Compliance and Digital Information Platform for Pharmacies with EU FMD Requirements

Under EU FMD, pharmacies across the region must now scan a new 2D DataMatrix barcode (containing GTIN/NTIN, serial number, lot number, expiry, and optional National Reimbursement Code), which is applied by the manufacturer to every pack of medicines, and verify the authenticity against information held in a national system.

The TraceLink Compliance and Digital Information Platform for pharmacies with EU FMD requirements allows dispensers to meet their verification and decommissioning requirements under the law without any disruption to existing workflows.

Pharmacists simply use a mobile device to scan any prescription medicine and submit the product code (GTIN/NTIN), serial number, lot number, and expiry date with the verification or decommission request, and the application will receive the status from the national system.

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Redefining GxP processes with complete validation automation

Staying 100% compliant requires staying on top of ongoing change within the pharmaceutical supply chain. Evolving legal and industry standards. Trade partner requirements. Software and system updates.

Even the smallest modification to your track and trace ecosystem—and the need to validate your systems after every change—can impact your ability to stay compliant and deliver your product to patients.

TraceLink Automated Validation Manager (AVM) automates the entire validation life cycle of the TraceLink Life Sciences Cloud, with automatic testing and confirmation to ensure all current TraceLink software capabilities meet GxP compliance in accordance with industry standards such as GAMP 5.

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Global track and trace solutions are now a necessity
for every Life Sciences company.

By 2018, over 40 countries and more than 75% of global medicine supply will be covered by one or more track and trace regulations. Companies serving global patients face complex serialization, traceability, verification and government reporting regulations.

Meeting regulations from the U.S. and EU to China and Brazil requires not just preparing your company but also connecting to and coordinating with your diverse supply network of CMOs/CPOs, pharma companies, wholesalers, pharmacies and government agencies.

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Global Track and Trace

Serialization. It may be one of the biggest operational challenges
that your company has ever faced.

Companies face massive challenges in dealing with the growing diversity and complexity in pharmaceutical serialization requirements. Unique product identifiers vary across countries, serial number formats diverge from global GS1 standards into country-specific versions (China, Brazil, etc.) and aggregation creates complex data management issues.

Ensuring serialized products get to market demands a comprehensive global strategy and supporting network IT architecture. Starting early is crucial.

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Global Serialization

External manufacturing is now a way of life in the global supply network.

Outsourced manufacturing and packaging is a strategic part of today's Life Sciences supply network operations. With over 40% of today's pharmaceutical production estimated to be done by CMOs and CPOs, high performance collaboration with supply partners is crucial.

This requires rethinking how pharmaceutical companies work with their external manufacturing partners. The goal should be to have the same level of visibility, coordination and control across the external manufacturing process that companies have throughout their own production assets and sites.

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External Manufacturing

How you manage quality with external suppliers can make or break your business.

The complexity of a company's supply network has exploded in recent years as businesses not only leverage external manufacturing partners but also search the world for the best suppliers of materials ranging from active ingredients and excipients to packaging bottles and paper clips.

Ensuring the quality and reliability of these suppliers and the products they provide is paramount in the highly regulated Life Sciences industry as you produce and distribute life saving medicines to global patients. You need visibility and control over these sources.

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Supply Quality Management

Mobile isn't just a device.
It is a new way of connecting to patients, processes and information.

Keeping patients safe from counterfeit drugs while supporting their health with medicines and information is crucial. Reaching the patient whether they are in the United States or Uganda is a particular challenge given complicated global supply chains and traditionally limited ways of communicating knowledge.

The explosion of mobile devices ranging from smart phones to tablets present a unique opportunity to transform the relationship with the patient, enabling companies to establish a true bi-directional conversation with patients and care givers.

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