// Site manager (SSM)

Level 3 qualification documentation and validation plan

// Vimachem offers a complete validation plan

Conforming with the GAMP5 risk-based methodology

Our team of experts will partner with your organization to provide complete validation plan.

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Our plan consists of

Event Schedule Streamline Icon: https://streamlinehq.com event-schedule
Initial System Risk Assessment (ISRA)
Status Resolved Streamline Icon: https://streamlinehq.com
User Requirements Specification (URS)
Location Save Streamline Icon: https://streamlinehq.com
Validation Plan (VP)
Document Multiple 02 Streamline Icon: https://streamlinehq.com
Test Cases
Ibm Cloud Security Compliance Center Workload Protection Streamline Icon: https://streamlinehq.com
Installation Qualification (IQ)
Cloud Monitoring Streamline Icon: https://streamlinehq.com
Operation Qualification (OQ)
User Service Desk Streamline Icon: https://streamlinehq.com
Functional Risk Assessment
Cloud Auditing Streamline Icon: https://streamlinehq.com
Test Report (executed Test Cases)
Drill Through Streamline Icon: https://streamlinehq.com
Traceability Matrix (TM)
Checkbox Checked Streamline Icon: https://streamlinehq.com checkbox--checked
Validation Report (VR)
Receipt Streamline Icon: https://streamlinehq.com receipt
SOP and technical documents for the use of the Vimachem Level 3 Serialization Site Management (SSM) system
Notebook Reference Streamline Icon: https://streamlinehq.com notebook--reference
User manual

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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