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.
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.
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.
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.
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."
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.
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.
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.
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?
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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?
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?
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.
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.
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.
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.
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!
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!
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!
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!
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.
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!
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)?