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The Importance of Serialization Standards

In the pharma industry, time is money. Delayed deployments and postponed launches of a serialized product can result in the loss of thousands—even millions—of dollars. Based on GS1’s global standards, OPTEL’s Verify Platform is a flexible serialization solution that has the technical capabilities, features and functionality you need.

Serialization for Russian Federal Law No. 425-FZ

As a leader in serialization and traceability solutions for a variety of industries, OPTEL is well positioned to help pharmaceutical companies comply with Russian Federal Law No. 425-FZ (decree No 1556), which states that in order to track supply chain activity, certain pharmaceutical products must be serialized by January 1, 2020.

OPTEL IMPLEMENTATION OF MEDILEDGER VRS IN PROGRESS

As you may know, the “Big 3” pharmaceutical distributors that handle most of the drug distribution in the United States (Cardinal Health, McKesson, and AmerisourceBergen) will not accept non-serialized returned products, also known as saleable returns, after November 27, 2019.

Cocoa

TRACEABILITY FOR THE BENEFIT OF COCOA

by Pierre Courtemanche, OPTEL Group, May 2019

I recently took part in the World Cocoa Summit in Guayaquil, Ecuador, which welcomed 500+ attendees, including eminent producers, traders, providers, exporters and government officials in the cocoa industry.

Food safety

Post-outbreak food safety rules validate need for supply chain traceability

In January 2019, the government implemented the Safe Food for Canadians Regulations (SFCR) with the goal of making the food system safer “by focusing on prevention and allowing for faster removal of unsafe food from the marketplace.”

Traceability: Implementing Tracks for Transparency

Traceability: Implementing Tracks for Transparency

Find out how to successfully collect data, increase communication and achieve full transparency along the supply chain, which is only possible when end-to-end traceability is in place.

Profiling Producers to Better Support Them

Profiling Producers to Better Support Them

Discover how profiling your producers based on set criteria is an efficient way to better support them and monitor the impacts of your interventions, and learn about our User Story feature in our web platform.

5 key things to consider when purchasing a technology system

5 key things to consider when purchasing a technology system

With plenty of apps and digital devices out there that offer all kinds of features and possibilities, making sure that a system really does meet your requirements has become a bit overwhelming. Learn how to purchase a technology system suited to your needs.

OPTEL’S TRACEABILITY EFFORTS TO MAKE MINERAL SUPPLY CHAINS SECURE AND SUSTAINABLE

A few weeks ago in Paris, I attended the OECD’s 13th Forum on Responsible Mineral Supply Chains with Ken Fallu, OPTEL’s Director of Business Development for the Mining Sector. This annual event was particularly interesting for us as it brings together industry stakeholders to discuss how to measure impact and drive change, as well as opportunities and challenges related to specific minerals.

UN Environment Assembly sees innovation as the way to #SolveDifferent

The time has come for a global collaborative effort to come up with sustainable solutions to some of the world’s most pressing environmental, social and economic problems.

Intelligent Supply Chain (ISC)

END-TO-END TRACEABILITY: A NEW COMPETITIVE ADVANTAGE

Corporate scandals such as counterfeiting, contamination and cheap labor exploitation threaten patient safety in the healthcare industry and consumer safety in the food and beverage industry, changing end-user behavior across the globe.

NOT HAPPY WITH YOUR SERIALIZATION SOFTWARE?

Serialization deadlines in the U.S. and European Union have finally passed. Now what? As serialization mandates become increasingly complex, pharmaceutical companies are scrutinizing whether their current serialization software is the best long-term solution.

AVOID RECALLS AND PROTECT YOUR BRAND WITH HD PRINTSAFE

Recent revelations surrounding the safety of medical devices has prompted government and industry players to ask tough questions about how best to regulate these healthcare products and how to better manage product recalls.

SURVEY SAYS MOST F&B INDUSTRY PLAYERS USE TRACEABILITY TO FIGHT FOOD FRAUD

The majority of industry players turn to supply chain traceability systems as the most trusted tool to fight food fraud, a new pan-Canadian survey suggests.

WHY A ZERO-WASTE SUPPLY CHAIN IS THE NEW NORMAL

When food is wasted, there is collateral damage. When land is not used to produce food, fertilizers, compost, seeds, water and labor is wasted. Manufacturing production lines, packaging, transport and inventory space is wasted. For any food and beverage company, there is an obvious operational and environmental cost for food waste.

WEATHERING THE STORM: USING TRACEABILITY TO PROTECT YOUR BRAND IN TIMES OF CRISIS

The media investigation into the medical device industry has prompted governments to pledge stronger regulations to protect patients from the potentially harmful—or even lethal—consequences of receiving substandard medical implants.

Treating the medical device crisis with traceability

On Monday, November 26, 2018, the U.S. Food and Drug Administration announced plans to modernize the way it approves medical devices, finally bringing a process that dates to the 1970s into the 21st century.

8 steps to prepare your pharmacy for medicine authentication and EU FMD

Retail pharmacies, hospital pharmacies and healthcare institutions all have a critical role in ensuring the authenticity of medicines dispensed to patients. It is important that all stakeholders act quickly to ensure they comply with the EU FMD regulations while there is still time to prepare.

optel certa

3 EASY WAYS TO OPTIMISE THE FMD DECOMMISSIONING PROCESS

Article by Diederik de Bruijn, Pharmacist

How can pharmacists ensure that the processes they adopt to comply with the European Union’s Falsified Medicines Directive (EU FMD) are as efficient as possible? We suggest three strategies to optimise efficiency and minimise the impact on day-to-day operations.

TRACEABILITY RECOGNIZED AS KEY TECHNOLOGY TO MEET UNITED NATIONS SUSTAINABLE DEVELOPMENT GOALS

Article by Louis Roy

"Recently, I had the honor of being invited to two major UN world conferences, the World Economic Forum’s Sustainable Development Impact Summit and the UN Global Compact Leaders Summit, which gathered over 4,000 like-minded and important players from various sectors across the globe."

Fishy business: Fighting fish and seafood fraud with digital traceability systems

Have you ever wondered where that fish filet on your plate really came from? Are you absolutely certain that the white tuna or butterfish in your sushi isn’t really escolar? Without clear, legal labeling and end-to-end traceability of the fish and seafood you eat, you may never know.

OPTEL’s Serialization Software to Meet 2019 DSCSA Saleable Returns Requirements

While most everyone knows that November 2018 is the deadline for item-level serialization under
the U.S. Food and Drug Administration’s Drug Supply Chain Security Act (DSCSA), some may not be
aware that the DSCSA saleable-returns verification process becomes effective November 27, 2019.

Managing pharma recalls with Track&Trace solutions

Pharmaceutical product recalls are on the rise in the U.S. and abroad. We explain the 5 main reasons recalls happen and propose an easy and efficient solution.

NEUINTERPRETATION DES KLEINERZEUGER-DATENERZEUGERS

REIMAGINING THE SMALLHOLDER DATA PRODUCER

We need to rethink the way we engage smallholders to avoid dysfunctional and unsustainable ecosystems. We definitively need to reimagine our strategies. So how do we include smallholder producers in this new booming economy and ensure they get their fair share?

Don’t wait: Make sure you can aggregate today so you’re ready for tomorrow

As we pointed out in a previous blog post, the differences between regulatory serialization and track & trace requirements around the world can be tricky for wholesalers and distributors to navigate.

REQUIREMENTS AND CHALLENGES OF AGGREGATION IN THE UNITED STATES

The production of counterfeit and fraudulent products is an extremely lucrative business, especially where medication is concerned. The black market for prescription medication has become a global threat and continues to flood hospitals and pharmacies throughout the world, putting put many patients’ lives at risk.

CMO Compliance with EU FMD: Time Is Almost Up!

If you’re a contract manufacturer in Europe, you know that time is running out to choose a solution provider to meet upcoming compliance deadlines. To cross the compliance line faster, you need to choose a solution provider that is the best possible fit.

GET SMART: FALSIFIED MEDICINES DIRECTIVE FAQS

The February 2019 EU Falsified Medicines Directive (EU FMD) deadline is fast approaching, so it’s crucial that pharma companies and their supply chain partners be well versed on the compliance standards to ensure a smooth implementation process.

FIGHTING FOOD FRAUD WITH TECHNOLOGY

Due to an increasingly globalized food chain and economic incentives to provide products at a lower cost, food fraud has become a major headache for food brands everywhere. Learn how end-to-end traceability can help solve the problem.

DISTILLING THE ALARMING RISE OF COUNTERFEIT BEER, WINE AND SPIRITS

Whether it’s fake wines in Tuscany, substandard vodka in Russia, or phoney whiskey in Rwanda, counterfeit alcohol is alarmingly on the rise. According to the World Health Organization’s Global Status Report on Alcohol and Health, unrecorded alcohol has come to represent approximately 25% of all alcohol consumption worldwide.

FOR CMOS: SERIALIZATION SOFTWARE THAT DELIVERS COMPLIANCE AND REAL BUSINESS VALUE

If you are a contract manufacturing organization (CMO), you are well aware that time is running out to choose a serialization and traceability solution provider to meet upcoming regulatory compliance deadlines. At OPTEL, we understand the complexities CMOs face and can provide the key features you need in an Electronic Product Code Information Services (EPCIS)/data management solution.

Using technology to cork the wine & spirits counterfeiting problem

PricewaterhouseCoopers estimates food fraud is worth $52 billion globally each year. How can you mitigate fraud with the latest traceability technologies? Interview with OPTEL's VP Global Food and Beverage.

HOW END-TO-END TRACEABILITY CAN HELP YOU REACH YOUR SUSTAINABILITY GOALS

According to the United Nations, the world population is projected to jump from 7.2 billion to 9.6 billion by 2050. With all these mouths to feed in just over three decades, the pressure is definitely on the entire food and beverage industry to implement sustainable solutions.

FEATURED STORY

Most of you know OPTEL as a serialization system supplier for the pharmaceutical industry. This, of course, remains a major part of our business, but did you know that OPTEL’s technology and expertise go well beyond packaging lines?

In fact, over the past two years, you may have noticed that we have been expanding our offering as well as our mission. The goal behind this new direction is to ensure longevity and evolution: ours, yours, and the planet’s.

WHOLESALERS AND DISTRIBUTORS: EU FMD COMPLIANCE IS RIGHT AROUND THE CORNER

If you’re reading this post, you are likely aware that pharmaceutical supply chains in European Union member states must comply with the Falsified Medicines Directive (FMD) by 9 February 2019. As a wholesaler/distributor of medicines, do you know your responsibilities under EU FDM?

PRODUCE TRACEABILITY: POST-OUTBREAK LESSONS

If there is one thing we’ve learned in recent months, it’s that the current traceability practices in the produce industry were not effective in tracing the root of the outbreaks. Where do we go from here? How will supply chain digitization and AI play a key role in solving these issues?

HOW TO MITIGATE FOOD FRAUD AND PROTECT YOUR BRAND

We have all heard about food fraud. Examples are all over the news ─ horsemeat scandal, melamine in baby formula, fake honey, impure olive oil, and the list goes on; however, this blog post focuses on things we don't often hear about: tangible solutions and how companies are mitigating food fraud challenges while protecting their brand.

BRAND PROTECTION & ANTI-COUNTERFEITING

To help address this important global and cross-industry issue, developing secure and truly effective new products is key. With this in mind, OPTEL is working with De La Rue to create the most powerful anti-counterfeiting solution on the market.

Mapping the Journey of Palm Oil with Traceability

Grown only in the tropics, oil palm trees produce high-quality oil used in food products, detergents, cosmetics and even biofuels. In developing countries, palm oil is used primarily for cooking. While it is less frequent in the U.S., this type of oil is present in more than half of all packaged products Americans consume.

WE ARE OUR OWN BIGGEST THREAT – Open Letter by Louis Roy

On March 23, 2018, the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES), a group of 550 scientists under the aegis of the UN, published an alarming report. We are now an endangered species and our planet is in critical condition. Biodiversity, the basis of our food, water and air supply, is seriously threatened. At this rate, we will experience our own extinction.

OUR CUSTOMERS REALLY LIKE US

OPTEL customers who use our Verify Brand® serialization software are very pleased its the with platform, process and helpful people who assist with the implementation. But don't take our word for it; see what our customers have to say!

MAKE SURE YOU’RE DOING VALIDATION RIGHT TO REDUCE THE RISK OF SERIALIZATION GOING WRONG

OPTEL offers its costumers a flexible platform with environments for testing, validation and production. Consumers even have full control over their updates! OPTEL also offers documentation support and trading partner connections for the duration of the service agreement. Click to see our solutions and how OPTEL can outperform the competition!

LEVERAGE YOUR SERIALIZATION DATA TO IMPROVE BUSINESS OPERATIONS

Despite the upcoming deadline of the European Falsified Medicines Directive (EUFMD), many companies still haven’t finished the serialization implementation process. A few months ago, at the CPhl WorldWide pharmaceutical conference, our Vice-President, Mr. Harris Kamal, showed the importance of selecting a great serialization vendor and why OPTEL's Verify Brand® Software is an ideal solution. Click to see the video!

7 SUPPLY CHAIN INSIGHTS YOUR SERIALIZATION SOFTWARE SHOULD DELIVER

In 2017, our Lead Solution Architect, Scott Pugh, went to LogiPharma to talk about How to Optimize Your Supply Chain in Order to be Able to Have a Smarter One. With the OPTEL’s just-in-time system, your traceability capacities will help you improve your ROI. Also, we want to show you 7 amazing tips OPTEL's Verify Brand® Software can offer your process and your company. Click to learn more about the conference!

WE DO VALIDATION THE RIGHT WAY, AND OUR CUSTOMERS AND AUDITORS AGREE

At OPTEL, we know the serialization phase is important. It’s the reason why we always guide our customers during this part of the process. It is true to say that OPTEL suggests three testing environments, creates qualification reports, conducts training, etc. Click to see what our costumers say about OPTEL.

VIRTUAL MANUFACTURER PRAISES OPTEL’S BEST-IN-CLASS SUPPORT

OPTEL understands the reality of the pharmaceutical business, which is why we offer services, support and a highly qualified team to help you with your serialization process. Discover why our costumer, Aytu Bioscience, Inc., chose OPTEL's Verify Brand® Software. Read more about the success story!

GET SMART ABOUT TOTAL COST OF OWNERSHIP & HIDDEN COSTS

As we race toward serialization deadlines, one of the questions we frequently get from pharma manufacturers, CMOs, 3PL and repackagers is this: how do we really quantify total cost of ownership (TCO)?