The ROI of Pharma MES: How Investing in cGMP Compliance Saves You Money

In the world of pharma manufacturing, ensuring compliance with current good manufacturing practices (cGMP) is non-negotiable. However, the manual approaches to compliance that pharmaceutical companies have traditionally employed create hidden costs that eat away at bottom lines. Between paper records, time-consuming audits, and the potential for human error, your commitment to cGMP might be costing you more than you realize.

The good news: investing in a modern pharma manufacturing execution system (MES) can significantly improve your return on investment (ROI) by streamlining compliance efforts and minimizing costs that may initially seem benign.

The Hidden Costs of Manual cGMP Compliance

Paper-based documentation and manual processes plague many pharma manufacturers. Let's delve into some of the hidden costs associated with this approach:

• Inefficiency: Manual data entry, document management, and reporting are time-consuming tasks that divert resources from higher-value activities.
• Errors: Paper records are prone to errors during manual data entry and transcription. These errors can lead to costly rework, scrap, and delays.
• Audit Delays: Manual audits involve sifting through stacks of paper records, a tedious and time-consuming process that halts production.
• Noncompliance Risk: Human error and incomplete documentation can result in noncompliance citations from regulators, leading to production shutdowns or hefty fines.

How MES Reduces Costs and Drives ROI

The MasterControl Manufacturing Excellence MES directly addresses these hidden costs by automating key processes and providing a centralized platform for managing cGMP compliance. Here's how MasterControl’s MES delivers a positive ROI:

• Improved Efficiency: Automating data capture, electronic batch records (EBRs), and reporting frees up valuable time and resources while ensuring that all your information stays connected and in sync.
• Minimized Errors: Real-time data capture and validation minimize errors associated with manual data entry.
• Streamlined Audits: Electronic records and real-time data access enable faster and more efficient audits, minimizing disruption to production.
• Dramatically Reduced Risk of Noncompliance: Automated workflows and improved data integrity reduce the risk of non-compliance, protecting your business from costly penalties.

A Real-World Example of MES ROI

Since implementing MasterControl’s MES, contract pharmaceutical development company Almac Sciences has cut production cycles from months to days without jeopardizing cGMP compliance. Ditching paper for electronic records has allowed the Almac Sciences team to work more efficiently and perform tasks concurrently. Using MasterControl’s robust MES in the production of cGMP-compliant peptide products has enabled them to work quickly while still maintaining high standards of quality, according to the company’s production supervisor, Laura Glenn. Additionally, eliminating manual transcription processes by implementing MasterControl’s error-proof electronic production records has directly resulted in faster batch release times.

Invest in Your cGMP Compliance With MasterControl MES

MasterControl MES goes beyond cGMP compliance; it's an investment in the future of your pharma manufacturing operation. By optimizing processes, minimizing errors, and streamlining audits, MasterControl MES delivers a tangible return on your investment.

Ready to Learn More?

Download our free Manufacturing Software Buyer's Guide, a comprehensive resource to help you navigate the world of pharma MES solutions and choose a system best suited to your needs. MasterControl’s MES has a proven track record of helping pharma companies achieve cGMP compliance while optimizing operations and maximizing ROI. Contact us today to learn how we can help your pharma manufacturing business thrive.