The integrity of all laboratory work and cleanroom operations relies on a secure and verifiably stable chain of custody.  

To meet modern requirements, such as Good Laboratory Practice and Good Clinical Practice regulations, labs and cleanrooms need a robust traceability system that creates an auditable link between an asset and its environmental history. Such a system actively safeguards materials, simplifies compliance, and provides deep insights to protect your research.  

Here are five keys to building an airtight audit trail for your most critical assets. 

1. Precise and Continuous Environmental Data Logging 

The foundation of traceability is an uninterrupted historical record created by reliable temperature sensors and data loggers that link every asset to its specific storage history. A best-in-class system achieves this with a constant flow of precise, automatically captured data. Specifically, the system should: 

• Continuously monitor and log temperature, humidity, and other critical parameters in real-time. 

• Capture exact timestamps for every fluctuation, user interaction, and system event. 

• Allow for granular monitoring of individual refrigerators, freezers, and incubators, down to the shelf level. 

2. Real-Time Monitoring with Intelligent Alerts 

While historical data is crucial for audits, intelligent real-time alerts are essential for actively protecting your assets. For sensitive applications like cleanroom monitoring, a powerful traceability system acts as a vigilant guardian, offering immediate insight into excursions before they cause irreparable damage. Essential features of an intelligent temperature monitoring system include: 

• Fully configurable alert triggers based on specific thresholds, durations, and asset types. 

• Instant notifications for personnel via email, SMS, and phone calls when conditions go out-of-range. 

• Intelligent escalation paths to alert different team members based on the severity or time of an excursion. 

• Efficient alarm management to categorize, acknowledge, and document the complete incident response. 

3. Tamper-Proof Audit Trails and Data Integrity 

In heavily regulated GxP environments, undocumented actions are considered non-existent, making a defensible, immutable history of all activities a cornerstone of compliance. Your system must be designed to meet stringent standards such as EudraLex Volume 4, Annex 11 and the requirements of accrediting bodies, such as the United Kingdom Accreditation Service for medical laboratories. Therefore, you should look for a system that delivers the following capabilities: 

• Automatically documents every temperature excursion with details on severity, duration, and timestamps. 

• Generates a full, unalterable audit trail of all system interactions, from login attempts to acknowledged alarms. 

• Fortifies data integrity with robust security, including role-based access control and data encryption. 

• Provides all necessary data to streamline inspection responses and corrective action plans. 

4. Customizable Reporting and Data Analysis 

An abundance of environmental data is only valuable if it can be easily accessed and translated into actionable insights. A comprehensive system with powerful, on-demand reporting tools helps you analyze trends and confirm asset viability, such as: 

• Customizable reporting formats for internal reviews, specific batch histories, or external audits to satisfy the Medicines and Healthcare products Regulatory Agency and EudraLex Annex 11. 

• Historical data tracking for long-term trend analysis and equipment performance reviews. 

• Secure data export and sharing with user-specific access levels for integration into broader lab information systems.

5. Scalable Technology and Flexible Connectivity

Modern laboratories are dynamic, and your monitoring system must be able to adapt and grow without creating data silos or compliance gaps. A strong traceability system is built on scalable technology that ensures unbroken oversight as your operations evolve. Key features of a scalable system include: 

• Effortless scaling that does not require extensive construction or renovation costs from a single temperature sensor to multiple departments and facility sites. 

• Departmental customization for specific monitoring needs, workflows, and user access levels. 

• Support for various connectivity methods (Wi-Fi, Ethernet, LoRaWan, and cellular) for reliable data transmission from any environment.  

Build a More Traceable Lab With OCEAView

Protecting valuable assets and ensuring regulatory compliance with standards such as EudraLex Annex 11 requires a robust traceability solution, and OCEAView provides a powerful, centralized platform to simplify the process: 

• Smarter Alarm Management: Protect assets with smart, timely alerts that automatically log every part of an excursion event with timestamps, from trigger to acknowledgment and corrective action. 

• Compliance with Comprehensive Traceability: Simplify audits and maintain data integrity with a detailed data trail that tracks all system activity, from user logins to alarm acknowledgements. 

• Centralized & Scalable Control: Standardize monitoring protocols across all devices from a single, centralized platform to ensure a complete and tamper-proof record for continuous compliance. 

This comprehensive approach ensures your assets are protected, your lab remains compliant and your research is secure.  

Ready to ensure the integrity of your lab? Learn more about OCEAView Cloud, OCEAView On-Premises, or contact a Dickson expert with any questions.