Real-time insights, one-click sign-offs, data-driven efficiency... Picture your biopharmaceutics production in a world where every step of your Good Manufacturing Practice (GMP) workflows is streamlined, digitized, compliant, and optimized for your unique needs.

This is not a fairytale, it's the near future! But not everyone feels ready for this change just yet and many companies struggle to make the transition to digital workflows. According to a 2021 Deloitte survey, a striking 49% of biopharma leaders felt that their digital transformation strategy needs improvement [1].

That's why in this blog post, we're here to guide you through three essential steps to digitalize your GMP workflows and standard operating procedures (SOPs) with ease and confidence. These steps provide a roadmap for all biopharma innovators, production managers, and QA professionals to overcome common hurdles and make the digitalization process smoother and more successful.  

Unlock the full potential of your GMP workflows and enable your biopharmaceutical organization to flourish.  

Wondering how? Simply follow our guide to digitalization, driven by three simple yet powerful rules: think big, start small, iterate fast.  

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Rule 1: Think big.  

When it comes to digitalizing GMP workflows, adopting a big-picture mindset is key to success. It's important to start with the end in mind and create a digitalization roadmap that takes into account the big picture of your operations.

When preparing for your digitalization efforts, consider a few crucial factors. Sticking to this strategy will ensure that your digitalization project is not just successful, but sustainable in the long run. The important first steps are to:  

1. Assess the maturity of your processes and tailor your digitalization plan accordingly

2. Evaluate the software solutions available on the market based on your needs.

3. Plan and provide employees with training and support.

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1. Assess the maturity of your processes and tailor your digitalization plan accordingly.

First, consider any inefficiencies and find the pain points that interfere with your current GMP processes. As an example, traditional paper-based processes often result in manual data entry errors, misplaced paperwork and unscalable operations. This means a lack of traceability and real-time decision-making, leading to wasted time and increased risk of errors. By identifying your pain points, you can take the first step towards developing an effective digitalization plan that eliminates inefficiencies based on your organization’s objectives.

Additionally, to strategize a future-proof digital transformation of your GMP processes, it's important to properly identify your needs and requirements.  

• GMP regulatory compliance (i.e. for software as stated in 21CFR11 part 11) is non-negotiable in the highly regulated biopharma industry, so it’s essential that your digitalization solution meets all regulatory requirements and provides compliant documentation by default.
• Flexibility is another key need - with so many moving parts in GMP production of biotherapeutics, efficient, agile and automated scheduling can be a game-changer.  
• Don’t forget about communication - seamless collaboration across departments and stakeholders can unlock new levels of efficiency and productivity.  

By identifying these needs and incorporating them into your digitalization plan, you can set your biopharma operations up for success.

2. Evaluate the software solutions available on the market according to your needs.

The market of digital solutions for biopharma is still not expanding as rapidly as in other fields. Nonetheless, careful selection of the most suitable software and services for the digitalization of your GMP SOPs and management is essential for the success of your mission.  

Make sure you involve your team members in the process of assessing your company’s needs and existing solutions. The people most familiar with manual, paper-based workflows can provide you with insights into what the alternative, digital workflow could or should look like. They are the people with firsthand experience of the challenges of manual, paper-based workflows.  

When evaluating digital solutions for your GMP workflows, consider the following factors:

• Custom or off-the shelf product?
  Decide whether you need a tailored solution, with customizable features and service, or an off-the-shelf, standardized platform. Do note that the validation requirements for custom software can be significantly higher than for off-the-shelf products.
• What kind of technical support is available?
  Check if the provider offers technical support and whether it meets your needs in terms of response times, training, business continuity strategies and valdation requirements. A reliable service provider can be the backbone of your digital transformation, whether you need comprehensive support or occasional technical assistance.
• Does it operate offline/on-premises/in the cloud?
  Cloud services are the most popular as they combine scalability, cost-effectiveness and robust data security with the ease of connectivity. On-premises service might be preferred for low latency applications or data privacy concerns in some cases. It's important to carefully evaluate these factors and consider the specific needs of your organization when deciding between cloud-based and on-premises solutions. ‍
• Is it intuitive and easy to use?
  Ensure the solution is user-friendly, even for non-technical staff. Well-designed user experience (UX) and user interface (UI) can notably boost the efficiency of your processes.  ‍
• Is it scalable?
  Especially for systems that are installed locally, check if the solution can handle increasing volumes of processes, data, and users and support your future growth. ‍
• Does it integrate well with my existing systems?
  In order to prevent copy-pasting data from one data silo into another, interoperability is key. Selecting a cloud-based software platform with a well documented API will facilitate the integration with your ERP, QMS or MES.  ‍
• Does the pricing model include a subscription plan with regular updates?
  In today's rapidly advancing technological landscape, opting for Software-as-a-Service (SaaS) is the most sustainable solution. Instead of settling for outdated static software licenses, you can ensure that your organization operates using the most innovative features. The ongoing support and continuous updates adapt the software to your evolving business needs.  

3. Plan and provide employee training and support.

The market of digital solutions for biopharma is still not expanding as rapidly as in other fields. Nonetheless, careful selection of the most suitable software and services for the digitalization of your GMP SOPs and management is essential for the success of your mission.  

Make sure you involve your team members in the process of assessing your company’s needs and existing solutions. The people most familiar with manual, paper-based workflows can provide you with insights into what the alternative, digital workflow could or should look like. They are the people with firsthand experience of the challenges of manual, paper-based workflows.  

When evaluating digital solutions for your GMP workflows, consider the following factors:

Employee training and support are often overlooked in the rush to adopt new technology, but they are critical to the success of any digital transformation effort.  

Without proper preparation and assistance, your employees may feel overwhelmed or resistant to the changes. This leads to slower adoption rates and lower productivity.

You should provide thorough training and ample time to experiment with the new technology. This will help your employees to feel more comfortable and confident using the new technology.

Rule 2: Start small.  

In any digital transformation journey, it's crucial to secure an initial "quick win" to build momentum and confidence among stakeholders.  

So, how do you identify the key which unlocks a successful digital journey?

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A perfect starting point is identifying the area of your GMP processes that is the most standardizable, generates substantial paperwork, and contributes to overall quality. Small-scale digitalization of these processes can quickly yield impressive results, boosting your organization's confidence in tackling larger, more complex operations. It also gives you a sandbox environment for testing and refining the workflows before you scale up your digital operations.

What about the specific biopharma/CDMO areas that meet these conditions?  

In most biopharmaceutical environments, the most reliable starting points for digital transformation are cleanroom cleaning or viable environmental monitoring processes. These two domains generate tremendous amounts of regulatory paperwork, not only because of their compliance requirements but also due to their frequent execution. The processes are repetitive and standardized, and the detailed paperwork takes a lot of time to be reviewed.  

Digitalization of your cleanroom cleaning processes is a straightforward task with software like MyCellHub. But how do you know your processes are ready for it?  

To help you assess the readiness of your processes, we developed this handy cleanroom cleaning digitalization checklist. Check all the boxes to get the best results from the very beginning of the digital transformation of your GMP workflows.  

Cleanroom cleaning digitalization checklist:

1. Develop a project management timeline. Make sure it’s feasible and consult it with the team members. Get inspired from our template.

2. Make a list of all the buildings and rooms that are part of the cleanroom cleaning operations.

3. Organize your cleaning masterplan. You can use our template tailored for digitalizing cleanroom cleaning processes as a start. It will allow you to automatically upload the masterplan to the MyCellHub platform.

4. Review or develop standard operating procedures (SOPs) concerning tablet usage in the cleanrooms. Make sure you know how to bring the tablets into the cleanroom.  

5. Check your Wi-Fi coverage and make sure it’s sufficient for data transfer in every part of the building involved in the processes you want to digitalize.

Now that you’re ready, it's time to kickstart your digitalization journey! Reach out to our team of experts at MyCellHub and we'll help you navigate through the process, optimizing your cleanroom cleaning workflows for maximum efficiency.

Rule 3: Iterate fast.  

As soon as you’ve successfully integrated a digital workflow into one area of your GMP processes, scaling up your digital operations in other areas will be a walk in the park. For the best outcomes, keep in mind these few tips we live by when expanding our clients’ digital workflows:

1. Foster a digital culture in your organization.

Engage all stakeholders and departments from the start to create a strong foundation for your digital transformation journey. Make sure you:

• Cultivate a digitalization mindset, encouraging employees to embrace new technologies and processes.
• Promote teamwork and sharing of data and insights. Collaboration will lead to a more unified and efficient digitalization process.

2. Embrace data analytics

Leverage automatic data collection and analytics to continually monitor and optimize your processes. By tracking key performance indicators (KPIs), you can identify areas for improvement, maximize efficiency, and ensure your organization stays ahead of the curve. Using data will also help you to get buy-in from the C-suite by illustrating the business case for digitalization.

3. Let the right tools drive the digitalization process.

Choose a comprehensive solution that will be your ally throughout the entire digital transformation process and beyond. Take advantage of solutions like MyCellHub, which are designed to support and streamline the ongoing expansion of your digital transformation.  

With MyCellHub, you'll enjoy:

• A dedicated customer success team that provides guidance and support throughout your digital journey.
• An off-the-shelf, highly configurable platform that adapts to your organization's unique needs.
• Built-in validation features, eliminating the need for developing extensive validation procedures and accelerating your digitalization process.

Biopharma's digital future starts now  

Digitalization isn't just about swapping out paper for pixels. It's about reimagining the biopharma landscape, painting it with broad strokes of innovation, agility, and precision. It's about connecting the dots of data, decoding the patterns, and using these insights to drive decisions faster than ever before. It’s about making life-saving biotherapeutics, like gene and cell therapies, more sustainable, less expensive, and delivered to the patients as fast as possible.

By adopting the strategies we present in this article, you'll be better equipped to expand digitalization across your organization. This will surely lead to improved efficiency, enhanced collaboration, and a more agile and innovative working environment.  

So, don't wait – embrace the future with confidence, and embark on your GMP workflows digital transformation journey today!

And don’t forget: Think big. Start small. Iterate fast.  

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