Taking Pharma Quality Assurance to New Heights

Accelerating Issue Resolution

Despite the guardrails provided by an MES, issues can occur. The cause might be as simple as an operator adding the incorrect amount of a substance during a manual addition. Or as complex as raw material variability reported by a supplier.

A robust MES helps you achieve resolution of these issues faster in two important ways.

First, the system enables “review by exception.” An EBR eliminates the time-intensive line-by-line confirmation of manual data entries. Instead, quality reviewers can focus on critical process exceptions – like an out-of-specification production reading that may directly affect the quality of the product.

The MES can identify these exceptions as they occur and report them to the right people via a dashboard to enable real-time correction and optimization.  

Second, the system delivers complete genealogy and traceability. When a deviation does occur, the MES allows you to quickly identify all batches, lots and raw materials that were impacted. Root cause analysis investigation time can be reduced by as much as 30%, because the system tracks each step in the process – and all production-relevant resources including material, equipment and personnel.

Better Quality. Better Operations.

A holistic MES is designed to help you run and monitor your operations in real time. And it also provides richly contextualized data that’s ripe for analysis.

Because the system provides so much context around a specific batch including the product, materials and equipment used, even a manual analysis can quickly uncover insights into your process.

For example, MES data can show you how many deviations occurred in a specific time frame and which step of the process had the highest occurrence. This can lead to not only insights, but actions that can reduce impacts to quality – like adding electronic verification for a manual step or updating operator training. 

Taking it a step further, analytics tools can help you correlate MES data with information from other systems. For example, adding data, such as temperature, humidity or particulate counts from your building management system, can help determine if environmental factors had an impact – guiding you to the root cause of the issue.    

Extending Gains and Keeping It “Evergreen”

While an MES can significantly improve operations in a specific production facility, you can extend those gains by applying a common MES across your manufacturing footprint.

Oftentimes, a company’s production facilities have evolved over time – each in their own unique way. Some were established decades ago. Others are the product of mergers and acquisitions.

Regardless of the cause, the result is even plants within the same parent company can operate very independently.

An enterprise MES delivers a holistic view across all your production sites, leading to larger datasets, more robust insights – and more ways to make improvements. Because procedures and recipes can be shared, improvements identified at one site can be applied companywide.

And when you choose an MES that takes an “evergreen” approach to system upgrades, you can cost-effectively maintain your continuous improvement momentum.

Unlike many MES solutions, an evergreen MES allows you to incrementally upgrade the core functionality of your system, while preserving the master data and batch records of your sites. The result? Your system stays up-to-date without the cost of additional customization and new recipe validation.

Learn more about how you can improve quality throughout your manufacturing process – and deliver products to the market – and patients – faster.

Ryan Campbell, Technical Consultant, Life Sciences Industry, also contributed to this blog post.