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Cheat Sheet: Arguments to Build your Case for Automated EM

Changing your entire Environmental Monitoring (EM) program can be daunting and convincing stakeholders to invest in automated EM requires more than just highlighting efficiency gains: it’s about proving long-term value, compliance readiness, and scalability.

This cheat sheet gives you the key arguments to confidently build your case, backed by industry trends, data integrity needs, and real-world results.

Today, 62% of Companies do not measure the cost of non-quality - representing a critical gap in operational performance management. This assessment is essential to map the cost-generating activities and how digitalization and automation can contribute to reduce them1.

 

This list is based on testimonials from Quality Control Experts Alicia Ruiz, and Jakub Dragun, who has recently made the shift to automated EM with 3P® ENTERPRISE.

 

What you should highlight in your business case

 

 

Gaining operational excellence – and reducing costs  

  • Quantify the time spent on investigations due to manual errors, and consider how many departments are involved. The hidden cost adds up quickly.  Investigation costs could add up to more than €400,000 with more than 10% linked to data integrity issues2.
  • Quantify your history of human errors in visual enumeration and data handling. CFU counting errors such as overgrown plates, merging colonies,.. could account for up to 30% of enumeration errors in case of very small events3. Automation would help bring consistency and reduce that rate.
  • Quantify your history of secondary contaminations occurring during manual sampling and handling.
  • Assess your scalability potential: once implemented in one facility, the system is simple to replicate across sites.

 

STAYING COMPLIANT

  • Align with the latest GMP expectations, including Annex 1 requirements with improved:
    • Data integrity and traceability
    • Contamination control strategy (CCS)
    • Mitigation of human errors in aseptic environments
  • Ensure full data traceability and availability, 24/7

 

USING YOUR TEAMS MORE EFFICIENTLY - AND RETAINING TALENTS

  • Talents will focus their energy (and their minds!) on added-value tasks such as improving processes or solving problems, making a better use of your human resources.
  • Empower your team by removing repetitive, low-impact tasks — boosting engagement and retention.

 

Supporting your sustainability goals

  • Significantly reduce paper usage.

 

PEER VALIDATION

Many experts across the pharmaceutical industry are already making the shift! Learn about their stories, lessons learnt and successes of implementing automated environmental monitoring in their facilities.

 

2 bioMérieux internal analysis based on market survey (n=40 customers; 66% traditional pharma products, 17% Cell & Gene therapy, 17% Bioproducts

3 Detection of Small events in environmental monitoring – how accurate is the visual inspection – Laurent Leblanc, Katia Imhoff, 2020