Still struggling to gain approval for manufacturing IT investments? How pharma MES delivers on ROI

It’s no question that in the digital age, pharma and biotech production must be supported by manufacturing execution systems (MES). These systems digitize end-to-end pharma manufacturing processes – from receiving goods via warehousing through to production and packaging. Using MES results in process improvements and significant efficiency savings.

Pharma manufacturing without MES is a risky strategy

If you are still documenting your pharma production processes on paper, there is a constant potential threat of human errors, data integrity violations and warning letters. An incident can put your entire production on hold. So if you think the implementation of MES just costs money and lacks ROI, think twice.

4 reasons why MES delivers huge potential for ROI

1. MES cuts material costs: The system helps manufacturers to prevent manual errors with materials from happening. If the use of incorrect materials or expired inventory can be avoided, companies will minimize the risk of scrapped production or even recalled batches.
2. MES reduces operating expenses: As the system eliminates or automates processes that require personnel, there is no more need for verification by a second person, for example in material weighing and charging operations.
3. MES lowers work-in-process inventory costs: The system speeds up and automates processes, which otherwise hold up production, and makes data available for improved scheduling. This allows optimizing non-value-added steps, troubleshooting and clearance times.
4. MES helps reduce compliance costs: Compliance costs can be reduced because the system provides a consistent data set. Inspectors policing large pharma markets are looking in detail at the underlying recordings, systems and handling of data. Data integrity is receiving the highest attention in the industry due to the risks of failing to meet the latest regulatory expectations regarding counterfeiting, tampering and traceability. MES directly lowers the risks of data integrity issues and audit failure and therefore has a huge impact on the pharma company’s compliance record. Cost-saving side effect: MES functionalities reduce human resources needed to generate, review and approve data and documentation.

You will find more examples of MES savings in our whitepaper:
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Example of cost savings: Reduction of batch deviations by 80%

Thanks to MES, a global pharma corporation reduced batch deviations by 80% and paperwork between shifts by 60%. However, to be able to improve a process, it is important to already have sufficient data about it.

So what do you have to do for a first ROI evaluation to define goals and compare them with your status quo?

• Perform interviews with key management to identify requirements, objectives and risks
• Conduct workshops on how value of data and capability may change over time
• Analyze existing processes at a non-detailed level

You will find more examples of typical steps to evaluate ROI in our whitepaper:
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MES makes you “Pharma 4.0-proof”

MES frees companies from scattered information (exchange of paper requires effort; ERP systems cannot control and record the production) and recordings on paper which are inherently unreliable and inaccurate. If we look at other industries: Those which have not moved forward have been swept away by the massive wave of change that digitization brings. So better don’t miss the digital “Pharma 4.0 bus“.
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You have made it till the end of our blog entry – here is your reward: Read this brilliant ISPE article of the year about the holistic product control strategy as central part of Pharma 4.0.