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Packaging perspective correction (with your phone)

Perspective Correction Algorithm for Cell Phone Photography

Image with Midjourney

Cell phone photography has become increasingly popular in industrial and business applications in recent years, with the increase in resolution, accuracy and connectivity. One of the biggest challenges with cell phone photography when applied to Quality Control is correcting the perspective of an image. This is especially important when comparing a master design file with a printed a packaging material. A perspective correction algorithm can be used to address this issue.

The perspective correction algorithm is a software-based solution that adjusts the perspective of an image to make it look as though it was taken from a straight-on angle (thus, correcting the perspective distortion). This is achieved by identifying key points in the image, such as the corners or the edges of a packaging material, and adjusting the image to align these points. The process follows a set of determined steps:

  • Extract key points on both the design and the photo
  • Match those points to identify corredpondance
  • Calculate the required transformation
  • Modify the photography according to the calculated parameters to obtain a corrected image

The use of a perspective correction algorithm is especially important when overlaying a cell phone photo on a packaging design. This can be particularly useful when comparing a master design file (the artwork) with a photography taken with a cellphone of the printed material before it goes into full production. Being able to identify wether the approved master artwork corresponds exactly with the printed material helps reduce (or even eliminate) the risk of printing a packaging material from an un-approved or modified version. This sometimes happens when a stakeholder takes the liberty to modify an artwork for technical reasons and by mistake, something else goes amiss.

Content-based quality checks on printed packaging are crucial to avoid product recalls.

Every Quality Person in the world

There are industrial applications that involve in-line high resolution cameras to compare printed materials with master files. However, they are usually applied for Quality Control on already approved files. Therefore, being able to check before giving the green light for production on a print proof file has tremendous value, specially for highly regulated environments.

If you want to know more about how the perspective correction algorithm works, don’t hesitate to get in touch and we will be happy to chat with you. In the meantime, just to prove this is possible and valuable, you can see how the algorithm works with a really difficult case.

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3 claves para el Rebranding de tu marca

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La organización de la información es fundamental en cualquier proyecto, especialmente en un rebranding de packaging. Una buena gestión de la información asegurará un proceso eficiente, sin errores y con un resultado de calidad. La creación de documentos de apoyo fundamentales para tener éxito en un rebranding son:

  • Procedimiento/s de diseño
  • Template/s
  • Documento/s de calidad

Un template es una herramienta que permite a los diseñadores tener recursos claros y precisos sobre las especificaciones de diseño para una categoría de producto. Este documento deberá incluir detalles como el tamaño, la posición de los elementos y los colores corporativos. Debemos crear tantos templates como tipo de producto vaya afectar al rebranding, si habláramos de la industria farmacéutica serían uno de envase, otro de prospecto y otro para los aluminios por ejemplo.

Un procedimiento detallado es otro documento importante que debe ser creado en la fase inicial del proyecto. Este documento explicará cómo se deben realizar las tareas y los pasos necesarios para lograr un resultado final exitoso. Además, el procedimiento también ayudará a evitar errores y a asegurar que todas las tareas se realicen de manera consistente. De nuevo el orden de dicho documento nos facilitará su uso, no debe ser una descripción del proceso, sino una síntesis de la información fundamental ordenada en capítulos para resolver el “puzzle” o diseño. De nuevo debe hacer tantos procedimientos como tipología de productos.

El documento de calidad es un registro de todas las especificaciones y requisitos necesarios para garantizar un resultado de alta calidad. Este documento debe incluir todos los detalles fundamentales para la aprobación del diseño y será más eficiente en la medida de que seamos capaces de condensar la información en capítulos para centrarnos en una zona o sección del diseño. Un ejemplo reducido de un algunos detalles a considerar en un envase de un medicamento podrían ser:

  • Tipo de archivo (Ai, PDF?)
  • Colores (Pantone +, máximo número de colores)
  • Márgenes
  • Detalles corporativos y logos
  • Braille
  • Revisión de Textos
  • Códigos (EAN, laetus, datamatrix, ….)

Todos estos documentos de apoyo deben generarse en una primera fase, donde se diseñan una muestra de los productos a modificar. Estos modelos servirán de base para el resto de los productos, y garantizarán una continuidad, consistencia u homogeneización en el diseño.

En resumen, la creación de documentos de apoyo es fundamental en un proyecto de rebranding de packaging. Estos documentos asegurarán un proceso eficiente, sin errores y con un resultado de calidad por lo que se debe invertir el tiempo y atención necesaria en su creación además de las pertinentes pruebas de uso para detectar repeticiones innecesarias así como detalles omitidos.

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Puntos clave para tu Guía de Estilo en la industria farmacéutica

Photo by Aron Visuals on Unsplash

El packaging es un aspecto fundamental en el sector farmacéutico, ya que es el elemento de comunicación más directo y visual con el consumidor. Por eso, es importante tener una guía de estilo bien definida para el diseño de los envases de los productos farmacéuticos.

La importancia de tener una guía de estilo específica para un país concreto

La guía de estilo debe ser creada por diseñadores que conozcan el sector y sus normativas, para garantizar que el packaging cumpla con todos las regulaciones en materia de seguridad y salud respecto a un país concreto. Es cierto que muchas veces la guía de estilo es un documento que aplica a nivel europeo y esto puede ser un problema por varias razones. Comparto algunos ejemplos de incoherencias que he encontrado en los 20 años que llevo diseñando packaging farmacéutico, en particular productos genéricos:

  • Documento en inglés con normas difíciles de aplicar cuando tu texto en lugar de “pills” se debe implementar: comprimidos recubiertos con película EFG.
  • Disposición de elementos en contra de la normativa del país, por ejemplo posición del código nacional en una posición que la normativa prohibe explícitamente.
  • Normas de diseño no posibles por normativa cómo diferentes atributos en la fuente del nombre cuando se exige que el nombre debe ser una unidad respecto a tamaño de fuente y formato.
  • Disposición de logos y aspectos visuales corporativos en detrimento de información respecto a contenido u otros elementos más importantes.
  • Disposición de elementos visuales solamente posibles en otros paises o ignorando pautas obligatorias respecto a la normativa vigente.

Si te has enfrentado a una guía de estilo generalmente bastante amplia, creada por marketing o una agencia con experiencia en otros sectores, te habrás encontrado con la frustración que supone intentar seguir una guía que no cumple normativa o que no da alternativas. Una solución es un anexo a dicha guía de diseño con las particularidades de un país en concreto.

El orden es fundamental

Photo by Clayton Robbins on Unsplash

Una buena guía de estilo es una herramienta valiosa que ayuda a los diseñadores y departamento de calidad a crear y revisar respectivamente los materiales para que sean coherentes, eficaces y cumplan con las regulaciones y requisitos necesarios. Además, una guía de estilo bien organizada asegura que el proceso de diseño y revisión sea más eficiente y que los errores sean mínimos.

La organización por tipo de producto es fundamental en la guía de estilo, ya que cada envase requiere un tratamiento específico en cuanto a su diseño y presentación. Una buena guía de estilo debe tener secciones dedicadas a envases blister, envases verticales, aluminios, viales, entre otros. Por ejemplo, un envase tipo blister requiere una tipografía clara y legible, mientras que un envase para viales necesita un diseño más compacto y que aproveche al máximo el espacio disponible.

Es fundamental que la guía esté estructurada de manera clara y sencilla, de modo que sea fácil de seguir y consultar. De esta manera, los diseñadores y departamentos de revisión cómo marketing o calidad pueden acceder a la información relevante de manera ágil y eficiente. Esto evitará errores y re-diseños innecesarios, y permitirá acelerar el proceso.

Actualización con el mercado

Otro detalle a tener en cuenta es la falta de actualización a lo largo del tiempo dado que un documento tan extenso y que supedita tantos detalles no se actualiza anualmente obviamente, pero si debe tener en cuanta los cambios de normativa y ser suficientemente orgánico para poder generar un anexo útil. Un ejemplo relativamente cercano puede ser la serialización. ¿Hace cuánto fue ese proyecto? ¿Se ha actualizado tu guide line al respecto?. Es cierto que dicho proyecto no va afecta a todos los diseños, pero si la etiqueta que debes incluir en tu envase esta sobre un texto no duplicado sabes que tu diseño será rechazado.

Resumiendo, si quieres que el trabajo de tus diseñadores así como departamentos de revisión de materiales implicados sean eficientes tu guía de estilo debe cumplir los siguientes cuatro puntos:

  • Creada desde y para la industria farmacéutica.
  • Ajustarse a la normativa del país de aplicación o un anexo en su defecto.
  • Estar ordenada en secciones o capítulos por tipo de producto.
  • Ser un documento orgánico que sea actualizado con los cambios de dicha industria.
Photo by Glenn Carstens-Peters on Unsplash
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Packaging Reduction: Non Food items

Images: Belinda Ramos, Artist @Twonas.com

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?

  1. 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.
  2. 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.
  3. 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.
  4. 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?

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Two Factor or not two factor … that is the question

Image created with Midjourney

Did you know that there are almost 1,000 attempts to hack account passwords every single second?

That is 1,000 now

… and 1,000 now,

… and 1,000 now.

In today’s world where cyber threats are on the rise, companies must prioritize the protection of their data and systems. Implementing a Two-Factor Authentication model is a sensible way to make sure that your tools, data and information are secure.

So, what is Two-Factor Authentication?

Two-Factor Authentication (2FA) is a security process that requires users to provide two forms of identification to access their accounts. You can see it as an extra layer of security that makes it harder for hackers to gain access to sensitive information such as username and passwords, as well as critical company data.

Why should you use a 2FA process?

Here are a few reasons why it may be important for your company to consider this option:

  1. Enhanced security

    2FA adds an extra level of security to the login process. With it, in order to access an account, a hacker would need to have both the password and the second factor (a one-time code sent by email, phone, or generated by an authentication app). This makes it much harder for a hacker to gain unauthorized access.
  2. Prevents account takeovers

    Account takeovers occur when a hacker gains access to a user’s account and can cause significant damage to the company’s systems, data, and/or its reputation and brand image. With 2FA, even if a hacker obtains a user’s password, they will not be able to access the account without the second factor.
  3. Meets industry standards/ requirements

    This may be one of the reasons why many companies are implementing a 2FA protocol. For industries with very strict requirements (or even regulations) regarding data security, companies may be required to use 2FA to be in compliance.

    By using 2FA, companies can demonstrate their commitment to data security and avoid potential fines and penalties for non-compliance.
  4. Easy to implement

    2FA can be easily implemented for most systems and tools, and many already have built-in 2FA options. In many cases, users simply need to enable 2FA in their account settings, and they’re good to go!
  5. Improves user trust

    By using 2FA, companies can show their customers, users, and partners that they are committed to protecting their sensitive information. This can build trust and improve customer satisfaction, as users will feel more confident that their information is secure.

Are you in charge of making these decisions, or at least, of bringing the discussion around it in your organization? A word of warning for you then: It is possible that some users would be a bit against the implementation of 2FA, as it requires an extra step. Imagine that because some users decide that taking 2 extra seconds to verify a code on their email is too long, and this protocol is not implemented, and this user’s computer gets hacked and access to your data is obtained. Was it worth it? I bet it would not be. As the saying goes… it is always better to be safe, than sorry.

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Mistakes on medical leaflets

The packaging of pharmaceutical products is a crucial aspect of the industry. It serves not only as a protective barrier for the product, but also as a means of communication between the releaser and the consumer. The releaser, a pharmaceutical laboratory, must ensure the existence of an appropriate pharmacovigilance system that allows him to assume his responsibilities and obligations in relation to the pharmaceutical specialties he markets and ensure the adoption of appropriate measures when necessary.

Risks and consequences

One of the most important components of pharmaceutical packaging is the leaflet, also known as the patient information leaflet (PIL), which provides information about the product, including its intended use, side effects, and usage instructions.

To check the content of a leaflet thoroughly is critical, as even a small typo, missing text, or added text can have significant consequences for the patient and the releaser.

Why?

Midjourney image

It is important to avoid errors in the leaflet because they can result in medication errors. For example, if a typo results in the incorrect dosage instructions being printed on the leaflet, the patient may take too much or too little of the medication, which can have serious consequences for their health. Similarly, if important information about side effects is missing or incorrect, the patient may not be fully aware of the risks associated with taking the medication. Believe me, there are side effects which patient and relatives should be fully aware from small possible irritations to a tendency to gambling, side effect that is only revealed after clinical trials for obvious reasons.

Deviation in the leaflet can also result in recalls and legal issues for the releaser. A recall is a costly and time-consuming process, as it requires to retrieve all the affected products from the market and replace them with new, corrected versions. In some cases, the recall may result in significant financial losses, as well as a damaged reputation and loss of trust from consumers.

As a designer and knowing the sensitivity of this situation, the corresponding procedure, quality documents and relevant tools are essential. Just thinking about the lack of an appropriate software 15 years ago makes me dizzy.

How to avoid mistakes

Midjourney image

In order to avoid errors in the leaflet, it is important to have a robust quality control process in place. This may involve multiple rounds of review and testing by different employees within the company, we call it four eyes principle. The process should also include a thorough review of the final product before it is released to the market, in order to catch any last-minute changes or mistakes.

In conclusion, checking the content of a leaflet in the packaging of pharmaceutical products is a crucial step in ensuring patient safety and avoiding costly recalls and damage to brand image. By having a robust quality control process in place, releasers can avoid errors and ensure that the information provided in the leaflet is accurate and up-to-date. Patients can also play a role reporting any discrepancies to their healthcare provider. By working together, the industry and consumers can ensure that the information provided in the leaflet is accurate and that patients receive the best possible care.

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Challenging times for the cosmetics industry

Image generated with Midjourney

The European beauty, personal care, and cosmetics industry is being challenged at the moment, with multiple regulations and changes to earlier ones taking effect during this and coming years.

One major change happened in April 2022, with the amendment to the cosmetics regulation that affected product labelling. This change was made to ensure the safety and well-being of consumers, improve market surveillance and create a level playing field for cosmetics companies within the EU. The new regulation has set several deadlines that companies must meet by 2023.

Ingredients list

The cosmetics regulation requires companies to provide detailed information on the ingredients used in their products. Companies must list the ingredients on the product label in descending order of concentration, and provide a full list of ingredients on their websites or through a consumer hotline. This information must be available by July 2023, and will help consumers make informed decisions about the products they purchase, including any potential allergens or harmful ingredients.

In relation to this, the list of allergenic chemicals that need to appear in the label if found in fragrances or essential oils at levels greater than 0.001% for leave-on products or 0.01% for rinse-off products, was increased to 81.

Warnings

Another major change to the cosmetics regulation is the requirement for companies to provide warning and precautionary statements on their product labels. This includes information on the safe use of the product, such as the recommended usage, and any potential risks associated with the use of the product. Companies were required to provide this information by January already, and it will help consumers make informed decisions about the use of cosmetic products and reduce the risk of adverse reactions.

Non-compliance measures

In addition to the new labelling requirements, the EU has increased its resources for market surveillance to ensure that companies are complying with the new regulations. This includes unannounced inspections, random sampling, and regular monitoring of companies. The EU is expected to take enforcement action against companies that fail to comply.

There is no doubt that the recent amendment to the cosmetics regulation is a significant step forward in ensuring the safety, transparency and sustainability of the cosmetics industry in the EU. However, the changes come hand in hand with other regulations that even if not specifically crafted for it, also affect this sector. Examples of such are the European restriction on microplastics, or the EU Packaging and Packaging Waste directive – which we may address at a later time.

The amount of changes and the need to adhere to new regulations is making it essential for people in the industry to closely monitor all information around these topics and connect with key sources in order to avoid fines, and other penalties due to non compliance. In many cases, this is also leading to re-labelling/re-packaging of certain lines of products for cosmetics manufacturers.

How are you keeping up to date with all these regulations?

Are you struggling to meet deadlines when it comes to re-packaging /relabelling your products?

Do you find it difficult to confirm if your products are compliant?

If that is the case, these links may be interesting for you:

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Artwork Coordination: an often undervalued, complex role

Photo by Matt Bero on Unsplash Photo of a business person with headset on, a backpack, wearing a shirt, crossing a zebra pad juggling some balls
Photo by Matt Bero on Unsplash

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:

  1. 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.
  2. 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.
  3. 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.
  4. Meeting tight deadlines: Coordinators often have to work with very tight deadlines to ensure that products are available for sale in a timely manner.
  5. Collaboration and communication: Effective collaboration and communication between different departments and stakeholders is essential for ensuring the success of a packaging design project.
  6. 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.
  7. 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.

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On-premises vs SaaS

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.

  1. 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.
  2. 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.
  3. 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?

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Is Software Validation outdated?

Image generated with Midjourney

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.