8 Questions to Ask When Evaluating an MES

Pharma is getting a makeover. And it’s all thanks to manufacturing execution systems (MES).

MES solutions are disrupting drug development and manufacturing. From accelerating time to market while reducing costs and ensuring production is safe, secure, and auditable, the benefits these digital solutions offer are almost endless.

In this article, we’ll explore the purpose and value of MES solutions. We’ll then walk through eight of the top questions to ask when evaluating an MES for your organization.

Jump to…

MES: An Overview

What is an MES?

An MES, also known as a manufacturing execution system, tracks and monitors the manufacturing process from start to finish. For life science companies, MES allows users to track and document the transformation of raw materials to finished goods.

What is an MES in pharma?

In the pharmaceutical space, MES can help scientists manage operations throughout the drug production lifecycle. Pharma-based MES solutions allow teams to oversee resources, maintain records, and execute batches seamlessly across teams and sites.

Pharma-based MES solutions provide a means to digitally log and transfer massive amounts of trial data, as well as adjust batch recipes and processing in real time.

How is MES different from traditional manufacturing?

Traditional manufacturing relies on physical or “digital” paper (such as Microsoft Word) to outline processes, oversee operations, and maintain records. As such, data is often disparate, hard to decipher, and riddled with errors.

In contrast, MES solutions digitize pharma and biotech production, thereby streamlining manufacturing processes such as data capture and transfer. As a result, efficiency increases — saving time and money — and risks are reduced because quality issues and process deviations can be caught in real time.

Why are MES solutions necessary?

Jim Rohn once said, “Time is more valuable than money. You can get more money, but you cannot get more time.”

And he was right.

Drug manufacturing companies work against the clock. From bringing new therapies to market and delivering life-saving vaccines (hello COVID), as well as manufacturing drugs for the millions of people who rely on medication to manage chronic conditions, time is of the essence.

That’s why traditional, slow, paper-based processes no longer cut it. Instead, MES solutions are necessary so that companies can monitor production from raw materials to finished products with speed and accuracy.

Now, Let’s Explore the 8 Questions to Ask When Evaluating an MES Solution:

MES Question #1: Is Coding Knowledge Required?

Rather than ending up with a solution you don’t know how to use (or even worse — can’t), make sure to ask about the coding knowledge required upfront. Otherwise you could end up with a solution that isn’t easy to use and requires expert knowledge to maintain.

In terms of coding, MES solutions fall into one of three categories:

• Full-code
• Low-code
• No-code

For full-code MES, you basically need to be protégé Dennis Ritchie, aka the “Father of Modern Computer Programming.” These solutions use traditional programming to create applications — meaning everything is built by the user. Full-code MES requires users to have software engineering experience.

In contrast, low-code MES solutions have pre-built, plug-and-play components. Users don’t need to have deep expertise in programming to use low-code systems, but some basic knowledge is required to maximize output. Specifically, low-code MES still requires some coding to configure the components and customize the system.

Finally, no-code MES solutions are entirely pre-built and require no coding whatsoever. This allows any part of an organization — regardless of engineering background — to easily grasp and use these solutions.

Since non-coders can take the reins on no-code MES customization, dedicated coders can be freed up for more technical projects, providing massive benefits to resourcing and onboarding for both teams.

MES Question #2: What Features Are Provided?

In order to select the right MES for your organization, it’s important to learn the capabilities and features that are available. And that’s not all — you’ll also need to understand which of these features are crucial to your manufacturing operations, and which are just nice-to-haves.

When evaluating MES functionality, look for features such as:

• Collaborative recipe authoring tools
• Parameterized and generic recipe templates
• Equipment management tracking
• Built-in conditions and exceptions
• AR overlays, photos, videos, and audio

Above all, make sure that these features will be intuitive to learn and relevant to your team’s workflows.

MES Question #3: What Integrations Are Available?

Once you know the coding and configuration requirements of your MES, you can dig a little deeper into the integrations. Specifically, you can determine how the integrations will work across critical systems and equipment.

Tailor this question based on your platform and protocol needs. For example, some common integrations you may want to verify are: 

• Ignition SCADA
• OSIsoft PI
• Veeva
• OPC UA

MES Question #4: How Accessible Is the Data?

Data isn’t useful when it’s disparate or hard to access (remember, you’re running away from paper-based processes… not continuing the cycle). As such, you’ll want to make sure the MES solution you choose easily surfaces the data you need, when you need it.

When data is easily accessible, it streamlines the drug manufacturing process, making batch production and collaboration more efficient. Plus, any manufacturing problems that appear can be solved in real time, thereby saving time and money.

MES Question #5: Is It On-Prem or Cloud-Based?

On-prem MES solutions require expensive hardware, ongoing maintenance, and regular updates. In contrast, cloud-based solutions are highly secure, easy to deploy, offer better accessibility, and are more cost-effective.

That’s because cloud storage removes the need for physical servers and dedicated IT professionals to service them. Since cloud storage isn’t individually owned, companies can only pay for what they need and adjust resourcing as they scale their business.

Want to learn more about the cloud? Check out our article that answers the top 10 cloud questions.

MES Question #6: How Will an MES Reduce Manufacturing Costs?

When selecting an MES solution, you’ll want to determine the specific cost-reduction benefits offered. Depending on the platform you select, benefits could help you to:

Do your research, and don’t be afraid to ask pointed questions. For example, if a platform you’re evaluating promises to reduce labor costs or increase reliability, ask them how it’s able to achieve this.

And see if they have any statistics or case studies to back up their claims. At the end of the day, it’s all about the bottom line… and numbers don’t lie!

MES Question #7: How Does an MES Maintain Regulatory Compliance?

In pharma, compliance is of the utmost importance. Governing and regulating bodies enact various laws to ensure the safety, quality, and efficacy of drugs throughout the manufacturing process.

As such, you’ll want to inquire about how regulatory compliance works and whether it’s built into the solution.

Here are 3 questions that can help you dig deeper:

1. Is the system compliant with global pharma standards and regulations?
2. How does the MES maintain compliance and address ongoing regulatory requirements such as validation, audit trails, record-keeping, and data integrity?
3. How difficult will the compliance process be on your end — will the process be made easier for end users, or will there be additional complications and hoops to jump through?

MES Question #8: How Easily Can It Be Learned and Adopted?

Above all, don’t forget to make sure the system is actually usable. There’s no point in wasting time or money on a solution that doesn’t deliver on its promises.

Remember, MES solutions are designed to streamline processes to help you produce a higher yield of a high-quality batch, more quickly.

Look for easy-to-use functionality features, such as:

• Intuitive UI/UX
• Integrated mobile devices
• No-code configurations
• Robust user documentation and training
• Augmented reality overlays
• Group editing tools

Don’t get stuck with a complicated solution that is difficult to learn. If you do, adoption rates will be low and you won’t reap the benefits you stand to gain from incorporating an MES into your toolset.

References