Traceability for the pharmaceutical sector

Traceability in pharmaceuticals is crucial to ensure the safety, effectiveness and quality of products throughout their life cycle, from manufacturing to distribution and beyond. It involves establishing systems and procedures to track each product or batch of products through all stages of the supply chain.

Identification technologies


  • Use: Facilitates product tracking at each stage of distribution.
  • Advantages: Ease of reading by scanners and smartphones; contains information about batch, expiration date, etc.

Datamatrix & QR code

  • Usage: Similar to barcodes but can store more information in less space.
  • Advantages: Ideal for small packaging; supports partial degradation (can be read even if partially damaged).

RFID (Radio-Frequency Identification)

  • Use: Contactless tracking of products using electronic labels.
  • Advantages: Remote reading; storage of a large amount of information; real-time tracking.

IoT (Internet of Things)

  • Use: Sensors and connected devices for real-time monitoring of storage and transport conditions.
  • Avantages : Surveillance de la température, de l’humidité, etc., essentielle pour certains médicaments.

To find out more about the different identification technologies, consult our solution sheet dedicated to asset identification.

Issues and perspectives

The effective implementation of traceability solutions in the pharmaceutical environment is essential to combat counterfeit medicines, ensure patient safety and comply with strict industry regulations. Technological advances, such as AI, blockchain, and IoT, provide new opportunities to improve traceability. However, they require close collaboration between manufacturers, distributors, regulatory authorities and traceability solution integrators to be fully exploited.


Pharmaceutical traceability remains an evolving field, responding to new threats, regulatory requirements and technological advancements, while working towards the ultimate goal of protecting public health.

Focus on the GS1 UDI Standard

The UDI (Unique Device Identification) standard developed by GS1 is a universal coding system. It is used to uniquely identify and track medical devices throughout their lifecycle, from manufacturing to patient use. The UDI standard facilitates the interoperability of information systems in the health field. This standard aims to improve traceability, patient safety and management of medical devices by facilitating identification and data collection.


Main goals

  • Traceability of medical devices
  • Patient safety
  • Managing product recalls
  • Optimization of inventory management

Key components of the UDI standard

  • Device Identification Number (DI)
  • Device Data (DDI)
  • UDI marking
  • UDI Database

Benefits & impact

  • Improved patient safety
  • Strengthening traceability
  • Regulatory conformity
  • Optimized inventory management


The GS1 UDI standard represents a major advancement in the traceability and management of medical devices, providing significant benefits in terms of patient safety, regulatory compliance and operational efficiency. Its widespread adoption by manufacturers, distributors and healthcare providers helps improve quality of care and patient safety globally.

Focus on Qi/Qo/Qp

In the pharmaceutical sector, as well as other regulated industries such as biotechnology or medical devices, the concepts of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are crucial to ensure that installed equipment and systems operate and perform in accordance with pre-established requirements.

Achieving IQ, OQ and PQ qualifications is essential to:

  • Ensure compliance with international regulations and quality standards.
  • Minimize the risk of equipment failure, which can affect product quality and patient safety.
  • Provide documentation proving that equipment and systems are installed and functioning properly, facilitating regulatory audits.


In summary, the IQ/OQ/PQ process is a key element of validation practices in the pharmaceutical and related industry, ensuring that equipment and systems are not only capable of producing high quality products but also comply with strict regulatory requirements.

Focus on NiceLabel software

NiceLabel is software for label design and management of label printing systems. Widely used across various industries, it allows businesses to quickly and easily create custom labels while complying with regulatory standards and specific industry requirements.


Main features

Label design

  • Simplified and accessible user interface
  • Compatible with a wide range of barcodes and QR Codes
  • Integration of variable data: databases, Excel sheets, ERP systems, to automate label printing.

Label printing management

  • Centralized printing: allowing you to control printers distributed across several sites.
  • Security and Control: Advanced access control and auditing features to ensure that only authorized users can design, modify or print labels.


Regulatory conformity

  • Pre-designed templates: Library of label templates that comply with international regulations, reducing the risk of errors and facilitating compliance.
  • Label management: Effective management of label versions and revisions to comply with regulatory requirements for documentation and traceability.
  • 21 CFR PART 11: United States Food and Drug Administration (FDA): ensuring the integrity, confidentiality and availability of electronic records, permitting the use of electronic signatures as the legal equivalent of handwritten signatures, promoting the adoption of electronic technologies in the pharmaceutical industry and other regulated sectors.

Benefits for regulated industries

  • Security and compliance
  • Efficiency and cost reduction
  • Flexibility and scalability


NiceLabel is a robust and flexible solution for label design and management, providing significant benefits in regulatory compliance, operational efficiency and quality control. Its adoption in regulated industries, such as the pharmaceutical sector, can significantly help minimize the risks of non-compliance while optimizing production and distribution processes.

Need a traceability solution in the pharmaceutical, medical or any other regulated industry? Need a traceability solution that meets industry standards?

CIPAM supports you in implementing regulated traceability solutions that comply with sector requirements.

  • Encartonnage & palettisation de dispositifs médicaux
    Encartonnage & palettisation de dispositifs médicaux