On your way to the paperless lab

Easy. Secure. TÜV approved.

Radiopharmacy Laboratory Information & Management System (R-LIMS)

Puts you on the way to the paperless radiopharmacy lab.

• Tailored to radiopharmaceutical labs with the know-how of pharmaceutical industry built in.

• Contains SOPs for standard products and many adaptable templates (option).

• Maps all your laboratory processes, from incoming chemicals and goods to releasing probes and own products.

• Adapts to your needs by its modular structure and expandability.

• Operates intuitively and is user friendly.

• Reduces risks by full compliance with all relevant standards & regulations.

All this, with the guarantee of meeting the strict provisions of GLP/GMP, ISO 9001 and ISO 17025. This combination results in a high level of acceptance from employees, customers and vendors and contributes to efficient work in laboratories.

The solution for you: Flexible. User-friendly.

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Scintomics universe of Radiopharmacy Lab Automation: Workflow. Easy.

GRP™ Radiopharma-ceutical Production

HPLCGRP

Module GCGammaSpectro-

meterTLC Activity-

meter

Quality Control

RadioactivityMeasurement

Production Data & Management

QC Data Acquisition & Management

Daily radiopharmacy Laboratory processes

Daily radiopharmacy Laboratory processes

Radiopharmaceutical Laboratory Information & Management ((R)LIMS)

SCC

WIP* WIP*

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Raises your confidence: Secure. Compliant.

Access protection and strict rights assignment secure your system and your data.At the same time – it can provide the basis for your seamless communication: internally, but also with customers and suppliers.

• User and access rights assignment at different levels• Access protection • GMP-compliant logging of access data • Communication platform with customers & suppliers All this, with the guarantee of meeting the strict provisions of GLP/GMP, ISO 9001 and ISO 17025. This combination results in a high level of acceptance from employees, customers and vendors and contributes to efficient work in laboratories.

Compliance: GLP/GMP, FDA, ISO 9001/17025, GAMP5 SW Cat. 4, TÜV approved

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Diagnostics Therapy

18F-TRACER 68Ga-PEPTIDES 177Lu-PEPTIDES

o 18F-Fluoride

o 18F-FLT

o 18F-FMISO

o 18F-FMC

o 18F-FDG

o 18F-6-FDG

o 18F-Choline

o 68Ga-Pentixafor

o 68Ga-PSMA HBED

o 68Ga-HA DOTA TATE

o 68Ga-DOTATOC

o 68Ga-RM2

o 68Ga-Avebetrin

o 177Lu-Pentixather

o 177Lu-HA DOTA TATE

Pre-installed SOP´s

In accordance with Ph.Eur. requirements if applicable

Pre-installed SOP’s: Value. Added.

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Standard modules in the basic system

and user-specific additional modules as

well as customization to the requirements

of individual work stations make fineo

extremely flexible.

Adapts to your needs: Modular. Customizable.

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Your processes clarified: fineo Process Maps

QC Samples

o Choose your article.o Add any additional

information.

SAMPLE MANAGEMENT

ControlApproveRelease

READY TO USE

Print report

If results do not comply

Recording of Test Values

OOS MANAGEMENT

Prod. of in-house Products

o Choose your product (article).o Choose or define the corresponding

batch number.o Specify the quantity of your product.o Add any additional information you

want (storage, incoming date, etc.).

CHEMICALS AND STANDARDMANAGEMENT

SAMPLE MANAGEMENT

Testing

ControlApproveRelease

READY TO USESTORAGE MANAGEMENT

BATCH MANAGEMENT

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Your processes clarified: fineo Sample Management

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Formulations

READY TO USE

Tab Formulation

Quality Control of Instruments

o Choose a device.o Add the necessary measures (e.g.

calibration).o Create time points.

TE TIMETABLE

FORMULATION MANAGEMENT

o Define your formulation.

ControlApproveRelease

o Create your mixture.

Tab Mixtures

SAMPLE MANAGEMENT

ControlApproveRelease

READY TO USE

Report back

Control

Testing

MASTER DATA MANAGEMENT

Tab TE-Ojects Device

If a test values are needed.

Recording of Test Values

o Creation of additional time points

o Creation of ad-hoc time points.

Your processes clarified: fineo Process Maps

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Your processes clarified: fineo Formulations and Mixtures

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Your benefit: LIMB Experience. Radiopharmacy Know-how.

The power behind fineo is MAQSIMA, a joint venture of Certina IT AG and TÜV Saarland e.V., a leading provider

of LIMS systems and software solutions with more than 15 years comprehensive knowledge and competence in

the field of quality and safety management specifically to the pharmaceutical industry.

The right combination of SCINTOMICS radiopharmacy know how and MAQSIMA´s LIMS experience enabled us

to create fineo, the first Information and Management Software Package dedicated to routine workload in

Radiopharmacies at affordable costs.

Following SCINTOMICS´s philosophy, the aim was to create a user-friendly, essentially standardized, but still

customizable software that portrays the work flow in typical radiopharmacies while deliberately omitting

unnecessary complexity. Created by a team of laboratory experts, consultants and programmers it condenses

the experience gained from working with quality control laboratories of the pharmaceutical industry – and now

adapted, adjusted and filled with data for Radiopharmaceutical Laboratories.

Are you skeptical of LIMS systems ?

…then try

• Meets all requirements in daily laboratory life

• Maps laboratory processes realistically

• Guarantees security of collected data

• Operates intuitively and is user-friendly

• Makes laboratory work efficient and economic

All this, with the guarantee of meeting the strict provisions of GLP/GMP, ISO 9001 and ISO 17025. This combination results in a high level of acceptance from employees, customers and vendors and contributes to efficient work in laboratories.

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SCINTOMICS GmbH Global Radiopharmacy TechnologyLindach 482256 Fürstenfeldbruck / Germany

T +49 (0) 8141 150 55 - 0F +49 (0) 8141 150 55 - 15

info@scintomics.com

www.scintomics.com