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Biomerieux

Created on March 18, 2025

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Transcript

Qualification and Validation Execution by 3rd party

FAQ

DISCOVER/LAUNCH

OFFER CONTENT

PROCESS

SCOPE of AMARIS execution

Project SCOPE

PROCESS

Covered Countries

Service Capacity Planning

Ranges

Sales Process Overview

Documentation

Support / Complaint Handling Process

Support documentation

Offer content

Click on each item to discover

Discover AMARIS

Who to contact

Swiss Company created in 2007

7600 people

International Presence60+ COUNTRIES

1000 clients across the world

Countries are covered by Wave 1?

Mexico Manager cksalou@amaris.com

Kenny SALOU

Chloé THEVELIN

Asia Plate Managercthevelin@amaris.com

Geoffrey EDEL

Brazil Managergedel@amaris.com +55 (11) 95022-1981

Antoine TULASNE

Brazil Senior Manageratulasne@amaris.com

Service Capacity Planning

Wave 1

COUNTRIES

Be part of the wave 1 Launch the Local G2M

Project
~2-3 weeks

Start-up Time

Enroll Sales and Marketing team / hotline... Be aware of this new offer Read about the "3rd Party execution" Service Package

Training

Set up supplier locally - Everything is already contractualized at the global level - no need to create a local contract

SUPPLIER
Configuration

Open locally dedicated SAP references. If applicable, activate automatic process to order

SAP ref.

Identify for the first deployment local people to support - if necessary, the subcontractor

Fivefirst steps

Who

AMARIS key contacts

Chloé THEVELIN

Asia Plate Managercthevelin@amaris.com

Olivier REINS

Delivery Manager, International

olivier.reins@amaris.com

Who

Kenny SALOU

Local contacts

Mexico Manager cksalou@amaris.com

Eric VOYRON

Geoffrey EDEL

Life Science France Managereric.voyron@amaris.com

Brazil Managergedel@amaris.com +55 (11) 95022-1981

Antoine TULASNE

Brazil Senior Manageratulasne@amaris.com

Process for Launch

Discover AMARIS

Service Capacity Planning

Covered Countries

Sales Process Overview

Documentation

Support / Complaint Handling Process

Support documentation

Offer content

Click on each item to discover

SCOPE: Ranges

with/without Myla/CODEX

VITEK 2 COMPACT

BACT/ALERT 3D

BACT/ALERT VIRTUO

VITEK 2 COMPACT PRO

ENDONEXT

VITEK MS LEGACY

VITEL MS PRIME

ACCELLIX

SCANRDI

BIOFIRE FILMARRAY

Ranges which are already available

ranges for which amaris is not already trained

Outsourced Qualification / Validation standard offer ?

Reagents

IN

Method Suitability TEsting: for 1 customer Product

QUALIFication: For 1 equipment

For BTA ranges;Thermal Mapping

Strategy / Kick off Definition with customer

Potential Customization

Protocols and Documentation

OUT

Execution on siteManagement of deviations

Travel expenses

Sales Process

Commercial relationship remains between bioMérieux & customer. The end-to-end process is managed locally by bioMérieux sub, with the support of global if necessary.

PROMOTE

COST

BUY

EXECUTE

PAY

PRICING GUIDELINES

SCOPE

QUOTE

ORDER

COMPLETE

INVOICE

COMPLAINTS HANDLING PROCESS

Support Documentation

Statement of work

??

Scoping

Supplier Creation

END

START

Creation of Work Order

Certificate of Completion

Marketing Brochure

Pricing Book

FAQ

A F.A.Q online is available on

GCS PORTAL

Business & Pricing Guidelines

If the customer wants customisation,Subcontrator (AMARIS) quotes bioMérieux sub for the project.

Standard price if no customisationRefer to Pricing Book

Standard offer

Custom offer

Lucila Sabeckis Global application specialist for GENE-UP®. Dedicated to XPRO™ assays, non-beverage markets (e.g., nutraceuticals, animal protein, cannabis). lucila.sabeckis@biomerieux.com

Customer purchases a validation service package from biomérieux
bioMérieux purchases a Qualification / Validation service execution from AMARIS

Customer

biomérieux

AMARIS

QUOTE

bioMérieux sub quotes customer for the project

WHAT
HOW

The GCS Portal administrator needs to add your new product in the existing list of products so that communications concerning this product are well categorized.

Contact the GCS Portal Administrator to update the list of products available in the portal.

PAY

Partner invoices bioMérieux sub

bioMérieux sub sends Purchase Order (PO) to partner (EPROC)

Eproc will be used to launch the project. An automatic process in SAP is being set up: the purchase order will automatically send an email to the supplier - in this case AMARIS. It's a solution that avoids manual eproc processing and links purchase and sale without constraint.

BUY

Customer signs the quote.

INVOICE

bioMérieux sub (local) INVOICES Customer

The template document is available here

COMPLETE

Before leaving customer site, a certificate of completion is signed by customer. The WO must be closed as when a bioMérieux FAS execute Qualification/Validation.

PROMOTE

Account manager promotes the offer during solution selling

Turnkey solution to the customer

Documentation

Our partners can provide the service in a matter of weeks= No delay in getting the system up and running

Differentiating factor from the competition

Subcontractor plans & executes the project

Remote steps:

ON-SITE:

PREREQUISITES

1. PROPOSAL

2. GUIDANCE

1. Knowledge transfer and qualification strategy 2. Take protocols ownership

  • Preparation & submission of protocol to customer for review
  • Incorporation of comments or additional tests
  • Knowledge transfer and qualification strategy
  • Take protocols ownership

TESTS EXECUTION

EXECUTION

Brief description

  • Management of activities
  • Execution of IQ/OQ/PQ tests and/or MV/MST
  • Documentation and resolution of deviations arising during protocol executions

Create a WO for AMARIS

SCOPE

CUSTOMER

Local (global) FAS organizes call for scoping and scheduling with customer and Subcontrator (AMARIS):3 parties kickoff meeting.