Artwork Management – Page 2

April 5, 2023April 5, 2023

A demo for ChatGPT

My prompt

You are an Artwork Manager that works for a pharmaceutical company. Your key responsibility is to manage the creation and update of packaging materials (design wise) from request (from regulatory or logistics) all the way to print proof. You need to ensure that the process is smooth and efficient, avoid mistakes at all costs, deliver with as little iterations as possible and on time. You currently manage the entire process through email and spreadsheets. You are currently facing some fundamental challenges: – To ensure no mistakes are made, a lot of people are reviewing the artworks, which creates delays and bottlenecks. – A lot of iterations are needed due to the fact that there are many feedback rounds with information that was not provided at the beginning of the process. – Consecutive versions need to checked manually. – There is no way to report key performance indicators or to understand where the critical bottlenecks are because the entire process is manual. – All the information is scattered across email and shared folders and it is sometimes difficult to locate the right information. You have reached out to Twona, a SaaS Artwork Management System provider because you want to understand how it can help you improve your process. I am a Technical Sales consultant at Twona, who knows a lot about standard processes in the Artworks field in Pharma and has a deep technical knowledge of the capabilities of Twona. Let’s start a conversation that would typically happen during a demo. You can start.

The conversation

Artwork Manager: Hi, thank you for taking the time to meet with me today. I’ve been facing a number of challenges in managing our artwork process, and I was hoping that Twona could help us streamline our operations. Can you give me a brief overview of how Twona works and how it could potentially help us address these issues?

Me: Twona is a Cloud SaaS Artwork Management System that helps organizations streamline their artwork processes by means of three key areas: Workflow and Version Management, Approval Management and Proofing of Artworks. Since it is a web SaaS application, you can use your browser to access all your data from anywhere. Can you perhaps elaborate a bit more on your challenges so we can focus on which parts of the system might be more relevant to you?

Artwork Manager: Sure, let me provide more details on the challenges we’re facing. One of our main issues is the number of people involved in reviewing the artworks, which creates delays and bottlenecks. We also have multiple feedback rounds due to missing information at the beginning of the process, leading to numerous iterations. Additionally, we need to check consecutive versions manually, which is quite time-consuming.

Furthermore, we have no efficient way to report key performance indicators, making it hard to identify critical bottlenecks. Finally, our information is scattered across emails and shared folders, making it difficult to locate the right information when needed.

With these challenges in mind, can you explain how Twona can help us improve our process and overcome these issues?

Me: Thank you for that explanation. Let me try to answer one by one those challenges you are facing. We see frequently across our customers that there are many stakeholders involved in the review and approval process. Twona’s approval functionality allows you to manage the process in an efficient way. It works both with internal and external stakeholders (external stakeholders do not need a license for the system) and it can work both with parallel approval process as well as serial approval processes. So lets say the artwork needs to be reviewed at a certain stage, this is how it would work: You select the artwork version for which you want feedback and/or approval and then include all relevant stakeholders (both internal as part of your team as well as external, for instance CMOs, printers, etc). Twona will then send an email to all stakeholders with a link where they will be able to review, download, comment, upload supporting files and even record a video/voice message. All the relevant information will be collected in one place for you to review, without having to read one single email. To simplify the process, Twona will also notify you when all approvals have been collected. And if someone forgets, Twona will send them a reminder one week after the approval was requested and you can always send them a manual reminder directly from the application. How does that sound?

Artwork Manager: That sounds really helpful! It would definitely help to have a centralized platform for managing approvals and feedback. I’m also interested in how Twona can help with reducing the number of iterations and managing consecutive versions. Can you explain how the system addresses those challenges?

Me: A large number of iterations is typically symptom of a broken process. Twona can help you by streamlining the workflow and making sure everyone is aware of what they have to do. There are a few key bits that are relevant in that process. First of all, Twona does all the version tracking for you. Since we work with Pharmaceutical companies, Twona is very strict and compliant with market standards. Each version is uniquely identified by a number and cannot be deleted. Twona can also help you identify the state of that version: approved, obsolete, rejected by setting specific version states which are configurable and setting automation rules to set those states under specific circumstances, for instance “when all stakeholders have approved, change the state of the version to approved”, or “if a rejection is received, change the state of the version to rejected and move the project back to changes required”. Additionally, and this is not tool related but process related, we always recommend to our customers that a quality check is put in place to ensure that all information related to the creation of the artwork is correct and complete. This helps avoid iterations due to poor brief information. One additional feature that can help there, is the ability to configure brief forms to introduce all relevant information before a project is started, avoiding also the back and forth email process or unnecessary iterations due to faulty information. Does that answer your question?

Artwork Manager: Yes, that definitely answers my question. The version tracking and configurable workflow sound like they will help us minimize iterations and improve efficiency. One remaining concern is the ability to generate reports and track key performance indicators. Can you explain how Twona can help us with that aspect of our process?

Me: That is a great question. Across all our customers, we see very different needs when it comes to reporting. Some want KPIs on time to process, others want KPIs related to workload for their team. It is very difficult to create KPI dashboards that can answer all needs, so we do something different here. We provide a very powerful API that allows customers to create and configure completely customised dashboards for KPI reporting. Because APIs can be used across a multitude of systems, this provides the flexibility to create something completely tailored to your needs. One example is using Zapier, Google Sheets and Google Looker to create powerful dashboards without code. We are always happy to make a dashboard for your needs (this is usually just a couple of hours of work).

Artwork Manager: That’s fantastic! Having a customizable solution for generating reports and tracking KPIs will be really beneficial for us. It seems like Twona could be the solution we’re looking for to address our challenges and improve our artwork management process.

Before we wrap up, I have one last question. How easy is it to implement Twona into our existing processes? What kind of support do you offer during the implementation phase?

Me: That is a difficult question. We always say that we can have Twona up and running in under a week. However, in general the bottleneck is on the customer side given the complexities and number of people involved. The way we approach the onboarding phase is as follows: we assign a Customer Success Manager to you, who will guide you step by step during the onboarding and who will help gather all relevant data related to your workflow, configuration, automations, migration of data, reporting and who will also be responsible for training you team on your new tool. Your CSM will go as fast or as slow as you need depending on your current capabilities and resources.

Artwork Manager: That’s reassuring to know. It’s important for us to have a smooth implementation and a dedicated Customer Success Manager sounds like a great way to ensure that. I appreciate the detailed explanation of how Twona can help us improve our artwork management process. I’ll need to discuss this with my team, and we’ll get back to you with any further questions or to move forward with the implementation. Thank you for your time today!

Me: I have one last question before we close the conversation. What do you think would be the biggest challenge for you to get Twona implemented for your team?

Artwork Manager: I think the biggest challenge for us would be ensuring that our team adapts to the new system quickly and that we can successfully integrate it into our existing processes. Change can sometimes be difficult, and it will be important for us to have a clear communication plan and proper training in place to make the transition as smooth as possible. However, with the dedicated support of a Customer Success Manager, I’m confident that we can overcome these challenges and successfully implement Twona in our artwork management process.

April 4, 2023August 28, 2023

What in the world is AMS?

*Airport codes in illustration by SailHo Studio*

AMS is not only the Airport code for the city Twona is based in, but also used as an abbreviation for an Artwork Management System. This is a software solution designed to streamline the creation, approval, and distribution of creative assets such as packaging elements, leaflets, labels, and other marketing materials.

The goal of an AMS is to simplify and automate the often complex and time-consuming process of artwork creation and management, thereby reducing errors, saving time, and improving overall efficiency.

It also means that all data related to your artwork is stored in one place; no more versions saved on local drives claiming to be the most recent and sent around stakeholders in error, conversations and discussions in one repository ensuring transparency for all stakeholders involved and don’t forget traceability of who did what when.

There are many benefits to introducing an AMS into a company that produces any type of packaging, labels or marketing leaflets. Here are a few of the most important:

Centralised storage and organisation: An AMS provides a centralised location for storing and organising all creative assets. This makes it easier for teams to find the assets they need, and also reduces the risk of assets becoming lost or misfiled.
Improved collaboration: An AMS makes it easier for teams to collaborate on the creation and approval of creative assets. With an AMS, teams can easily share feedback and revisions, reducing the need for multiple rounds of revision and improving the speed at which projects can be completed.
Better control and visibility: An AMS provides a centralised location for tracking and monitoring the progress of artwork projects. This makes it easier for managers to see which projects are on track, which are running behind schedule, and which need additional attention.
Enhanced brand consistency: An AMS helps to ensure that all creative assets are consistent with a company’s brand guidelines. This helps to maintain a consistent look and feel across all marketing materials, improving brand recognition and credibility.
Increased efficiency: An AMS automates many of the manual processes involved in the creation and management of creative assets. This saves time, reduces errors, and improves overall efficiency.
Compliance and regulatory support: Some AMS can help companies comply with regulations and standards by automatically checking that all creative assets meet the required guidelines. This helps to avoid costly mistakes and ensures that all materials are compliant with industry regulations.
Streamlined approval processes: An AMS can help to streamline the approval process for creative assets by automating many of the manual steps involved. This reduces the time required for approval and makes it easier for teams to keep track of the status of each project.

If you are thinking that your company would benefit from an AMS, there is no harm in reaching out and talking to a few. We here at Twona would be more than happy to help you make the decision to invest in an AMS or not. We are also honest and will let you know if Twona is or isn’t right for your needs. So, get in touch today and let’s start the conversation.

March 13, 2023March 13, 2023

Artwork Management? On the Cloud, please

If you follow the news, you will have heard of the cyber attacks that many pharmaceutical companies suffered in since a few years. The pandemic, and the sheer need to work from home and for employees to remotely access their valuable data, left companies that were not well prepared for this change in terms of security measures, highly unprotected for these schemes.

Besides the obvious consequences of data loss, and potential stolen intellectual property, there are other larger results like job losses and regulatory fines. However, companies’ reputation and brand can be also affected. According to this Forbes Insight report, 46% of organizations had suffered damage to their reputation as a result of a data breach.

One of our customers was the target of such cyber attacks in 2022. A lot of their data which was sitting in internal servers was compromised, affecting several areas within the company. Employees could not access data for days, and loss of information was experienced. Luckily, the Artwork and Regulatory teams were dealing with their packaging designs using our cloud-based Artwork Management System, so they could continue working normally and no data was lost for them.

Even though the Artwork Management Software Market Share is Expected to Grow at a CAGR of 9.0% 2022 to 2028, using Cloud technologies is not always a given for Life Sciences companies. Many of them do not consider a SaaS solution when looking at a change on their artwork management system, and insist on having it installed in their own servers. The main reason for this is that they consider they can have a better control on the application, and they believe it will be more secure.

Wrong.

More secured?

Cloud service providers offer heavy physical security measures to protect their data centers: advanced security systems, including biometric authentication, surveillance cameras, or 24/7 monitoring. They also have redundancy in place to ensure that data is not lost due to natural disasters or other events. Providers will also hire security professionals solely dedicated to ensuring that their infrastructure and services are secure; and since they have access to the latest security technologies, adapting to new threats is very quick.

More control?

When it comes to “having more control” over the solution, the reality shows that, often, organizations rely on manual processes to detect any unusual activity, which can be time-consuming, prone to errors, and too late when a serious problem occurs. Cloud service providers on the contrary, have continuous monitoring in place to detect any unauthorized access or unusual activity. They use advanced security technologies such as intrusion detection and prevention systems, firewalls, and access controls. And they have the time and resources to continuosly do security audits and vulnerability assessments to identify and address any weaknesses in their infrastructure.

Furthermore, on-premise solutions may not be updated regularly, leaving them vulnerable to new threats. When updates do occur, systems often need to be shut down for a period of time, and users are not allowed to log in until the changes have been implemented and tested on the production environments. Cloud solutions are constantly being improved, and most changes do not require a full stop of system usage, as often new releases can be done within a few minutes and are transparent for the common user. This, in consequence, means that updates on cloud solutions tend to happen on a more regular basis.

One other set back for on premise solutions is that organizations may not have the resources available to scale up in case of increased usage or large growth, as this requires investing in additional own hardware and infrastructure for which one may not have the money or the floor space for! In a cloud environment, one can quickly add or remove storage capacity based on requirements without needing any extra space, and at a fraction of the cost of own infrastructure.

Considering all the above, we believe – and hope that we have also given you enough reasons to believe the same – that Cloud solutions are a better, more flexible and economical solution for companies looking at updating their Artwork Management platforms.

Our solution, Twona, is a SaaS solution, and hosted in the cloud. We review the infrastructure underneath it regularly, to make sure it is upgraded to the latest at any given time, and constantly work on ways to improve our solutions performance based on these. And, if you still need some more reassurance, I would like to add as a final notes that at Twona, we have a recovery protocol whereby in a matter of hours, we are able to replicate our set up and get our clients functioning again.

March 10, 2023

Connecting your AMS with APIs

In today’s world of tech wonders, companies require robust and efficient systems to manage their workflows, and packaging design for pharmaceutical and food companies is no exception, specially considering the complexity in the process and the number of stakeholders involved. In order to streamline the process of exchanging information during the different steps of the workflow when more than one system is involved, companies can use REST APIs.

What is a REST API?

REST (Representational State Transfer) API is an interface that allow different software applications to communicate with each other over the internet. REST APIs use HTTP requests to send and receive data, making it easier for software applications to exchange information and interact with each other.

One-directional and Two-directional communication

REST APIs can facilitate one-directional or two-directional communication between different software applications. In one-directional communication, data flows only in one direction, for instance sending an approved artwork to an ERP system. In two-directional communication, data flows both ways, allowing for a more robust exchange of information between different software applications, for instance obtaining a Material Number and providing an approval over a packaging material.

Benefits of using REST APIs for packaging design

REST APIs provide several benefits when it comes to packaging design for pharmaceutical and food companies:

Streamlined workflow: REST APIs can facilitate a streamlined workflow by enabling different software applications to share data with each other. This reduces the risk of data corruption by ensuring a single source of truth. It can also reduce the amount of time and effort required to manage the packaging design process.
Increased efficiency: REST APIs can reduce manual data entry and other repetitive tasks. This can lead to faster turnaround times, improved accuracy, and reduced costs. A good example is a Pharma company working with a CMO. Each have their own AMS and both insist in using their own for quality and audit purposes. Without an API connection, data needs to be entered in both systems, usually triggered by email communication, while an API connection can automate the data sharing process reducing in less manual work.
Improved collaboration: REST APIs can facilitate better collaboration between different teams involved in the packaging design process. For example, designers and printers can use different software applications to work on different aspects of the packaging design process, and REST APIs can be used to share data between these applications, making it easier for team members to work together.

Challenges of implementing REST APIs

While REST APIs can provide several benefits, implementing them can also be challenging:

Compatibility issues: Different software applications may use different data formats, which can make it difficult to share data between them. When such compatibility issues arise, the time and effort required to implement a connection tends to grow.
Security concerns: REST APIs can create security risks if not implemented properly. Companies must ensure that their APIs are secure and that data is encrypted to prevent unauthorized access. A good API connection implementation will always secure protocols to encrypt the data while in transit.
Maintenance: REST APIs require regular maintenance to ensure that they continue to function properly as the different systems involved change over time. Companies may need to allocate resources to maintain their APIs and ensure that they remain up to date with the latest software updates.

REST APIs offer several benefits when it comes to optimising your packaging design workflow. By enabling different software applications to communicate with each other, REST APIs can streamline the process, improve efficiency, and facilitate better collaboration between different teams while reducing manual work and reducing risk.

If you want to know more, check out our public API documentation to see how it can help your process.

March 7, 2023

Improving your Artworks Workflow

As an artwork coordinator working for a pharmaceutical company, I oversee the packaging design process from start to finish. It’s a complex process that involves multiple stakeholders and departments: regulatory, supply chain, printing houses, customers (we also do Contract Manufacturing), Quality Assurance, etc. It requires careful coordination to ensure that everything runs smoothly. Over the years, we’ve refined our process to the best of our abilities, but as with any complex system, there’s always room for improvement. We make our process work, but it requires constant emails, reminders and nudges to certain stakeholders to keep everything in check.

When we decided to purchase an Artwork Management System, we agreed to bring in an external workflow and process consultant to help us optimize our packaging design workflow as we intended to digitise our process. At first, I was a bit skeptical. After all, I knew our process inside and out, and I wasn’t sure how an external consultant could provide any value. Our initial plan was to simply move from a manual email based workflow to a digital one. However, after a couple of phone calls regarding the process, we realized that an external set of eyes can sometimes identify issues in your process that you simply cannot see because you’re too close and too busy.

The Consultant

The consultant that came in had extensive experience working with other pharmaceutical companies, not only within brands, but also in CMOs, design agencies, etc. He got us started by going thought our current process, which was drawn on a white board and asking a lot of questions as we went through every stage: who is involved, what information is provided, when, what are the challenges, what happens in this and that scenario, etc. Very quickly he was able to spot a few areas where we could make improvements. There were a couple of key aspects that were particularly interesting where he suggested some changes in the process by analysing and justifying those suggestions. The following was one of the most relevant ones:

Our Process

In the beginning of our process, the Regulatory Department provides the key information related to the change that has to be implemented in the packaging material: a new text, a set of annotated changes due to a change in regulations and anything in between. When this information is received, the Artworks Team checks it and forwards the request to the agency to execute the changes. Later in the process, once the design has been implemented, the Regulatory colleagues check the artwork to make sure it complied with their request for change. The consultant asked: how often does an artwork need to be redone because Regulatory spotted a mistake in the content (not a mistake introduced by the design agency). The answer across my team was consistent…..very frequently. The consultant then made an estimate of the amount of hours involved across all teams between the moment the request is sent by RA and the moment the design is sent back to them for changes. We calculated around 40 to 50 hours of work.

The Suggestions

His suggestion was simple: add a four eye principle on the information provided by Regulatory BEFORE the artwork request is sent to the agency. The objective was to validate the information before those 40 to 50 hours of work were spent on the artwork so that the number of iterations would be reduced. We quickly involved the QA team, who happily agreed to review the data before it was sent to the agency. It was brilliant. A simple suggestion, a nudge to the colleagues in QA and the potential time savings were incredible.

At first, I was a bit intimidated by the prospect of implementing all suggested changes. After all, change can be difficult, especially when you’re dealing with a process that has been in place for years and many stakeholders involved. However, with an open discussions and proper justification of each suggested change, I realized that these changes were all aimed at making our jobs easier and more efficient. By embracing these changes, we could reduce the amount of time and resources we spent on each project and ensure the best possible outcome. Having an external set of eyes also helped align all relevant parties (external people are not afraid of starting difficult conversations).

Over the next few months, we worked closely with the consultant to implement the changes he had suggested. It wasn’t always easy, and there were a few bumps in the road, but overall, the process went smoothly. We saw an consistent improvement in in our process. and our workflow became much more streamlined. We were able to complete projects more quickly and with fewer errors, which made everyone involved in the process much happier.

Looking back, I’m so glad we decided to bring in an external set of eyes to help us optimize our packaging design workflow. I’m excited to see what other improvements we can make in the future, and I’m grateful for the opportunity to work with such a talented consultant.

If you want an external set of eyes on your process, setup a call with us and let’s work together to make your workflow flawless.

March 6, 2023April 13, 2023

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?

Interested in hearing more?

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February 15, 2023

Be like water….

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:

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.
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.
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.
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.

February 14, 2023

5 key components of a VMP for SaaS

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.

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.
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.
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.
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.
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!

February 6, 2023February 6, 2023

AMS Twona NeXT 200mg digital pills

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.

February 6, 2023

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.

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.