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Master Data Integrity in Pharma Manufacturing

Highest level of compliance with the zenon Software Platform

Discover how COPA-DATA's zenon Software Platform ensures highest data integrity and compliance in pharmaceutical manufacturing in accordance with ALCOA principles.  Explore FDA 21 CFR Part 11 and EU GMP Annex 11 regulations, avoid pitfalls, and unlock transformative features. Download now to secure your operations and power up your pharmaceutical projects.

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Leading pharmaceutical companies put their trust in zenon

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Highlights & Benefits

Full Compliance Assurance 🛡️

  • Achieve FDA 21 CFR Part 11 and EU GMP Annex 11 compliance with zenon's out-of-the-box features.
  • Enjoy a fully configurable audit trail with eSignature capability for traceable record changes.
  • Navigate the complexities of Part 11 regulation effortlessly with zenon's parameterization philosophy, reducing validation efforts. 
  • Ensure compliance at every project development stage with native communication and integral functionality.

Digital Transformation 🌐

  • Bid farewell to traditional paper documentation by using zenon, which enables digital data recording through mobile devices and machine panels.
  • Enhance efficiency by eliminating the need for paper checklists and ensuring accurate, legible, and tamper-resistant records. 

Error prevention 🤖

  • Empower your team with zenon's user-friendly interface, reducing the risk of data integrity concerns stemming from insufficient technical knowledge. 
  • Automatic detection of incomplete or incorrect entries minimizes human errors. 

Advanced Security Measures 🔐

  • Address data integrity issues in accordance with ALCOA principles by implementing robust security controls.
  • Safeguard against accidental data loss with secure and compliant backups. 

Risk Reduction & Quality Assurance 📝

  • Reduce risks associated with third-party system interfaces, as zenon connects with full bi-directional data exchange. 
  • Maintain the zenon basic design while configuring modules to meet specific requirements without affecting overall project validation status. 

 

Comprehensive Regulatory Support 🤝

  • Leverage COPA-DATA's commitment to quality through a strict internal company quality management system. 
  • Receive support for software validation through postal and on-site audits, ensuring zenon's compliance with life-science industry guidelines. 
Don't miss out on this invaluable resource -  enter your email to download now and elevate your pharmaceutical manufacturing processes with zenon! 📥
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Full compliance with industry regulations

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Need information, advice or assistance with your project?

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