// Site manager (SSM)

Level 3 installation, validation execution and project management

// Track and trace

End-to-end serialization support

Our team of expert consultants will partner with your organization to provide complete end-to-end serialization (Track and Trace) support that you need to achieve cost-effective compliance.

We bring world class expertise and support developed from 10+ years of support dedicated to the Life Sciences industry

Our expert technical consultants and project managers will support your organization with the implementation and qualification of the Vimachem SSM Level 3 system as well as with the implementation of the Tracelink Life Sciences Cloud (Levels 4 and 5), offering an integrated solution for serialization Levels 3 to 5 that allows reduced implementation time and pragmatic end-to-end validation.

During installation and validation execution Vimachem will

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Install the Vimachem Level 3 Serialization Site Management (SSM) system to two servers, production and test, and perform the installation qualification (IQ)
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Integrate the Vimachem Level 3 site management system to the Tracelink Life Sciences cloud and the line level equipment and perform the installation qualification (IQ)
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Support, if requested, with production qualification (PQ)

Vimachem throughout the project lifecycle will provide project management services for

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Project coordination and communication with global stakeholders
Document Requirements Streamline Icon: https://streamlinehq.com
Technical requirements and specifications definition
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URS analysis
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Scheduling of time and resources, monitoring and change management, continuous monitoring of project milestones

After the successful qualification of the level 3 site management system, Vimachem will train the resources in the successful operation of the Level 3 site management.

What it is like working with Vimachem

See all case studies

Sharp Sterile Establishes a Foundation for Multi-Site Manufacturing Analytics with Vimachem's OEE Platform

Sharp Sterile Manufacturing

Pharmaceutical Manufacturing

2 months

Implementation time

2 lines

Sterile fill-finish

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How Purna Pharmaceuticals N.V. Implemented Vimachem SSM Level 3 and Level 4 to Support Multi-Client Liquid and Cream Packaging

Purna Pharmaceuticals N.V. (Contract Manufacturer)

Pharmaceutical Manufacturing (CDMO)

Level 3 + 4

Serialization and reporting

5 lines

Serialization-equipped, of 15 total

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From Paper-Based to Scalable Serialization! How Fulton CDMO Standardized on Vimachem Level 3 SSM & Manual Aggregation Module to Enable Compliance and Growth

Fulton Medicinali (CDMO)

Pharmaceutical Manufacturing (CDMO)

12 weeks

To go-live

7 tickets

Support tickets in two years

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Labatec Achieves a 30% OEE Increase (86% Relative Improvement) and 324% ROI with Vimachem's Manufacturing Analytics and OEE Solution

Labatec

Pharmaceutical Manufacturing

+30 pts

OEE increase

324%

ROI

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From 41% to 65% OEE! A 59% Increase - Inside Astrea Pharma's OEE Breakthrough on their First Production Line with Vimachem's MA & OEE.

Astrea Pharma

Pharmaceutical manufacturing

41 to 65%

OEE on the first line

59%

Relative increase

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How ELPEN Increased OEE by 90% and achieved 299% ROI with Vimachem's Manufacturing Analytics & OEE solution

ELPEN

Pharmaceutical manufacturing

90%

OEE increase

299%

ROI

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Ensure On-Time Drug Shipments: How to Quickly Replace Your Serialization System with the Leading Track-and-Trace Platform

HELP Pharmaceuticals

3 months

Full L3 to L5 replacement

Zero

Production downtime during cutover

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Serialization Compliance in Russia with Medice and Wipotec

MEDICE Arzneimittel Pütter GmbH & Co. KG

3 weeks

Average time to upgrade for market compliance

Zero

Line stoppages to test the integration

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Serialization Driving Innovation & Change With RFID

Fresenius Kabi

15 to 30 min

Manual tray check before RFID

250 vials

Read in a single pass after RFID

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Serialization For Global Medicines Traceability

Aspen Pharmacare Australia

10

Export markets supported

5

Packaging lines serialized

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Pharma Trackts 2021 | Serialization Driving Change And Innovation

IBERFAR, Indústria Farmacêutica S.A.

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