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   What You'll Learn  

  • MES operations burden and compliance pressures in regulated manufacturing  
  • When outsourcing improves uptime, data integrity, and cybersecurity  
  • SLA-driven support models for scalable MES performance  
  • How expert partners sustain FDA/ISO alignment over time  
  • Paths to redirect resources toward R&D and growth initiatives  
  • Options to extend MES with low-code for unique processes  

    Why It Matters

  • Reduced risk from outages and security incidents via proactive monitoring  
  • Faster issue response with the right resource at the right time  
  • Continuous improvement through best practices and new capabilities  
  • Stronger audit readiness under FDA 21 CFR Part 11 and ISO 13485  
  • Refocused teams accelerating product innovation and time-to-market

   What You Can Share with Others   

  • One-page MES outsourcing rationale summary (audit-friendly)  
  • SLA checklist for uptime, response, and data integrity  
  • Role mapping for internal vs. partner responsibilities  
  • Extension ideas using low-code to fit unique workflows  
 

 

Download the executive brief

Get the 5-minute guide to outsourcing MES without sacrificing compliance.

FAQ

Q: What problems does MES outsourcing actually solve? 
A: Run-state monitoring, patching, incident response, and compliance upkeep that drain internal teams.  

Q: Will we still meet FDA 21 CFR Part 11 and ISO 13485? 
A: Yes—specialist partners maintain controls and documentation aligned to these standards.  

Q: How are uptime and security measured? 
A: Through SLAs covering availability targets, ticket response, and cybersecurity hygiene.  

Q: What if our MES needs unique workflows? 
A: Extend with low-code to meet site-specific processes without heavy custom code.  

Q: Does this only apply to Siemens Opcenter? 
A: Examples reference Opcenter and related solutions, but the principles apply broadly.  

Q: How quickly can teams refocus on innovation? 
A: Transition plans shift routine MES work off your plate so R&D can accelerate.