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Asking vs SOPing.

In today’s fast-paced business world, every second counts, and no one wants to waste time on repetitive tasks. One area where this is especially true is in the supply chain of packaging design processes where not only time matters but reducing risk is a key factor of the process. Frequently, supply chain teams are asked to supply information that is mostly static and unchanging, yet the requests for this information continue to pour in. For every artwork material surely comes an email requesting the same information. In these cases, identifying repetitive tasks and documenting the necessary information can help save time across the supply chain while reducing unnecessary risks related to information processing.

Let’s consider the following example: An artwork coordinator requests information from the supply chain team regarding the technical specifications of serialisation printing. The details provided by the supply chain always relate to the market where the product is going to be released (different market, different rules) and change only every one or two years when the regulatory bodies change the laws. The request for information is done for every product, and therefore the response from the supply chain is almost always the same. Furthermore, supply chain is the only team up to date on when the regulations change.

In this situation, creating a set of technical specifications in the form of a Standard Operating Procedure (SOP) can help streamline the process. The SOP would describe the serialization requirements per market (what information can be printed where and under which technical specifications), and the supply chain team would become the owners of these documents. By creating and documenting these technical specifications, the supply chain team can prevent the information from being requested for every product, thereby saving a tremendous amount of time while reducing the risk of misinformation.

The benefits of creating SOPs and technical documents go beyond time-saving. By documenting and standardizing information, it becomes easier to communicate and collaborate with team members and stakeholders. This standardization can also reduce errors and improve the quality of the work.

Furthermore, the benefits of documenting information go beyond the immediate supply chain team. If the information is needed by other teams, such as quality assurange or regulatory affairs, having a documented SOP can ensure that everyone is on the same page and using the correct information. This can help prevent delays and ensure that all aspects of the product development process are aligned.

In conclusion, identifying repetitive tasks and documenting necessary information can help save time across the entire supply chain of packaging design. The example of creating an SOP for serialization requirements illustrates how this process can be applied in practice on any company that markets products across different countries. By creating and maintaining such documents, teams can save time, reduce the risk of misinformation, and improve the overall quality of their work.

Do you email or do you SOP?

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Be like water….

Image with Midjourney

When it comes to corporate packaging design, transparency is key. We always insist on this aspect, specially when on-boarding new teams that are used to a more traditional approach where compartmentalisation of information is common practice.

A packaging design workflow involves multiple stakeholders, including internal teams such as marketing, product development, and design, as well as external partners such as packaging manufacturers, suppliers, and distributors. This complex network of stakeholders makes it essential to have a clear and centralised system of information sharing to prevent errors and reduce risk.

Compartmentalisation vs Transparency

Compartmentalisation is the approach of separating information into individual units or silos, which can only be accessed by certain individuals or groups. This approach can have some benefits, such as providing increased security for sensitive information or enabling clear lines of authority and responsibility. However, there are also significant risks associated with compartmentalisation that can hinder the success of a business or organisation.

One of the biggest risks of a compartmentalised approach is that it can create barriers to effective communication and collaboration. So basically some individuals might not know at one given time what is going on because information is hidden from them. This can lead to a lack of coordination, missed opportunities, and duplicated effort, which can ultimately hinder business growth and success.

On the other side of the spectrum, transparent processes can have many benefits. When stakeholders have access to the same information and there is clarity about what is going on at any time, it can help to identify and mitigate risks early on, before they become significant problems.

Transparency can also lead to greater accountability and trust.

Transparency how?

Transparency for packaging design can be achieved through the use of a centralized AMS tool, such Twona NeXT. It allows all stakeholders to have access to project-related information and updates in real-time, reducing the need for manual updates and reducing the risk of miscommunications.

In addition, transparency can also ensure the final product meets all necessary requirements and standards such as compliance with legal and regulatory requirements.

But how far do we go?

The line between transparency and compartmentalisation can however be difficult to spot. Too much of either and the process will suffer or the risk will be too high.

A good rule to thumb for packaging design processes within pharmaceutical teams follows these key aspects:

  1. High visibility – Being able to understand the status of a project within a complex workflow creates trust, clarity and a sense of belonging by all relevant stakeholders. Keep it open, let all relevant parties see what is happening. Limiting visibility is only advisable when dealing with competing external stakeholders such as multiple design agencies.
  2. Silo the actions – For compliance requirements, it might be needed to limit what each stakeholders can do. This is ensure everyone can fulfil their own actions while reducing the risk of mistakes. For instance, the Design team should be the only one capable of uploading new versions while approvals can only be granted by the Regulatory team.
  3. Train everyone on the entire process – A key component of digitising a process is the training that each stakeholder needs to be part of. For larger teams, it might be wise to split the teams to focus on their part of the process. However, the entire process should be shown to all stakeholders to ensure there is clarity and a complete understanding of what is going on at every moment.
  4. Don’t give access to external stakeholders – When collaborating with external teams such as suppliers, printers and others, it is a good practice to establish a collaboration model that is based on an on-demand basis. This means only when the core team requests something from the external members, the information can be provided or consumed, keeping access to the larger process blocked at all times. This approach reduces risks and simplifies the actions that external stakeholders need to take on your process.

In summary, defining the level of access (both views and actions) when digitising your artwork process should be considered as one of the most relevant task before you get started. Think through it, check with all stakeholders, determine which level of transparency fits your team and remember that silos are the enemy of collaboration.

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5 key components of a VMP for SaaS

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Artwork management in the pharmaceutical industry is a critical process that requires accuracy and precision to ensure compliance with regulatory requirements and avoid errors in the packaging design that make it to the market and risk a product recall. The artwork management process is sometimes underestimated as it pertains to a non-core activity for brands and manufacturers of medicines and medical devices. However, it can be a critical aspect when facing an audit and even more when such audit is triggered by a product recall.

Multi-tenant SaaS solutions are becoming more popular with pharmaceutical companies, despite the traditional on-site installations, as they offer lower pricing points and less on-boarding hassle (lower financial costs and faster implementation). One key component that is still not fully understood is the fact that validation of on-site custom made solutions differs significantly from the validation approach required for multi-tenant SaaS applications.

The first key component is the Validation Master Plan (VMP) which outlines the validation process. Here we will discuss five key components that must be included in a VMP document for the validation of a multi-tenant SaaS Artwork Management System.

  1. Scope and Objectives – This section needs to clearly define the scope and objectives of the validation process. Let’s dive in. The scope should outline the functionalities of the multi-tenant SaaS solution that will be validated, including any third-party integrations. It is important to define the scope with care and discuss which components need to be included. One aspect that is often overlooked when validation a SaaS application is that in many cases, there will be external services (typically micro services) and infrastructure. These, as long as they only play a servicing role, can be left out of the scope since they are controlled by a third party. The objectives should detail the specific outcomes that the validation process aims to achieve, such as ensuring compliance with regulatory requirements or minimizing the risk of errors or data loss.
  2. Validation Strategy and Acceptance Criteria – The validation strategy should specify the validation approach, including the type of validation to be performed, such as installation qualification, operational qualification, and performance qualification. It is a good idea to include specifically which aspects of the solution will be relevant for the validation. The acceptance criteria should detail the testing methodology, including the type of testing to be performed, such as functional testing, user acceptance testing, and performance testing.
  3. Roles and Responsibilities – This section should clearly outline the roles of the validation team, project manager, system administrator, and any other key stakeholders involved in the validation process. It should also detail the responsibilities of each team member, including their participation in the validation activities and their expected deliverables.
  4. Testing Documentation – The documentation section should detail the testing documentation that will be used and delivered during the validation process. This section should include a list of all required testing documents, including test plans, test scripts, and test cases. It can also outline the testing schedule and the expected timeline for completing each testing activity.
  5. Change Control – The final component of a VMP document should detail the procedures for making changes to the multi-tenant SaaS solution after the validation process is complete. It should include a list of change control forms (or other methods for documenting the required changes), detailing the requirements for documenting changes, and the process for reviewing and approving changes.

The VMP document is an essential tool that will guide you through the validation process.There is however not a single way to create it. Depending on your scope and criteria, the contents of the document can change dramatically. One critical aspect is choosing carefully which components of the application you are going to validate. For applications that rely on external infrastructure or services, specially when managed by third parties, it might prove difficult to get all the components required to validate those services. Our advice is to focus on your application and ensure that all third party infrastrucure and services are only services and do not represent a core data processing unit of your set of features.

If you get the VMP right, the rest of the validation will be much more approachable than having to come back to the VMP to make changes. Spend your time wisely, get the VMP right and your validation will be a breeze.

Want to know more key differences between a traditional VMP and a VMP for a SaaS solution, let us know!

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AMS Twona NeXT 200mg digital pills

Image with Midjourney

Twona NeXT – Artwork Management System

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.

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The Tale of Doomed Design Team

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.

A forever happy ending after all.

The end.

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Oh god….another feedback round.

Image created with Midjourney

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.

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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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The nightmare of technical specs

Image created with Midjourney

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:

  1. 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.
  2. 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.
  3. 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.

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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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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.