LEVEL 1 TO 5 SOLUTIONS FOR PHARMA SERIALIZATION.

Keep track on all regulations with Traxeed

United States of America

  • Serialization (11.2018)
  • Aggregation (11.2023)
  • GS1 Datamatrix

Brazil

  • Serialization (12.2021)
  • Aggregation (12.2021)
  • GS1 Datamatrix

Argentina

  • Serialization (06.2012)
  • Aggregation (not req.)
  • GS1 Datamatrix

Turkey

  • Serialization (01.2010)
  • Aggregation (11.2012)
  • GS1 Datamatrix

India

  • Serialization (01.2013)
  • Aggregation (04.2016)
  • GS1 Datamatrix, Code 128

Saudi Arabia

  • postponed (no new date)

China

  • Serialization (12.2015)
  • Aggregation (12.2015)
  • Code 128

South Korea, Republic of Korea

  • Serialization (01.2015)
  • Aggregation (not req.)
  • GS1 Datamatrix, Code 128

Russia

  • Serialization (01.2020)
  • Aggregation (01.2020)
  • GS1 Datamatrix

Japan

  • Serialization (04.2021)
  • Aggregation (04.2021)
  • GS1 Databar Composite

Egypt

  • Serialization postponed >2018

Pakistan

Pakistan

  • Serialization (6.2018)
  • Aggregation (6.2020)

Bahrain

  • Serialization (Q2.2019)

Indonesia

  • Serialization (Q3/2020)

Lebanon

  • Serialization (1.2020)

Europe

  • Serialization (12.2019)
  • Aggregation (not req.)
  • GS1 Datamatrix

Read more

More information on EU FMD February 2019

It's time to serialize for Europe

Ensure unique identification and tracking

Printing + verification

Coding of the sales unit with variable, production-related data (e. g. batch number, expiry date) and verification of the printed information.

Serialization

Coding of the sales unit with serial number and variable data plus verification of the printed information.

Serialization + aggregation (e-pedigree)

Seamless tracking in the supply chain and evidence of origin through serialization and aggregation (an electronic ‘family tree’) extending across every level of packaging.

Get all relevant products & services from a single source

We are by your side from the start of the project to commissioning, ensuring the success of your project.

One for all

Serialization advice

Statutory regulations and requirements - with the help of our experts you meet every requirement and implement your project.

Software & hardware development

New regulations, changes to technical requirements – we react immediately and adapt our products.

Overall project management

We are by your side - from concept through to global rollout.

Set-up & integration

Minimum line downtime for set-up/integration - thanks to the use of our standardized, pre-tested products.

Documentation

All documents accessible at all times in accordance with GAMP5 regulations.
GAMP5 - all documents accessible at all times.

Testing & process optimization

Planning, execution or support during production – we optimize your Track & Trace processes.

Service & support

Training, lifecycle management and optional 24/7 support - select the service which suits you.

Make use of specialist know-how

Reliable Track & Trace solutions

Our Track & Trace solutions, developed by Seidenader, label every salable unit with a code that includes a serial number, and with a tamper-evident seal if desired. Items can be aggregated into the next level of packaging.

We offer system solutions from level 1 to level 3 in accordance with ISA-95. Regarding machine vision, we offer Seidenader Vision as well as Cognex Smart Cameras.

The Traxeed Level 2 serialization solution includes sophisticated software packaged with strategic machines and workstations to meet the markets demands in packaging. In addition, on level 3, different lines can be easily managed via a central administration.

The provisioning of serial numbers, notifications of completed serialized data is happening in exchange with Level 4 & 5. These include, but are not limited to Werum, Arvato CSDB, or SAP.

In accordance with applicable regulations

Based on the knowledge of our Systec & Services experts, Traxeed offers Track & Trace solutions for the pharmaceutical industry that enable companies to structure their production processes from level 1 to level 5 in accordance with applicable laws.

In particular, small and mid-sized companies are confronted with the challenge of having to serialize their products under time constraints. Traxeed offers consulting services in this regard and develops strategies and solutions across all systems. 

We supports pharmaceutical companies in implementing the solutions – on the supplier’s page as well as at the pharmaceutical company’s site.

We look forward to finding the optimal solution for you.

Your personal contact will gladly answer your individual questions. Call us. Or contact us using the contact form.

Contact us!

Traxeed

Phone: +49 721 6634 330

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