July 2019 - rfxcel.com

The digital supply chain is not just about compliance; it’s also about business value and optimization

Published by Tech Panda

Starting with compliance

Many regulatory agencies, like DAVA and FMD, require manufactured prescription drugs to be serialized and uploaded into a national medicines database. India is one of the largest providers of drugs globally. Therefore, it is critical that Indian pharma meet statutory deadlines like the November 26, 2018, DSCSA and the February 9, 2019, FMD. Fail to meet these requirements and Indian pharma economy will likely suffer.

Early adoption often leads to a gain in market share. Furthermore, serialization and traceability can provide companies with the ability to know every distinct entity within their supply chain, what each product is, and its make-up. Serialization paired with innovative technologies, like Internet of Things (IoT) technology, can offer additional value beyond that of traditional track and trace software. With the help of IoT, companies can pinpoint in real-time the exact location of a product, the temperature, the various routes and handoffs, and where the product ultimately ends up. Such on-demand end-to-end visibility has critical high-value implications.

The future with Blockchain, Artificial Intelligence, and Machine Learning

Traceability companies are unlocking the benefits of technologies like blockchain, artificial intelligence (AI), and machine learning (ML) to digitize the supply chain operations.

One of the most exciting innovations in supply chain at the moment is blockchain. Traceability companies, such as rfxcel, are actively working to pilot blockchain efforts. We believe that track and trace systems provide the perfect environment to experiment with blockchain. Because blockchain is a secure immutable technology that operates through a peer-to-peer network, our solutions have established ecosystems to allow only credentialed trading partners to participate in the medicines supply chain. While the data is currently being passed via web services with AS2 or EPCIS, these regulatory ecosystems have demonstrated that there can be a trusted partner environment with clear handoffs. Once regulations are fully implemented, and the trading partner ecosystems are connected and collaborating, blockchain technology will start maturing for the pharmaceutical supply chain.

Digital supply chain is also being affected by artificial intelligence and machine learning.  Track and trace and compliance efforts have led to enormous amounts of data, too much for humans to decipher and make decisions. We’re actively working with our customers to help them implement artificial intelligence to use their data predict issues.  Paired with machine learning, systems will correct issues by making decisions without human intervention. Pharma companies will see faster and fully optimized operations, including demand forecasting, intelligent logistics, course corrections, anticipatory ordering.

Compliance – everything to gain and nothing to lose

We encourage the industry to view compliance as the key to unlocking enumerable supply chain benefits. The future beyond DAVA, DSCSA, and FMD compliance is exciting, but companies must first achieve compliance before they can get to the good stuff.  And selecting the right solution provider is the key.



This article contains a client of an ESPACIO portfolio company.

About the author:

Vikash Pushpraj is the Senior Vice President in charge for Professional Services, Cloud Operations, and Customer Success of rfxcel. Before joining rfxcel in 2017, Vikash spent many years successfully leading departments of product development and customer success at a number of Fortune 500 software companies, such as PTC and Autodesk, where he was responsible for a product portfolio that generated $600+ million annual revenue. Vikash also has entrepreneurial experience from a number of successful start-ups and brings a renewed sense of vigor at rfxcel, often stressing the importance of time management and urgency in providing overall customer success.

About rfxcel:

Founded in 2003, rfxcel is one of the first companies to focus on the safety of the pharmaceutical supply chain and bring advanced track and trace software to manufacturers, repackagers, wholesalers, distributors, and dispensers. rfxcel’s mission is to be the thought leader in traceability technology for Life Science, Food and Beverage and other industries.  rfxcel enables customers to better manage their business today and deliver value tomorrow. For more information, visit 

To learn more about Supply Chain Visibility click here.

To learn more about Regulatory Compliance Software click here.

Contract Packaging: Enhancing Track and Trace in Supply Chain Visibility

Contract packaging is the process of creating and assembling packaging for a product to get it ready for retail sales. A contract packaging organization (CPO) is an extension of a manufacturer, as it is responsible for making product packaging reliable and presentable.

CPOs exist because it is much easier and less costly for manufacturers to outsource this work to a specialized company. By using CPOs, manufacturers avoid significant infrastructure investments and having to expand their teams to do specialized packaging processes themselves.

Overview of the Contract Packaging Process

The scope and complexity of every packaging project depend on the product itself. This is why CPOs work closely with product managers and manufacturers to create packaging that is suitable for both the product and the brand.

Once the companies have consulted and agreed upon processes, the wheels are put in motion. This typically includes six phases:

Phase One: Design

Most CPOs have a design team. This allows them to create original packaging for clients and address any design-related problems with prototypes.

Phase Two: Inventory Management

As products are received (with or without packaging prototypes), each delivery must go through an audit and be properly stored.

Phase Three: Printing Components

In most cases, the products are received with accompanying artwork that must be printed on the packaging components.

Phase Four: Production of Packaging Elements

During this phase, the elements that make up the packaging are created. This can mean producing trays, blister packs, clamshells, and other elements.

Phase Five: Assembly

This is when a product is actually packed. It can be a complex process. Each product requires a specific packaging sequence to ensure quality and condition aren’t compromised. Any accompanying material — stickers, coupons, manuals, etc. — needs to be correctly fitted or affixed.

Phase Six: Storage

The final stage is to store the packed product to await transport to a retailer (or another storage location). Some products may require specific storage conditions, such as temperature and light. This is why some CPOs specialize in certain types of products, pharmaceuticals, for example.

Different Types of Contract Packaging Solutions

Not all CPOs offer the same services. As a manufacturer, it is important to hire a company that can accommodate the exact requirements of your product.

  • Primary packaging: Includes direct contact with the product (e.g., liquid, powder)
  • Secondary packaging: Includes packaging after the primary packaging has been completed
  • Co-packer: Includes a degree of manufacturing and primary and/or secondary packaging
  • Hand assembly: Includes manual assembly of packaging (e.g., gluing, folding, fulfillment) to create point-of-purchase displays, gifts sets, and other such setups.
  • Rigid bottle filler: Fulfillment of bottles and other rigid containers with the product along with capping and shipping preparation

This is an overview of the complex work CPOs do. The goal is always the same: Get the product safely to retail shops in an appealing, high-quality package. CPOs, like manufacturers, need to be able track their products at a unit level, right down to the smallest saleable unit. Doing this will allow for complete supply chain traceability. If you’re looking for a solution to help you trace your contract packaging process, get started with rfxcel today!

The EU Falsified Medicines Directive – for the Pharmaceutical Dispenser



SEP 26, 2018

Please join rfxcel for a webinar that will provide insight into the upcoming serialisation requirements of the EU FMD and how this relates specifically to Dispensers. In this 45 minute presentation, we will discuss:

1. Overview of the key features of the FMD
2. What the FMD means for Dispensers: Who does what and when are they expected to do so
3. What to think about when selecting a FMD solution provider
4. Stand alone FMD solution versus those integrated with pharmacy software – Pros and Cons
5. How installation and roll-out is performed

About our Speaker:

Mark Davison, based out of the UK, is a leading traceability and digital heath expert as well as the published author of “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”. Mark specializes in global health and big data issues such as serialisation, supply chain security, patient safety and government policy. Mark is currently the Senior Operations Director for Europe, at rfxcel, and is looking forward to the opportunity to share his expansive knowledge on this topic.


Serialization Requirements in Russia



MAY 29, 2019

Please join rfxcel for a webinar on 29 May to learn more about the upcoming Serialization Requirements in Russia. During this 45 minute long presentation, we will shed some light into a highly complex set of serialization requirements. All parties involved in the manufacturing of and the distribution of medications in Russia, must comply with these requirements. We will also allow time at the end for a brief Q/A session. The main topics of discussion during this webinar presentation will be:

– An Overview of the Global Serialization Landscape
– A Detailed Explanation of the Serialization Requirements in Russia
– Mandatory Labeling Requirements for 2019 and 2020
– How these Requirements Apply to the Pharmaceutical Industry
– What Do I Need to Do Now in Order to be Compliant by the Deadline?

Please note that we encourage registration for this webinar even if you are unable to attend at the scheduled date/time. All approved attendees will receive a copy of the webinar following the presentation. This webinar is merely for educational purposes and is our informed opinion, not formal regulatory advice. We try to ensure accuracy, but we make no warranty or guarantee. Attendees are advised to confirm their own obligations directly with local regulators as necessary. At this time, rfxcel does have the right to exercise refusal into this webinar presentation.


How Track & Trace Software Can Help You Ship Food Internationally

With the world’s population at 7.7 billion and counting, the food industry needs to make sure it’s doing everything it can to secure its supply chains. On top of all the hard work this requires, food suppliers and shippers are held accountable for the quality and safety of their goods.

The problem is that food can encounter an array of complications on its journey, whether it’s across a state or across the world. It can spoil because of inadequate storage conditions. Packaging can get damaged. Bad actors might try to tamper with it or steal it. The list goes on.

However, with powerful track and trace software monitoring your supply chain, shipping food worldwide becomes much easier and less risky. Let’s look at some of the benefits of using track and trace software when shipping food internationally.

Accurate Supply Chain Data Builds Consumer Trust

Modern consumers are very picky when it comes to food, and rightly so. Most are looking for healthy alternatives such as organic vegetables and grass-fed beef, as well as eco-friendly options from sustainable growers and ethically sourced free-range products.

A transparent supply chain is the best way to ensure your customers that your products are exactly as they’re described on the label. Track and trace software provides just that. This is especially important when you’re trying to break into a new market or competing with big, established brands.

Using track and trace software, a food company that has nothing to hide can show a product’s entire journey — from the farm to packaging plants to warehouses and all the way to their customers’ tables. Customers will trust these products and recommend them to others.

Track & Trace Ensures Maximum Safety

A lot of things can go wrong with a shipment. When we’re talking about food, there’s always the risk that a defective, improperly stored, or expired product might harm consumers.

Most countries have strict government oversight and regulations for food, and the only way to ensure that your inventory is compliant and completely safe is to have the right software.

Track and trace software allows you to guarantee that your freshly harvested products comply with all regulations and remain in their optimal state throughout the shipping process.

With the complete end-to-end traceability offered by rfxcel’s Integrated Monitoring (rIM) solution. you can sleep easy knowing that your supply chain is running smoothly. You can monitor more than a dozen environmental factors, such as temperature, light, and tilt, in real time, ensuring that all the food you ship gets to your customers safely and looking (and tasting) like it should. You can monitor at a top-level — case, pallet, or truck — and track at an item level. rIM also ensures you’ll be compliant with government regulations, no matter where you’re doing business.

Spot Issues Instantly & Solve Them Quickly

Track and trace software empowers you to be proactive about your supply chain management. If there’s a problem, you’ll get an alert. For example, if you identify a problem at a supplier or warehouse, you can fix it before the food gets a chance to reach consumers and damage your brand’s reputation.

When you have a real-time overview of everything from raw materials in different storage facilities to the supply chain as a whole, it’s easy to lock down any defective or compromised goods in your inventory. Recalls and audits become a straightforward affair, and you can contain any problems well before they have a chance to turn into something bigger.

You can also create highly detailed reports about any incidents within minutes and use all the data you’ve gathered to set up fail-safes to avoid similar situations in the future.

In the modern way of doing business, there’s no room for mistakes and poorly managed data. A track and trace software solution offers excellent traceability of food products, ensuring maximum safety and efficiency.

Track and trace with rIM gives you deep, real-time insight into all your processes and the power to deal with any issues as they arise, all of which can help you when shipping food internationally. Get started today with rfxcel!

VRS UPDATE – Understand VRS but Want to Know More? Hear the Latest Updates on the VRS Effort Here



FEB 27, 2019

Join us for Webinar #2 in a 2 part series on the Verification Router Service (VRS). During this 45 minute long presentation, including time for live Q/A, we will discuss the following topics:

1. Insight into the Verification Router Service (VRS)
2. Timeline/Updates on the VRS Program
3. rfxcel’s VRS Pilot Findings
4. What’s Next for VRS – Industry Updates

Please note that this presentation will be recorded and a copy will be sent to all registrants following the webinar’s conclusion.


How Unique Identifiers (Serialization) are Changing the Traceability Game



DEC 6, 2018

Managing global supply chains and validating the origin of ingredients is a major challenge. The consequences for mislabeling, fraud, adulteration or a food safety recall can be devastating to your organization’s reputation and bottom line.

Join rfxcel for a webinar to learn how we can help you track ingredients and raw materials through to finished goods; providing you with a heightened ability to validate your brand claims, mitigate risks, and gain unprecedented insights into your supply chain operations. We will share with you how we can assist with this process by means of unique identifiers (serialization) & a level of prodigious customer engagement opportunities. We will also share with you how this degree of transparency will allow your organization insight into how consumers are responding to your product(s) as well as visibility into valuable data such as freshness and origin.

We hope that you can join us and we encourage you to register via the link below. This event will be recorded and a copy will be sent to all registrants following the presentation. If you have any questions in the meantime, please email us at rfxwebinars@rfxcel.com


Data Integrity in the Pharmaceutical Supply Chain



JUN 20, 2018

Please join rfxcel for a webinar presentation regarding Data Integrity in the Pharmaceutical Supply Chain. During this 45 minute recorded webinar we will cover the areas of:

1 – Why data integrity is only as good as the weakest link
2 – How data errors can occur in validated systems
3 – Why active error checking is needed
4 – What regulators are planning
5 – How you can prepare

This webinar will be hosted by Mark Davison, Senior Operations Director in Europe, at rfxcel. Mark is a leading traceability and digital heath expert as well as the published author of “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs”. Mark specializes in global health and big data issues such as serialization, supply chain security, patient safety and government policy.

Please note that this webinar will be recorded, and a copy of this session will be sent to all attendees.


It’s serialisation – Just not as you know it

Published by Express Pharma

In recent years, India has come to the fore as a major player in the global pharmaceutical market. According to the India Brand Equity Foundation (IBEF), the Indian pharma market is the third largest in the world by volume and 14th largest by value (approximately Rs 1.95 trillion, or $30 billion)i. Today, pharmaceuticals manufactured in India account for approximately 10 per cent of the world’s pharma volume and are exported to more than 200 countriesii, with further growth expected.

While India has taken important first steps in helping to ensure the security of the global pharma supply chain – largely through its leadership in recognising the importance of pharma serialisation and traceability processes – recent international regulatory changes are now having a significant impact on the data, connectivity and technology infrastructure companies must have in place.

With the clocks counting down for pharma companies to not only comply with the EU Falsified Medicines Directive (EU FMD) and US Drug Supply Chain Security Act (US DSCSA) regulations, but also to understand the unwritten rules of supply chain best practice, if Indian pharma firms are to continue to manufacture and export internationally, then they must start taking a hard look at the evolving international serialisation requirements.

Serialisation Law

Serialisation is the process by which products are marked with a standards-based unique identifier— typically a unique number or alphanumeric code—and is the enabling technology for systems and processes to enhance supply chain security.

The regulatory push to secure the pharma supply chain comes as a result of rising drug-related criminal activities and supply chain inefficiencies. Efforts are aimed at addressing drug counterfeits, unauthorised parallel supply chains, improving supply chain visibility, difficulty in tracking returns/ recalls and scarcity of data-driven tools for predicting patient behaviour.

However, serialisation of pharma (i.e., applying the unique identifier to medication packaging) itself provides virtually no benefit to the supply chain. Rather, it is the use of that serialised data in a manner to efficiently realise the goals of the end-to-end system that enhances supply chain security. This complementary use of the serialised data is commonly referred to as ‘traceability’ or ‘track-and-trace.’

India has made great strides toward improved supply chain security through serialisation requirements and the creation of a traceability system, with most manufacturers beginning their serialisation programmes to satisfy the Directorate General of Foreign Trade (DGFT) requirements for export markets, laid out in early 2011.

In 2015, a further draft proposal for domestic drugs was published, but no timelines have been established for the adoption of that set of serialisation, labelling, and reporting regulations.

Latterly, further regulations across the globe have started to take shape.

Passed in 2013, the US DSCSA roadmap for end-to-end traceability is stretched across a period of 10 years, with deliverables outlined for all entities of the supply chain. In the US, lot-level traceability began in January 2015 under the act with package-level serialisation to be completed by November 2018, following an extension granted by the FDA in June 2017. The entire supply chain is expected to be electronically integrated and all nodes of traceability to be established by November 2023.

The European Union (EU) has followed suit with a compliance requirement by enacting Falsified Medicines Directive (FMD). Unit-level serialisation and dispenser authentication has been mandated by February 2019.

India being a major exporter to the US, Europe and other regulated markets, these regulations have a significant impact on Indian pharma manufacturers, and the trend is now clearly visible. The end objective of all the regulations is traceability, where serialisation is acting as the key enabler. Taking a cue from these global proceedings, Indian manufacturers are being urged to review at their serialisation programmes with traceability as a core component of their strategy.

Serialisation in practice

Serialisation and traceability require three key components: an understanding of all products distributed through the supply chain; an understanding of all parties that participate in supply chain; and a mechanism for identifying and ensuring the good standing of all parties that participate in the supply chain.

To achieve this understanding, and then be able to act it, is a significant undertaking. It requires the implementation of processes and software to generate, affix, and capture data related to the unique identifier. It may also require the potential reconfiguring of packaging lines, which in itself takes time to install and validate.

In addition, systems and processes between downstream trading partners, such as wholesalers and pharmacies, must be in place to receive, ship and dispense products. And, particularly in relation to the US market, full traceability requires serialised packages to be aggregated to cases, bundles, pallets, and other logistical units. As its most basic, if the data isn’t in the system, then the product can’t get through the supply chain.

Finally, the systems must be in place for the serialised data to be submitted to the relevant regulators and databases, from DAVA, to the FMD EMVO hub and the FDA in the US. Finding a serialisation partner who is GS1 compliant and registered with the EMVO hub is critical.

Implementing serialisation and traceability

Appreciating the complexity of the regulatory requirements, those organisations embarking on their serialisation and traceability journey should adopt a comprehensive approach to ensure success.

1: Get executive buy-in

Serialisation is a board level issue, with ramifications that could directly affect business performance. It is a business continuity risk that touches every aspect of an organisation. So the first step is to appoint an executive sponsor, ideally with board level oversight, to lead a holistic strategy.

2: Assemble a multi-disciplinary team

Multi-disciplinary engagement is essential. Many organisations don’t understand all their business processes in sufficient detail to overlay serialisation. It’s therefore vital that a multi-disciplinary team (MDT) is convened at the earliest opportunity to map the process flow of the business and establish a roadmap of how serialisation can be applied across multiple organisational boundaries. An MDT should actively engage representatives from manufacturing, supply chain, IT, legal/ regulatory and partner/ contract management.

3: Understand the data implications of FMD

The barcodes required must include 4 lines of data; the unique identifier or Global Trade Item Number (GTIN), serial number, batch number and expiry date. These datasets often live in disparate systems within organisations. The master data – including GTINs – is fixed information that’s commonly stored in an enterprise resource planning (ERP) system.

Having said that, many Indian pharma companies, whilst serialising, currently may not be applying numbers that are internationally compliant. Today’s serialisation and traceability requirements demand that organisations are registered with the global standards authority GS1. As part of the GS1 registration process, organisations are effectively buying the licence to use the intellectual property known as the GS1 identifiers (GTINs) to globally identify your company and products and converse with other companies. around the globe.

Even with the relevant licences and identifiers in place, the master data still requires attention to ensure it’s clean and accurate when uploaded to the repositories. In terms of variable data, the processes required to generate serial numbers, transfer them to production and ensure they’re used appropriately are complex. Managing that immensity of numbers throughout the supply chain lifecycle is hugely important; mistakes can lead to expensive delays, medicines shortages and loss of revenue. Serialisation software is therefore an essential requirement to help you maintain control of all aspects of fixed and variable data.

4: Choose the right software

There are numerous factors to consider when selecting software:


Serialisation should not be divorced from the founding principle of Good Manufacturing Practice (GMP) – quality. GMP guidelines, as well as data integrity advice from regulators such as the UK MHRA, state that users of computer systems must always be in control. However, multi-tenant serialisation solutions (where multiple independent entities share the same instance of a software solution) can sometimes impose software updates without prior dialogue, leaving users out of control. The potential impact on quality is significant. Passive acceptance of change is not an option. Multi-tenant solutions require license-holding companies to ensure that risk assessment processes are in place to monitor and adapt to change. By contrast, the most effective solutions allow users to maintain control of their specific software instance and to dictate the timing, relevance and nature of upgrades.

Data validation

An effective solution will focus on both connectivity and data integrity. Some systems concentrate on enabling a connection and flow of data across and between organisations but are blind to data quality. Companies should never assume that the data entering, or generated within, their systems is clean, tidy and accurate. Internal data checks are essential. The best solutions routinely monitor data to detect human error, inaccuracy and duplication. Smart solution providers validate data flowing through a system – in some cases up to 70 data validation checks on incoming records to ensure its integrity – essentially preventing bad data entering the EU or DAVA hubs.

Network connectivity

It’s not enough to ensure your own business is ready: your partners must be ready too. With outsourcing now common across the industry, it’s important that the software you use connects all parties to a single version of the truth. The most effective solution providers understand the varied nature of the connections you are going to have to make and will commit to connecting your entire partner network as standard. This means more than just having a potential connection – it means working with you and your partners to make sure that data really flows end-to-end across the supply chain.

5: Choose the right partner

Finally, it’s important to find a vendor that can partner with you to design responsive solutions that go beyond technology. As stated above, certification of your vendor by the European Medicines Verification Organization (EMVO) is a pre-requisite if you want to be compliant.

In addition, a partner should be a recognised provider with experience, credibility and evidence that shows it can implement effectively within tight timeframes, including a “follow the sun” implementation model, operating across a number of time zones to ensure that time zone issues don’t become your stumbling block.

A good partner will be committed to your success, keeping you abreast of fluctuating global regulations, and collaborating with you to customise solutions that adapt to changes in your business and the wider market place.


Serialisation and traceability are significant undertakings, but compliance to international regulations and understanding of supply chain best practice are vital to the continued growth and success of the Indian pharma market. Investing in a trusted partner, who understands all the nuances of the international landscape and has the relevant registrations, resources, technology and processes in place, can help you successfully navigate hitherto uncharted territory.

The serialisation standards by FMD will impact all corners of the pharmaceutical industry. Choose a partner wisely to ensure they have the expertise and experience to assist you on your journey.

To learn more about Supply Chain Visibility click here.

To learn more about Regulatory Compliance Software click here.

1. India Department of Pharmaceuticals, Indian Pharmaceutical Industry—A Global Industry, available at: http://pharmaceuticals.gov.in/pharma-industry-promotion. 
2.  Indian Brand Equity Foundation, India Pharmaceutical Industry.

DSCSA and the Verification Router Service – Timelines and Updates



AUG 29, 2018

Please join rfxcel for a webinar that will provide insight into the upcoming DSCSA Regulation(s) for Wholesale Distributors/Dispensers and for details/updates on the Verification Router Service (VRS). During this 1 hour long presentation, we will discuss:

1. FDA/DSCSA Activities for Wholesale Distributors/Dispensers
2. Insight into the Verification Router Service (VRS)
3. Timeline/Updates on the HDA’s VRS Program
4. rfxcel’s VRS Pilot Options and Demonstration