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GxP Lifeline

Want Quality, Compliant Life Sciences Products in Less Time? Digitize Your Processes.


Image of a life science professionals using MasterControl’s digital MES, Mx, for their manufacturing excellence efforts.

In life sciences manufacturing, it’s easy to feel overwhelmed by what’s happening in the world around us. Regulations, technology, and consumer expectations all evolve faster than we can keep up with, making it even harder to create the life-changing medicine and devices people need.

But there are certain priorities that never shift for manufacturers: making high-quality products, meeting regulatory compliance requirements, managing resource constraints, and fostering continuous improvement. Get them right, and everything else comes into focus. Get them wrong, and you’ll fall behind the competition.

So, how do you ensure you always come out on the winning side?

Digitization. It’s key to manufacturing excellence. And it’s a priority for 64% of manufacturing professionals. With digitized, modern manufacturing processes, you can release products faster, ensure quality and compliance, use internal resources more effectively, and adapt more easily to market demands.

Staying Ahead With Digital Infrastructure

From digital work instructions and production records to logbooks and equipment tracking, MasterControl’s Manufacturing Excellence (Mx) software suite gives you the flexibility to adapt your operations for anything the market throws your way. Here’s how.

High-Quality Products With Less Room for Error

Paper-based processes, including handwritten entries, increase the risk of human error, delays, and inefficiencies. Manufacturing Excellence provides a centralized, paperless system to manage all your manufacturing processes—including production, asset, and inventory management.

For example, with electronic batch records (EBR) and electronic logbooks, you can reduce errors, save time spent manually inputting thousands of entries, and speed up review times with review-by-exception functionality. And, with built-in quality checks and controls, you can stop mistakes before they happen, while also ensuring regulatory compliance and product safety.

Consistent Compliance Without the Stress

If you’re still making entries in and reviewing batch records by hand, ensuring your production process meets regulatory standards isn’t easy. Manual processes take up massive amounts of time, increase the chance for error, and push up your audit risk. Not to mention the frantic search for a lost paper batch book while an auditor waits down the hall.

Switching to digital can help you take those stress levels way down. Standardized digital processes and automated audit trails in our Manufacturing Excellence software ensure consistent quality and make it easier to comply with regulations.

Faster Approvals and Speedier Product Releases

Manually reviewing a set of work instructions or standard operating procedures (SOPs) here and there might not seem like it would slow your time to market. But every hand-written or manually reviewed document lowers employee productivity and increases cycle times.

With digital transformation, manufacturing processes and product releases can be sped up through digital workflows that accelerate review and approval cycles. For example, using the electronic device history records (eDHRs) in Mx, you can automate document control tasks, reduce errors, and keep reviews on schedule.

When employees no longer have to worry about tedious, time-consuming tasks, they’re free to focus on the work that gets your products to market the fastest.

Right-First-Time Production and Continuous Improvement

When employees enter data by hand, your data integrity inevitably will take a hit. Poor data can extend review cycles, increase preventable errors, and result in costly waste. MasterControl’s life sciences MES offers rich operational data and real-time dashboards to help you stay on top of manufacturing performance and proactively resolve issues.

It’s how Dendreon, a maker of cellular therapeutics, maintains a 99% right-first-time metric. Using advanced analytics and reporting capabilities, you can continuously refine processes to maintain high standards, reduce waste and rework, and stay compliant—while at the same time, swiftly introducing new solutions to advance human health.

Personalized Peptides Made With MX

Since peptides can’t survive long production cycles, Almac Sciences had to rethink manual ways of recording, dating, and signing to speed up their processes and stay audit-ready.

The company, which makes personalized peptides for use in individualized cancer vaccines, uses MasterControl’s electronic batch records to shorten batch book review time, streamline audits, and enhance manufacturing quality management.

“When we’re audited by both clients and regulators, they love it because we can get MasterControl on the screen and show them as soon as they ask.” — Martin Ross, Quality Manager, Almac Sciences

 

Don’t Make Manufacturing Harder—Make It With Mx

Reaching true manufacturing excellence doesn’t have to be complicated. Even though market conditions and other factors are outside of your control, transforming the way you work is a choice you can make today.

Start small by digitizing just one production line. And when you’re ready, connect all of your manufacturing data, processes, personnel, and systems.

Make the products that change people’s lives. Make it easy. And make it with Mx.

To learn how other life science companies are getting ahead by digitizing their processes, download the “Made With MX Ultimate Guide.”

 

mastercontrol-executive-team-2023

MasterControl Inc. is a leading provider of cloud-based quality and manufacturing software for life sciences and other regulated industries. For three decades, our mission has been the same as that of our customers – to bring life-changing products to more people sooner. MasterControl helps organizations digitize, automate, and connect quality and manufacturing processes. Innovative MasterControl tools have a proven track record of improving product quality, reducing cost, and accelerating time to market. Over 1,100 companies worldwide use MasterControl solutions to streamline operations, maintain compliance, easily analyze and interpret large amounts of data, and visualize business insights in real time.


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