | Initiation & Kick-Off
….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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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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From URS to Handover | On-going Management
• 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…
The wider the knowledge gap, the bigger the phone bill.
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From URS to Handover | On-going Management
• 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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It doesn’t matter how good you are…
Sometimes, you get it wrong.
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Fix it properly…
Fix it properly…
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• Allow the time for detailed document reviews
• Allow time for problems during validation – that’s the whole point of it!
• Avoid “good enough” patch up jobs
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• Good training is critical in a successful handover.
• Know who’s responsible for what. Get the RIGHT training.
• Modular Training
• Training Resources
4242 http://www.laftech.com.au/emshelp
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• Review the IQ/OQ
• Review the scope
SIGN OFF!
…separation anxiety
…until next time!