PROJECT INTRODUCTION FOR UTS PROJECT -...

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TÜBİTAK-BİLGEM- Software Technologies Research Institute 1

PROJECT INTRODUCTION FOR UTS PROJECT

27 November 2015

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Overview of the Project Definition of the Project

Purpose of the Project

Project Attainments Scope of the Project

Status of the Project Activities for Expansion of the Project

Presentation Subjects

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Overview of the Project

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Through this Product Tracking System (UTS) Project, it is targeted to develop a substructure for the purpose of tracking all medical devices and cosmetic products manufactured whether domestically or imported, including their production line, places to where they are sold and/or areas in which they are used.

This developed System (Product Tracking System) is an e-state application with hundreds of users which provides citizen-oriented services.

Definition of the Project

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Medical Device

~4 million product types

(Billions of Singular Products)

Cosmetics

~400,000 product formulas (Billions of Singular

Products)

To record medical devices and cosmetic products

To install a National and Unique substructure in order to track the products and which is suitable for their performance requirements

To contribute into the protection of public health and provision of patient security

To provide a substructure for the performance of auditing services in a healthy and effective manner.

To ensure that quick measures are taken against any dangers that may arise during the use of products.

Purpose of the Project

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Project Attainments

Access to Safe Product

Active Control

Determination of Health Policies

Struggle against Informal Economy

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Project Attainments

Identification and recall of expired or unsafe products

Taking the border entries and the product movements of the medical devices and cosmetic products under control

Tracking the calibration, maintenance and repair procedures of the medical devices through a single system

Providing an opportunity for the development of health policies through up-to-date information

Preventing any deficiencies occur in the medical device payments which are resulting from lack of information on the product

Taking measures in a short period of time against any dangers that may arise during the use of medical devices and cosmetic products

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Scope of the Project

Track and TraceProduct Movements Module

Product Recall Module

Product Management Product Tree Management Module Product Management Module

User, Institution and Authority ManagementUser Management ModuleInstitution Management ModuleAuthority Management Module

Clinical EngineeringMaintenance and Repair Management ModuleCalibration Management ModuleTechnical Staff Certification ModuleTechnical Service Management ModuleCalibration Organization Management Module

Business IntelligencePredefined Reporting ModuleMap-Aided Reporting Module

Market Surveillance and Control (MSC) and Warning

Controlling Activities ModuleWarning Module

Supporting FunctionsDocument and Certificate

Management ModuleReference Areas Module

Log Management ModuleAnnouncement Module

Scheduled Tasks Module

Citizen–Oriented ServicesProduct Query Module

Product Query Module for Individually Registered Products

Complaints Reporting Module

Modules(8 Module Groups)

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TÜBİTAK-BİLGEM-Yazılım Teknolojileri Araştırma Enstitüsü 9

Overview of Product Tracking System (UTS)

TITCK

Citizen

Controlling the product records and documents

Distributor/Storage

Performance of the auditing and recall activities Inquiry of registered products

TITCK

Place of Sale/ Implementation

Product ManagementRecording the products together

with their documents

Audit

Risk- oriented auditing and recall transactions

Business Intelligence

Clinical EngineeringMaintenance, repair and

calibration procedures of the products

Product Movements

Manufacturer/importerBeing able to carry out the tracking and tracing of the

singular products

Providing an active reporting and decision support mechanism

Adding the product movement notifications to the system

Adding the sale and usage notifications of the products

Sending the production/ importation notifications to the

system

Manufacturer/importer Adding the documents and

product records to the system

(Turkish Medicines and Medical Devices Agency)

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10

Product Management

Registered Product

Registered Product

TITCK Controls the Product Record

TITCK Controls the Product Record

Manufacturer / Importer Company Adds the Product

Record

Manufacturer / Importer Company Adds the Product

Record

TITCK Controls these Documents

Manufacturer / Importer Company Adds the Document

Manufacturer / Importer Company

Adds Formula

Medical Device

Cosmetics

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Singular Product Identification

Serial Number

LotNumber

= Singular Product

+ +

Singular Product Identification

= Barcode Number

Barcode No: 8691234567890Serial No: 12375647300127398294Lot No: 234Date of Manufacture: 31.12.2013Date of Expiry: 31.12.2015

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Tracking Based on Lot and Singularity

Singular Product

Group of Singular Products

Singularity-Based Tracking

Lot-Based Tracking

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Traceability of Singular Products

Tracking and tracing singular products24/7 and throughout the whole process

Variable routes in the product movements

Different movement types andbusiness rules

Joint system variety and number

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14

Auditing Process through UTS

CosmeticsMedical Device

Poisoning Incident Reporting

Risk-Based Audit

Risk-BasedAudit

Complaint/Negative Incident Reporting

Complaint/Negative Incident Reporting

Product Recall

Audit ReportAuditing Services(TITCK)

Product Recall

Stopping Device Usage

Audit ReportAuditing Services(TITCK)

Company Information

Product Information

Product Movements Information

Past Audit Reports

Company Information

Product Information

Product Movements Information

Past Audit Reports

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Clinical Engineering Processes

* Scenarios shall be developed according to Clinical Engineering Law to be published.

Up-to-Date Maintenance/Calibration Time

Upcoming Maintenance/Calibration Time of the

Device

Maintenance/Calibration Form

Approved Maintenance/

Calibration Form TITCK

Hospital

Social Security

Institution (SSI)

Calibration, Maintenance and

Repair Times of the Medical Devices

UTS Medical Device Maintenance/

Calibration Warning

Authorized Person for Maintenance/

Calibration

Authorized Person forClinical Engineering

TITCK Hospital Social Security Institution (SSI)

Dat

a En

try

App

rova

l

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Institution, User and (Dynamic) Authority Management

Pool of Authority

Authority l

Authority 2

Authority 3

Authority -

Authority n

TITCK Authorized User

Authorized User for Place of Production

Authorized User for Place of Sale

Authorized User for the Public

Institution

Authorized User

Users and User Groups




Authority l

Authority 2

Authority 5

Authority 7

Authority l

Authority 5

Authority 71

Authority 118

Authority 12

Authority 13

Authority 15

Authority 77

Authority ..

Authority ..

Authority ..

Authority ..

Kuru

mla

r ve

Kur

um K

ulla

nıcı

ları

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Business Intelligence

SECTOR To be able to reach comprehensive information regarding the singular products

CITIZEN To be able to reach information on the safe product

AUDIT TEAMS To provide active contribution

into risk-based recall and audit activities

TURKISH REPUBLIC MINISTRY OF HEALTH

To contribute into determination of effective health policies

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Citizen-Oriented Services

REGISTERED PRODUCT

REGISTERED PRODUCTÇiçek Special No:5

Location: ÇİÇEK Cosmetics

ANKARA - Çankaya


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UNREGISTERED PRODUCT

UNREGISTERED PRODUCT


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PRODUCT IN THE WRONG LOCATION

REGISTERED PRODUCTÇiçek Special No:5

Location: PAPATYA Kozmetik ANKARA - Çankaya


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21 TÜBİTAK-BİLGEM- Software Technologies Research Institute

UTS Users

PRODUCT MANAGEMENT PRODUCT MOVEMENTS

• Manufacturer and Importer Companies • Manufacturer and Importer Companies• Distributors / Storehouses

• Places of Use• Places of Sale

• Public Institutions• Public Institutions

• Medical Device Manufacturers / Importers

• Cosmetics Manufacturers / Importers

• Turkish Medicines and Medical Devices Agency (TITCK)

• Social Security Institution (SSI)

• National Poison Information Center (UZEM)



• Turkish Public Hospitals Agency ( TKHK)

• Turkish Public Health Agency (THSK)

CLINICAL ENGINEERING MARKET SURVEILLANCE AND CONTROL (MSC)

• Maintenance and Calibration Companies

• Public Institutions

• Public Institutions



• Turkish Public Hospitals Agency ( TKHK)

• Turkish Public Health Agency (THSK)

• Turkish Atomic Energy Authority (TAEK)



• Turkish Republic Ministry of Economy

• Turkish Republic Ministry of Customs and Trade

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Integrations

1 6 System Integrat ions

GMDN

MERSIS ESBISMerchants and

Craftsmen Information

System

HBYS

MEDULA

EUDAMED

MERNISCentral

Population Registration

System

MKYS

National MSC Database

VEDOP E-StateE-State Office

EKAP

EUDAMED CPNP

TITCK EBYS

National MSC Database

Market Surveillance and Audit

TITCK EBYS

e-Pulsee-Pulse Portal

e-Pulsee-Pulse Portal

Hospital Information

Management System

Material Resource

Management System

CKYS

Core Funding Management

System

Central Registry System

Electronic Information

Management System

Tax Office Automation

Project

Global Medical Device

NomenclatureMarket

SurveillanceAnd Audit

The European Databank on

Medical Devices

Medical Messenger

Electronic Public Procurement

Platform

Electronic Information

Management System

Cosmetic Products Notification Portal

The European Databank on

Medical Devices

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Status of the Project

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Contract and Project Calendar

2014 2015 2016

Preliminary Analysis and1st Workshop

Business and SoftwareAnalyses and Design

HA Architectural Designand Developing

User, Institution andAuthority Management

Product Management Tracking and Tracing

• Supportive Functions• MSC and Warning• Business Intelligence

• 2nd and 3rd Workshops• Training• Expansion

• Citizen OrientedServices

• Clinical Engineering

• 4th and 5th Workshops• Training• Expansion

January 2014

Contract

7 January 2014

2017

• System’s TemporaryAcceptance Activities

• System’s FinalAcceptance Activities

• Expansion

May 2017

Closing

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Project Calendar and Modules

2014

2015

2016

2017

• User Management Module• Institution Management Module• Authority Management Module• Document and Certification Management Module• Reference Areas Management• Log Management Module

Completed Modules

• Product Movements Module• Product Recall Module• Auditing Activities Module• Warning Module• Predefined Reporting Module• Product Query Module• Product Query Module for Individually Registered Products

Completed Modules

Ongoing Modules

• Product Management Module• Product Tree Management Module• Announcement Module• Scheduled Tasks Module

• Maintenance and Repair Management Module• Calibration Management Module• Technical Staff Certification Module• Technical Service Management Module• Calibration Institution Management Module• Maintenance Calibration Query Module• Complaint Reporting Module• Map-Aided Reporting Module

Planned Modules

• System’s Temporary Acceptance• Expiration Date based on Final

Acceptance• Final Acceptance

Planned Works

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Current Status (November 2015)

Temporary Acceptance is completed

Current Status of Product Tracking System (UTS) Project

10 Modules 7 Modules 8 ModulesStill in process of

developmentDevelopment process

will start

*As of November 2015

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Project Expansion Activities

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Number of Groups: 5

Number of Total Participants: 54

Type of the Training: Hands-on Training

Place of the Training: YTE R&D Building / Ankara

End User Trainings

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26-27 November 2015, Istanbul

~200 participants

3rd Workshop for UTS Project

Workshops Sessions Name of the Session

1st Session (26 November) Places of Use for the Medical Devices

2nd Session (26 November) Places of Sale and Wholesalers for the Medical Devices

3rd Session (26-27 November)

Manufacturers, Importers, Wholesalers and Places of Sale for Cosmetics

4th Session (27 November) Medical Device Manufacturers and Importers

5th Session (27 November) Technology Teams

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5-8 May 2015, Eskisehir

~125 participants (16 Public Institutions + 27 NGOs)

2nd Workshop for UTS Project

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10-12 September 2014, Abant

~150 participants (16 Public Institutions + 22 NGOs)

1st Workshop for UTS Project

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12 March 2015, Ankara

The functionality developed in scope of Product Management Module of Product Tracking System (UTS) Project was introduced.

Meetings with the Industry

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UTS Portal

Announcements about education and trainings on the project, analysis meetings and up-to-date information are published via this portal.

http://uts.saglik.gov.tr/

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THANK YOU

Çukurambar Mah. 1478. Cadde No:22 06100 Çankaya / ANKARA +90 (312) 289 9 222

[email protected] http://yte.bilgem.tubitak.gov.tr/

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