Directions for use: Full implementation of Twona NeXT Artwork Management System is recommended for all stakeholders in your organization.
Dosage
For optimal results, it is recommended that you fully implement Twona NeXT as your Artwork Management System. This means integrating Twona NeXT into all your processes, training all stakeholders in its use, and utilizing its features to streamline and optimize your artwork management processes.
Risks of not using Twona NeXT
Continuing to work in the traditional way can result in sub-optimal processes, prolonged time-to-market, excessive working hours, messy file folders, untraceable processes, non-compliant systems, and a lack of preparedness for external audits. These risks can lead to decreased efficiency, reduced productivity, and increased risk for your organization.
Warnings
Failing to implement a digital Artwork Management System such as Twona NeXT can result in a lack of visibility and control over your artwork management processes, leading to decreased efficiency and increased risk. By fully integrating Twona NeXT into your organization, you can streamline and optimize your processes, improve collaboration, and ensure compliance.
It is important to carefully follow the recommended dosage and to fully integrate Twona NeXT into your organization for optimal results. If you have any questions or concerns about the use of Twona NeXT, please consult with your Artwork Management System specialist.
Once upon a time, there was a team of designers who were in charge of creating the packaging materials for a pharmaceutical company. The process was complicated, since there were many stakeholders: The Clan of the CMOs, the Tribe of the Printheads, The Marketing Lords and Orcs of Qualitiland. They followed the same old routine when it came to creating the artworks: they’d first create the design, then implement the text and finally submit it back to the King of Regulatory for proofreading to make sure everything was perfect.
Created with Midjourney
However, things weren’t always perfect. There was no forever happy ending. The designers often (this is an understatement, for this happened every single day of their miserable lives) found themselves having to redo their work. Not because they’d made mistakes creating the artworks….but because the text contained overlooked ghostly mistakes. They called it: The Doomed Text of Eternal Damnation. They’d always get the artwork back, after someone had spent time checking the text after they’d implemented it on the design, and sometimes they’d even have to start from scratch because the mistakes were so big. It was a huge waste of time and resources, and it was holding up the entire process. They felt desperate.
One day, the great Process Improvement King, saw the tears of the Design team and decided enough was enough. He told them they needed to make a change, so they started thinking about how they could improve their workflow. They realized that if they asked the King of Regulatory to checked the text before they even submitted it to the design team, they could avoid a lot of these mistakes and save a lot of time. So, they decided to move the text proofing from the end of the workflow to the beginning. They decided to stand for themselves, mouse and keyboard in hand, and fight for their freedom.
After a long and gruesome battle, they won. Shortly after, the results were amazing. By checking the text before it was implemented on the design, the team reduced the number of iterations needed to get the design approved. They also reduced the total time spent by the design team, which meant they could get the packaging to market faster and had more capacity to handle more jobs. They felt superpowered.
It was a simple change, but it made a huge difference. No more tears, no more late Friday submissions, no more pain. The team was so happy they’d found a solution to their problem, and they couldn’t believe they hadn’t thought of it sooner. From then on, the Regulatory Kind checked the text before submitting it to the design team, and they never had any more problems with their artworks.
Design approvals from multiple stakeholders (regulatory, marketing, client, printer, CMO) can be a challenging and time-consuming task for artwork managers and design teams. It’s like trying to herd cats – it’s impossible, but you still have to try! In today’s heavy workloads, it’s important to streamline the design approval process and save time, reduce delays and ensure projects are completed on time and with as few rounds as possible. What are the 2 key challenges of getting approval rounds right?
Challenge 1: Managing Multiple (often too many) Feedback Loops
When working with multiple stakeholders, there’s always the risk of conflicting opinions, which can result in endless rounds of revisions and delay the project. Quality might ask to add one end of sentence dot, Regulatory wants to skip it to launch the product, Marketing is changing the color of the flap….again, while the printer realised they attached the wrong dieline. OMG moment. To overcome this, it’s important to establish clear lines of communication and a structured review process. This includes setting up regular check-ins, clear expectations and deadlines, and establishing a centralized system for feedback and revisions.
Challenge 2: Balancing Speed and Quality
Another key challenge in managing design approvals is balancing speed and quality. In order to ensure that projects are completed on time, it’s often necessary to move quickly through the design approval process. However, this can result in missed details, oversights, or incorrect approvals. On the other hand, taking too much time to review and approve can be costly or simply unacceptable. To balance speed and quality, it’s important to set realistic deadlines, involve the right people at the right time, and establish a clear and consistent review process.
Bonus Quiz: Serial or Parallel Approvals?
One key component of a proper approval process is the establishment of approval model. This is in many oranizations overlooked and underrated. Let me explain.
The Serial Approval Process
Image with Midjourney
When multiple stakeholders are required to provide feedback and approval, it is common practice to request such approval one stakeholder at a time. The argument that we typically hear is that this allows the design team to fix errors early on before the “important” stakeholders take a look. Every time we face this, it hurts. Intermediate and uncompleted feedback rounds only cause MORE WORK, not less. They also increase the risk of introducing unwanted mistakes.
The Parallel Approval Process
An alternative approach is to request feedback and approval to all stakeholders at the same time, and wait for all responses before issuing a new version. This comes with its own challenges is hardly suited for a traditional email/paper based model.
Golden Tip: Implement an Automated Approval Workflow
To improve and simplify the design approval process, it’s recommended to implement an automated approval workflow. Automated workflows can help streamline the review and approval process, reducing the time it takes to complete designs and minimizing the risk of missed details or oversights. With an automated system, all feedback and revisions are stored in one central location, allowing teams to track the status of each design in real-time. This suits the Parallel Approval Process really neatly and helps to keep the process organized, reduces the risk of conflicting feedback, and ensures everyone is on the same page. It’s like having a GPS for your design approvals – you’ll always know where you’re going and how to get there!
Managing approvals can be a complex and time-consuming process. But, with the right approach, it can be a straightforward and efficient process. By establishing clear lines of communication, balancing speed and quality, and implementing an automated approval workflow, organizations can streamline the design approval process, save time and ensure projects are completed on time and with a few iterations as possible. And, most importantly, they can have a little more peace of mind and a little less stress.
Electrical goods often come with warranties and usage instructions in multiple languages. You know what I’m talking about, the multiple booklets of instructions in 10 different languages or the warranty document to complete and return by post! (remember postage stamps anyone?!), that often fall straight into the recycling bin.
But, there are valid and important reasons for having these. One, being the safety of the consumer and their new product, or information on how to put your new piece of furniture together; but also, one SKU with as many languages included as possible, means a reduction in the overall number of SKUs in production. The more languages you can include, the more countries you can sell that same product in.
So, how do you go about making these important and (sometimes) required pieces of information available while considering packaging reduction and carbon footprint for example? How to squeeze 10 languages on less paper? Do we really need to print out 5 different warranty cards?
A picture is worth 1000 words: Pictures are a universal language and can help convey information without the need for words. This is particularly useful for showing how to use a product or for highlighting specific parts of the product. For example, IKEA provides assembly instructions for their furniture with clear and concise illustrations and no words.
Words: Words are necessary for more detailed instructions and for legal information such as warranties and safety warnings. They also allow for specific language nuances and cultural references that may not be conveyed through pictures alone. Samsung provides detailed instructions in multiple languages for their products, including safety warnings, to ensure that customers fully understand the products they purchase.
Pictures: Using pictures can make the information easier to understand and remember, especially for customers who are not fluent in the language in which the instructions are written. It also saves space, making it easier to include multiple languages in the single document. Apple Inc. uses pictures and diagrams to explain the functions of their products in multiple languages, making the same information accessible to a wide range of customers.
Environmental Impact: Printing documents in multiple languages can have a significant environmental impact, particularly if they are rarely read and often thrown away. Consider providing instructions and warranties in electronic format (online) where possible, to reduce waste. This aligns with companies’ efforts to reduce their carbon footprint and meet overall packaging reduction targets. For instance, Tesla provides electronic versions of their warranties and usage instructions, reducing the amount of paper waste generated by their products.
In conclusion, handling multiple languages in FMCG warranties and usage instructions requires careful consideration of the most effective way to convey information. A combination of pictures and words can be an effective solution, while also reducing the environmental impact of printing (less paper required) or by providing electronic versions where possible. This supports companies’ efforts to reduce their carbon footprint and meet overall packaging reduction targets.
What are you doing to reduce the amount of packaging and unread booklets in your product?
Working in the pharmaceutical industry, the creation of packaging designs can be a challenging and complex process, especially when dealing with multiple Contract Manufacturing Organizations (CMOs) and Printing companies. There are many factors that can impact the design, including regulatory requirements, branding, marketing, and of course, technical considerations. One of the biggest challenges that packaging designers face when working with multiple printing stakeholders (weather it is a CMO or a printer directly) is the varying technical requirements. Different companies have different machinery and different Standard Operating Procedures (SOPs) (sometimes they don’t even have SOPs).
Oh man…this is hard.
The first challenge related to working with multiple printers is the differences in print and packing capabilities. Each printer may have different printing processes and equipment that they use. For example, one printer may use a rotogravure printing process while another may use flexographic printing. This can result in differences in color accuracy, registration, and overall quality of the final print. Additionally, some printers may not be able to accommodate certain design elements, such as holographic foils or raised printing, which can impact the design and the overall look of the packaging. Additionally, and more specifically for the packaging industry, the printed materials are going to be the input of a packing machine which is going to fold, fill, glue and whatnot in an automated machine. This process is critical since failure can have a high cost impact. Most “reasonable” printing companies and CMOs provide technical specifications to their design agencies (or their clients) so the design materials can be created to specs.
The second challenge is the complex technical documentation that designers must understand in order to create compliant designs. Technical documentation often includes specifications on dielines, varnish free areas, margins, folding lines, visual marks used for automated packing and many more. Understanding these guidelines and ensuring that the design meets them can be a time-consuming and confusing process, particularly for designers who are not familiar with the specific requirements of each printer and considering some of these technical specification documents can be 40 page long. If you are dealing with 10 suppliers, times 40 is a 400 page documentation. That is not easy to manage. This can result in mistakes and miscommunications between the design team and the printer, which can ultimately impact the time to market.
What can we do to fix this?
There are ways to improve the process when technical specification documentation is complex and there are many different suppliers:
Write and maintain proper design manuals specifically for each printer/CMO. This will help ensure that the design team has all of the information they need to create designs that are compatible with each printer’s technical requirements. This can also help avoid misunderstandings and miscommunications between the design team and the printer. Additionally, it will be required should you have to face a customer audit.
Perform training of the design team on all technical requirements. This will help ensure that the design team is aware of the specific requirements of each printer and can create designs that are compatible with those requirements. Furthermore, it will help designers find and interpret information faster and accurately.
Allow a direct line of communication with the printer instead of via the client. A direct line of communication can help avoid misunderstandings and miscommunications that may occur when the design team is communicating through the client. Let the technical people speak to technical people directly, otherwise you will face the broken phone syndrome.
The creation of packaging designs can be challenging, especially when working with multiple CMOs and printers. The varying technical requirements of each printer and the long and complex technical documentation can be a pain in the arse to deal with and a high risk factor. But don’t despair, by following these three tips – writing and maintaining proper design manuals, performing training on technical requirements, and allowing a direct line of communication with the printer – designers can improve the process and ensure that the final product meets all of the necessary requirements.
Design briefs are essential for creative projects as they help set clear expectations and define the scope of work. However, working with a design brief that has missing (or useless) information such as low-quality images can be a significant challenge. Below you will find the key challenges faced when working with an incomplete design brief and obtain tips on how to create a clear and comprehensive brief.
You must read this if you are a customer
Every designer in the world
The classical challenges
One of the major challenges of working with a design brief that has missing information is the lack of clear guidelines. This often leads to confusion and misinterpretation, resulting in a final product that does not meet the client’s expectations. For example, if the brief does not include all the reference files or text documents, the designer may struggle to understand the client’s request and produce an artwork that is not in line with their requirements.
Another common mistake is the use of low-quality (or low-resolution) images. When the final design needs to be printed, such as packaging materials for like…..everything that is sold, the images provided to the design team need to have sufficient resolution for the required printing size and method (SPOT and Digital Printing can be different). This not only affects the quality of the final product but also the reputation of the designer and the company they work for. Although, in all likelihood, your designer will probably have to reject the job and ask for better images.
5 things you need to do as a customer
It is of the outmost importance to create a clear and comprehensive design brief that includes all relevant information. Here are five tips to help make the brief clear:
Include clear brief information: The brief should include a clear and concise description of the project’s goals, technical specifications and in general the desired outcome. This will help the designer understand the client’s vision and ensure that they are on the same page. Do not make it more difficult that it needs to be….more is not always better.
Add up-to-scale dielines: Dielines are essential for product design, as they provide a template for the designer to follow when creating the final product. This is particularly critical for packaging materials since it will most likely be the input of a packaging machine when mistakes can be very costly. By including up-to-scale, clean and usable dielines in the brief, the designer can ensure that the final product will meet the client’s technical specifications. If you think a blurry scan of a dieline is good enough…..think again.
Include all text documents: The brief should include all text documents that are relevant to the project, such as product descriptions, marketing materials, regulatory texts, and any other content that will be used in the final product. The designers cannot read your mind, they cannot possibly know all the details of the regulatory bodies of the many countries where you are releasing and have no insight on your company’s strategies. Don’t make it difficult, make it nice. If a text needs to be included, please add a readable document that can be copy-pasted (designers do not type).
Add clear and precise annotations: Sometimes the best way to convey an idea is by annotating an existing document indicating any specific requirements or requests that the client has. Be like water, be clear.
Include all relevant references of essential information: The brief should include references to any essential information that the client feels is important, such as brand guidelines or examples of similar products. If it takes time to find those documents, better do it before hand.
Working with an incomplete design brief can be a significant challenge for designers, but with the right tools and tips, it can be overcome. Remember, too much information is just as bad as too little information, so be sure to strike the right balance and keep the brief concise, yet comprehensive. And always remember, a good design brief is like a GPS – it helps you reach your destination with ease!
The use of barcodes has become ubiquitous in the pharmaceutical industry, providing a crucial means of identification and tracking for products in the supply chain. Accurate creation of barcodes is essential to ensure reliable digital reading and to prevent failures that can cause significant disruptions and potentially pose risks to patients, not to mention the costly and feared product recall. In this article, we will explore the importance of creating barcodes accurately and explain why the size of the barcode and the color used in the design are crucial factors to consider. We will also provide two tips to help ensure that barcodes are created correctly for packaging design.
The risks
Poorly printed or sized barcodes can cause digital readers to fail, leading to incorrect identification of products, misdirected deliveries, and even recalls. This does not only pose a danger for the patient but also a significant risk for the brand in terms of reputation and costs.
The size matters
One of the key factors to consider when creating barcodes is the size of the code. The size of the barcode needs to be large enough to be easily read by digital readers, but also small enough to fit on the limited space available on the packaging. The size of the barcode must also be consistent across all packaging to ensure reliable digital reading and to prevent confusion. However, the most important aspect of barcode sizing is following the regulated standards for the selected barcode. Some barcode types allow for more flexibility in terms for size and color while others (like the Pharmacode) are very strict in their technical specifications.
Pharmaceutical Binary Code – The Pharmacode
The pharmaceutical binary code, commonly known as the pharmacode, was first introduced in the 1970s as a means of providing a fast and efficient way to identify and track products in the supply chain. The barcode system was originally based on the Universal Product Code (UPC) developed by the grocery industry. The pharmaceutical barcode, also known as the GS1 barcode, was developed to meet the specific requirements of the pharmaceutical industry and is based on international standards established by the Global Standards One (GS1) organization. The technical specifications of the pharmaceutical barcode include a specific number of digits, with the first three digits identifying the company that manufactured the product, the next two digits identifying the product, and the last digit used as a check digit for error detection. The barcode is also required to meet certain size and printing quality standards to ensure reliable digital reading.
You should NEVER resize the width of a pharmacode.
Rafael Cruz, Studio Manager
Color also matters
Midjourney image
The color used to create the barcode is also an important factor to consider. Barcodes must be printed in high contrast colors to ensure that they are easily readable by digital readers. The color of the background and the barcode must be carefully chosen to ensure that the barcode is clearly visible and easily distinguishable from the background. The use of low contrast colors, such as light blue on white, can make barcodes difficult to read and can cause digital readers to fail.
2 Tips to help you out
To ensure that barcodes are created accurately, there are two important tips to keep in mind. Firstly, it is crucial to use high-quality printing materials and equipment to create the barcodes. This will ensure that the barcodes are clearly visible and easily readable, and will help prevent digital reading failures. Secondly, it is important to regularly test the barcodes to ensure that they are accurately readable by digital readers. This can be done by using a barcode scanner to test the barcodes and to confirm that they are being accurately read.
In summary, to ensure accurate barcode creation for pharmaceutical packaging design, it’s crucial to:
Consider the size of the barcode to ensure it is easily readable by digital readers and fits the packaging space
Choose high-contrast colors for printing to improve barcode visibility and readability
Use high-quality printing materials and equipment
Regularly test barcodes for accurate digital reading with a barcode scanner
The role of an artwork coordinator in industries such as food, pharmaceutical or retail is crucial for ensuring that the packaging design of products is consistent, accurate, and meets all legal and regulatory requirements. However, this position does not always get the appreciation it deserves.
Being an artwork coordinator for the packaging design of products comes with its own set of difficulties and challenges, which can range from managing a large volume of designs, to ensuring the accuracy of information and meeting tight deadlines, amongst others:
Managing a large volume of designs: Artwork coordinators are responsible for simultaneously managing a large number of designs, both for large product launches and small packaging changes, which can be a time-consuming and complex process.
Maintaining design consistency: Maintaining consistency in design across multiple products and packaging, as well as keeping up to date with customer input and market inspiration (not for Pharma products, where all is more regulated) is crucial for creating a strong brand identity.
Accuracy of information: The accuracy of information on packaging is crucial for ensuring product safety and compliance with legal and regulatory requirements. This is specially critical in the FMCG and pharmaceutical industries, where errors can lead to severe consequences on the consumer side. Products that are sold across multiple countries, with multi-lingual labels, represent an extra complexity on this front, to make sure that all information is accurate and meets the local standards.
Meeting tight deadlines: Coordinators often have to work with very tight deadlines to ensure that products are available for sale in a timely manner.
Collaboration and communication: Effective collaboration and communication between different departments and stakeholders is essential for ensuring the success of a packaging design project.
Approval management: this communication and collaboration amongst departments and external parties such as external clients, regulatory bodies, or printers, takes an extra step when it comes to managing the approvals on the artworks. Dealing with both internal and external feedback rounds adds an extra layer of risk in making sure that the correct files are used when it comes to creating the final product that goes in the shelves.
Control of document versions and files in general: don’t you hate it when you receive a final version and then it turns out it is no the final one, amendments are made and you lose track of which file is the one that should be used? With so many projects ongoing and multiple approvals needed, it is one artwork’s coordinator nightmare to make sure the files are correctly stored and identified.
These challenges show how important and complex the role of artwork coordinator can be. Luckily, nowadays, there are tools that can assist an artwork coordinator in their daily tasks to make them more successful and efficient.
An artwork management system (AMS) can help automate and streamline the design process, through custom workflows that will take some of the repetitive tasks out of their plate, and giving visibility to other stakeholders when they need to provide input or approve. Such technology would also make sure that designs used are the correct ones, by providing a central repository for storing and sharing artworks, keeping version control on all files. Through an audit trail on changes, it becomes much more simple to track where a design is at any given time, and who may have performed a change, taking action from there.
Artwork Management System – Twona
Reaching deadlines becomes easier, as the approval process can be automated and they only need to make sure to check feedback when completed. Because the tool would provide real-time updates on the status of designs, they can focus on more valuable activities other than chasing and reminding people. As a central platform for sharing designs and communicating with stakeholders, and AMS would improve collaboration and communication, as everyone is involved and has visibility over the process. Furthermore, additional tools such as artwork comparison/proofing systems can help coordinators verify that the information on packaging is accurate and up-to-date, reducing the risk of errors and mistakes.
The role definition does not need to change. Its beauty is that it interlocks so many areas of the packaging design process. However, it can be more appreciated when the right technology is used to support their multiple tasks, as it will help professionalize and standardize the artwork coordinator function.
Even though the corporate solutions landscape has rapidly evolved over the last decade, the decision between an on-premises software installation and a SaaS cloud solution is a common one that many organizations face. There are several key differences between the two that impact cost, functionality, and security.
Cost: On-premises software requires a significant upfront investment in hardware, maintenance, and upgrades. It also requires the in-house expertise in the form of developers, engineers, infrastructure and security experts. In contrast, a SaaS solution is generally sold as a subscription service and eliminates the need for a large upfront investment. This means that the cost of a SaaS solution is more predictable and often more manageable.
Functionality: On-premises software offers more customization options, but it also requires more expertise to set up and manage. Development and installation takes a significant amount of time as the complexity of the required functions increases, taking several months to years to setup a system. A SaaS solution, on the other hand, is managed by the vendor. It typically offers less customization but is easier to set up and use. If the SaaS solution offers a powerful API, customization can be further extended. This can lead to a more streamlined and efficient process with a significantly lower go-live time.
Security: On-premises software is often perceived as more secure because the data is stored on the organization’s own servers. However it also requires more resources and expertise to manage and protect. A SaaS solution is managed by the vendor and typically offers a higher level of security than an on-premises solution, specially when large scale, well know infrastructure providers are used, such as Amazon. It also involves more trust in the vendor and their security practices, which is typically solved with Information Security audits.
In conclusion, when deciding between an on-premises software installation and a SaaS cloud solution, it’s important to consider the cost, functionality, and security implications of each option. While on-premises software offers more customization options, it also requires more resources and expertise to set up and manage. SaaS solutions are easier to use and offer more predictable costs, but they also involve more trust in the vendor and their security practices. Ultimately, the right solution will depend on the specific needs and resources of each organization, but let’s be honest. Who in its right mind would in 2023 decide to purchase an on-premises solution when there are SaaS alternatives on the market?
Software validation is the process of ensuring that software systems meet the requirements set forth by regulatory bodies, such as the FDA in the United States. This is particularly important in highly regulated industries, such as the pharmaceutical industry, where software systems are used to manage and analyze critical data that is used to support the development and manufacture of drugs.
The origin of software validation can be traced back to the early days of computer technology in the pharmaceutical industry. In the 1970s, the FDA began to recognize the importance of software validation as a means of ensuring the accuracy and reliability of data generated by computer systems. This led to the development of guidelines and regulations for software validation, specifically in the pharmaceutical industry, such as the FDA’s “Guideline on General Principles of Software Validation” in 2002.
One key document that is created during the software validation process is the Master Validation Plan (MVP). The MVP is a comprehensive document that outlines the overall strategy and approach for validating the software. It includes details such as the scope of the validation, the validation team, and the schedule for validation activities. It is the first and foremost piece to documentation that needs to be created.
Following the MVP, you need to build three key documents: OQ, IQ and PQ.
Operational Qualification(OQ) and Installation Qualification(IQ) are used to ensure that the software system is installed and configured properly, and that it functions as intended in its intended environment.
Performance Qualification (PQ) is a process of testing software systems in order to verify that it performs as intended, and that it meets the acceptance criteria defined in the Qualification Protocol (QP).
As the technology and software development methodologies have evolved since the 70s, the need to adapt the validation model for modern SaaS cloud-based solutions has become increasingly important. With the advent of cloud computing, software systems are no longer installed and run on a single machine, but rather they are accessed through the internet from various devices and locations. This is the so called “single tenant system”, which is a radically different paradigm from the early on-site installations. This has led to the development of new guidelines and regulations for validating cloud-based software systems, such as the FDA’s “Guidance for Industry: Cloud Computing and Mobile Medical Applications” in 2013, although one might argue that those models are still outdated given the speed of the advancement of technology and cloud services.
In conclusion, software validation is a critical process in ensuring the accuracy and reliability of data generated by computer systems in highly regulated environments. However, application of outdated validation methods will only led to frustration and failure.
If you are about to embark on a validation process for a SaaS solution but your QA team has only experience on traditional on-site installations, do not rush. Take your time, read the available literature, get familiar with the tools and infrastructure used by your chosen vendor and if necessary, ask for additional budget to ensure the validation is not only successful, but more importantly, relevant.
