Today, pharmaceutical companies are often encountering significant challenges such as increasing regulatory demands, the risk of counterfeit drugs and supply chain disruptions. To address these challenges, many companies are implementing advanced track and trace technologies to strengthen their supply chains. This checklist will help you align your systems with regulatory requirements and enhance the success and resilience of your entire supply chain — a critical competitive advantage for any pharmaceutical company.

1. Regulatory compliance

• Is your track and trace system fully compliant with the EU Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA)?
• Have you implemented item-level serialization for all relevant products?

Why it matters: Regulatory compliance helps to mitigate risks and fosters trust with regulators and customers. Companies that proactively meet industry requirements minimize the likelihood of penalties and maintain industry leadership.

2. Ensure maximum transparency across the supply chain

• Do you have real-time, end-to-end visibility across your entire supply chain?
• Can you seamlessly track the journey of each product from manufacturing to end-user?

Competitive advantage: Transparency means control. Companies that monitor their supply chain in real time can respond more quickly to unforeseen events and increase efficiency. Harness the power of information.

3. Monitor cold chains seamlessly

• Do you use track and trace tools to monitor temperature-sensitive products?
• Have you set up an early warning system that sounds the alarm immediately in the event of deviations in the cold chain?

Trust advantage: Customers trust companies that guarantee the highest quality. By ensuring optimal conditions for temperature-sensitive products, you demonstrate expertise and diligence.

4. Protection against counterfeiting

• Is your track and trace system equipped with e-Fingerprint® or similar authentication technology designed to prevent counterfeiting?
• Have you tested the system for its ability to detect and report counterfeit products in real time?

Security advantage: Counterfeit-resistant systems help increase trust in your brand and can provide protection against illegal copies. Consumers want safe and authentic products.

5. Data security and data protection

• Does your system comply with applicable data protection regulations (e.g. GDPR)?
• Have you implemented secure data encryption and role-based access rights to protect sensitive information?

Established trust: Companies that take the protection of sensitive data seriously can gain the trust of partners and customers. Data security is no longer optional—it is a must.

6. Make your system scalable for future growth

• Can your track and trace system easily handle future growth and new legal requirements?
• Is your system built on a modular architecture that allows for quick adjustments?

Sustainable success: Companies that use scalable solutions are optimally prepared for future growth. They help ensure flexibility, which is essential in a dynamic industry.

7. Ensure seamless integration with partners

• Does your track and trace system support seamless integration with logistics and retail partners?
• Can you efficiently exchange serialization data with all supply chain participants?

Shared success: A well-integrated supply chain creates synergies that help everyone involved. By working with partners, you can improve your processes and reduce errors.

8. Ensure efficient handling of rework and exceptions

• Have you set up processes to manage rework after production and exceptions in your track and trace system?
• Are all events (e.g. returns, rework) captured and tracked in real time?

Optimization benefit: Companies that quickly correct and efficiently track errors minimize failures and optimize production. This improves transparency and trust in your brand.

A strong and reliable supply chain is no longer just a goal—it is crucial for success in the global pharmaceutical industry. Companies that utilize an effective track and trace system not only achieve compliance with regulations but can also build trust with their customers and partners. By following the steps outlined in this checklist, your company can minimize risks, enhance operational efficiency and be ready for future growth.

Why Systech is the right partner for you

Systech combines state-of-the-art track and trace technologies with decades of experience working with the world’s leading pharmaceutical companies. We offer:

• Proven experience and trust: More than 16 of the world’s largest pharmaceutical companies rely on our solutions, demonstrating our unmatched expertise and reliability
• Scalable, future-proof solutions: Our modular systems quickly adapt to evolving regulations, ensuring that your supply chain remains flexible and resilient
• Innovative technologies: From integrated vision inspection to e-Fingerprinting, we go beyond compliance to help protect your brand and build lasting trust in your products
• Partnered support: We work closely with you to deliver tailored solutions and long-term support—from seamless implementation to ongoing optimization

Systech, the partner that helps ensure your sustainable success and growth in today’s complex pharmaceutical world. Entre em contato conosco today to speak with an expert.