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EU Regulatory Compliance

EU regulatory compliance European Union Falsified Medicines Directive (EUFMD) Regulation Following adoption by the European Council and the European Parliament,

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Systech selected by Praxis Packaging for track and trace solutions

Systech, a part of Markem-Imaje and Dover and a leading provider of digital traceability, serialization and compliance solutions for the pharmaceutical industry, is proud to announce its selection by Praxis Packaging Solutions to provide a track and trace platform for supply chain transparency. This collaboration offers Praxis customers access to world-class aggregation and enhanced product tracing to swiftly meet global compliance requirements such as the FDA-mandated DSCSA (Drug Supply Chain Security Act) regulation with a November 2024 enforcement deadline.

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Packaging Optimization

Packaging line optimization for improved efficiency and performance Systech offers a productized software suite that quickly gives manufacturers complete control

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Systech unveils turnkey solution for pharmaceutical rework and manual aggregation

Systech, a part of Markem-Imaje and Dover and a leading provider of digital traceability, serialization and compliance solutions, is proud to launch a turnkey manual aggregation and rework solution for pharmaceutical manufacturers, CMOs, CDMOs, repackagers and wholesalers. It is the first integrated offering following Systech’s acquisition of Pharmacontrol Electronic GMBH (PCE) earlier this year.

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UniTrace Hub | Systech

Expiry Recalls UniTrace Mobile DSCSA Exceptions Manager ATPs Hub Master Data UniTrace Collaboration Hub Centralized Router The UniTrace Collaboration Hub

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UniTrace Mobile | Systech

Expiry Recalls UniTrace Mobile DSCSA Exceptions Manager ATPs Hub Master Data UniTrace Mobile Leverage the functionality of Systech’s UniTrace traceability

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Expiry Management | Systech

Expiry Recalls UniTrace Mobile DSCSA Exceptions Manager ATPs Hub Master Data Expiry Management — Simplified. Customized. Systech’s UniTrace® system reduces

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Clinical trials for IMPs

Ensure label accuracy for clinical trial investigational medicinal products Meet the rigorous labeling requirements associated with clinical trials for investigational

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Unlocking efficiency: How to tackle exceptions with supply chain rework

Exceptions Management focuses on identifying and resolving issues arising during pharmaceutical product manufacturing and distribution. It is critical in the pharmaceutical sector due to patient safety and regulatory compliance and to avoid supply chain delays and product quarantine.

Our experts will delve into the intricacies of exception management and rework within the pharmaceutical supply chain with real world case studies and success stories.

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Recursos (EN)

Knowledge center Tap into these informative resources to help meet your objectives in digitalization, regulatory compliance and supply chain transparency.

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Tackling pharmaceutical supply chain challenges

Systech’s Dave DeJean writes about the various challenges faced by the pharmaceutical supply chain and how embracing technological innovation and collaborative strategies is the way forward for improving distribution efficiency and security.

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Systech launches innovative exception handling and rework solution

Systech, a part of Markem Imaje and Dover and a leading provider of digital identification and traceability software solutions, today announced that it has released the next generation of its UniSecure® platform, a comprehensive product security solution for counterfeit and diversion detection. UniSecure provides unique product identification, traceability and product verification via smartphone across the supply chain in the pharmaceutical, nutraceutical, medical products, skin care and other markets.

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Cookie Policy

Last Updated: February 2024 Systech International Cookie Policy Our Site uses cookies and/or similar technologies such as device IDs, pixel

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SHARP

Case Study | Sharp Partners with Systech For a Non-Additive Product Authentication and Supply Chain Security Solution “We went all in

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Systech Launches a Breakthrough in Product Security

Systech, a part of Markem Imaje and Dover and a leading provider of digital identification and traceability software solutions, today announced that it has released the next generation of its UniSecure® platform, a comprehensive product security solution for counterfeit and diversion detection. UniSecure provides unique product identification, traceability and product verification via smartphone across the supply chain in the pharmaceutical, nutraceutical, medical products, skin care and other markets.

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Systech completes SOC 2 Type II audit

Systech, a Markem Imaje and Dover company, today announced that it has successfully completed a System and Organization Controls (SOC) 2® Type II Audit examination. The successful completion of this voluntary audit illustrates Systech’s ongoing commitment to creating and maintaining a secure operating environment for its customers’ confidential data.

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Systech Blog

Systech blog Solve your compliance, authentication and traceability challenges with industry insights on the latest packaging and supply chain advancements.

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What is DSCSA Compliance?

DSCSA compliance requires that drug manufacturers, dispensers, and distributors (basically all stakeholders in the pharmaceutical supply chain) follow certain federal

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NABP Pulse and Systech – A winning DSCSA platform combination for dispensers

Systech announced recently that it joined the National Association of Boards of Pharmacy (NABP) Interoperable Partner Program, Pulse by NABP. This is important news as both Systech and NABP want to ensure that pharmacies and dispensers are ready for DSCSA (Drug Supply Chain Security Act) compliance this November. Though a stabilization period has been granted by the FDA, the November 27, 2023 date is still the legal target for the industry. 

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DSCSA exception management for dispensers: Is your process ready?

As part of the FDA’s Drug Quality and Security Act, one key rationale for the Drug Supply Security Act (DSCSA) was to protect US patients from receiving counterfeit or illegitimate medications. Everything the industry is doing to connect manufacturers, wholesalers and dispensers to create an interoperable supply chain is all about patient safety.

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Is your pharmacy ready for DSCSA exception handling? 

The receiving process for totes at pharmacies from wholesalers hasn’t changed much over the past 25 or more years.… Physical packages reconciled to a printed manifest/order. Quantities checked. Verification that nothing is damaged. Inspection to see if anything is already expired. Data entry into a pharmacy inventory system. Even if there are some issues, the medicines get put into stock. 

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Quem somos

Who we are Established in 1985, Systech is the leader in providing digital identification and traceability solutions. Our offerings establish

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Sistemas de Visão

Packaging verification and vision inspection In today’s dynamic manufacturing environment, you need your product packaging to be rock-solid reliable. Systech’s

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What is anti counterfeiting?

Applying protections to packaging and establishing monitoring programs to combat counterfeit or harmul products from entering the supply chain https://www.youtube.com/watch?v=BnQXPa15K-w

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What Is GAMP?

Good automated manufacturing practice (GAMP) is a set of guidelines for manufacturers and other automation users follow to maintain operational

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What is dscsa compliance?

DSCSA compliance requires that drug manufacturers, dispensers, and distributors (basically all stakeholders in the pharmaceutical supply chain) follow certain federal

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What is aggregation?

Aggregation is a technique used in conjunction with serialization that establishes and records the relationship between a serialized object and

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What Is DCSCA?

What is DCSCA? Drug Supply Chain Security Act: As defined by the FDA, outlines steps to achieve interoperable, electronic tracing

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What is Brand Protection?

A corporate program that safeguards brand reputation and consumer trust through IP protection through anti-counterfeit and diversion detection plus online

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Consumer Goods

Fake products… real risks! Don’t let counterfeiters benefit from your hard fought brand promise and endanger your customers. Systech can

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Nutraceuticals

Nutraceuticals: Protecting your products across the supply chain You’ve worked hard to earn customer trust and loyalty. Systech helps keep

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Medical Devices

Medical devices: Tackling the global supply chain threats of counterfeiting and diversion In the fast-paced world of healthcare, ensuring the

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Pharmaceuticals

Pharmaceuticals: Delivering value to the industry for 35+ years Systech provides proven inspection, serialization, traceability and authentication solutions. The world’s

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GLOSSÁRIO (EN)

Glossary Industry Terms What is DSCSA compliance? What is serialization pharmaceutical packaging? What is brand protection? What is anti counterfeiting?

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Pharmaceutical Compliance

Pharmaceutical compliance… We understand what it takes Systech offers powerful serialization and traceability functionality to help you meet global pharmaceutical

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Solution Page

Your brand matters. Protect it. Together, our solutions offer the strongest, most cutting-edge brand protection for your products as they

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Typography

H1 – You brand matters. Protect it. H2 – Together, our solutions offer the strongest, most cutting-edge brand protection for

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Contate-Nos

Contact us Systech is here for you. Let us know how we can help. Request information General information General Inquiries

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Aggregation isn’t “mandated” for DSCSA but it is required

Many major wholesalers are leading the charge for receiving aggregated data—requiring that manufacturers be able to digitally send pallet identifiers with corresponding digital details of all shipments sent to them. Without this data being aggregated, wholesale staff would have to open each pallet and manually scan each serialized product.  

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Markem-Imaje Acquires Blue Bite

Expands portfolio of software solutions serving product identification, traceability, authentication, and consumer engagement applications Markem-Imaje, an operating company of Dover

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