Monitoring, Alarming, Reporting & Mapping for Biorepository Storage Conditions

Biological Storage Temperature: Assured Compliance

For monitoring with alarming, real-time and historical data trending, and compliance with the reporting requirements of all major regulatory bodies, the viewLinc solution is the simplest, most secure system for biorepositories and biological sample storage.

Veriteq's monitoring system viewLinc™ ensures compliance and meets best practices with:

• FDA/CBER
• ISO 17025
• AATB, AABB
• ISBER

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Maintaining Compliant, Secure Biological Storage Conditions

As the demand for biologicals, stem cells, and other human cell and tissue products increases, so do the regulatory requirements for reporting on storage conditions of biological samples and Human Cell and Tissue Products (HCT/Ps). Veriteq provides monitoring, alarming and validation solutions that protect irreplaceable products and specimens and ensures compliance with regulatory requirements.

To ensure your facility meets all requirements of FDA Title 21 CFR Part 11, the viewLinc solution comprises a network of self-powered, highly calibrated data loggers equipped with large autonomous recording capacity and a 10-year battery. Each logger ensures that no single point of failure in your facility can lose data—your temperature records are immune to any power or network failure.

The viewLinc system provides a secure audit trail of storage conditions— from cryogenic to higher temperature applications. Veriteq’s VL1000/1400 series data loggers— ideal for use in ultra-low-temperature freezers with temperatures to -90°C— viewLinc software provides fail-safe tracking of temperature data.

Safeguarding Biologicals: Customizable Reporting & Alarming

Veriteq's viewLinc system lets you create customized reports and schedule delivery via email on a user-defined schedule. High and low level thresholds can alert personnel in case of temperature excursions in discrete zones or equipment. Customize alarms to your repository's environmental needs, ensuring the right people receive detailed alarm messages by cell/pager, text, and email. Or set up dial-out phone, audible/visual alerts.

Easy to deploy and use, viewLinc provides:

• Secure, gap-free, redundant data for each monitored biological storage or processing environment within a wide range of temperatures;
  
  
• Protection for irreplaceable specimens— 24/7monitoring and alarming with descriptive alerts sent to various local and remote devices and multiple personnel;
  
  
• Simple deployment on your existing Ethernet network in any combination of wired or WiFi;
  
  
• Automated email report delivery— audit-ready alarm and data reports are always on hand, saving time and ensuring your records are up-to-date.

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viewLinc System Features: Accessible, Scalable, Cost-Saving

> Browser-based & Easy Access

Monitor and report using any standard Internet browser.
No need to install or validate software on individual workstations; unlimited users fall under a single license.

> View Environments in Real-Time

See live graphical data from any zone or environment with one click.
No extra steps to create trend views.

> Flexible Alarm Management

Establish alarm notification with text & email to PC, cell phone and
pager. Annunciate alarms through dial-out, lights and buzzers.
Set delays and acknowledgement response times, and escalate
unanswered alarms.

> Consistent Alarm Acknowledgements

Set up a menu of common temperature alarms and actions (also humidity alarms, etc.) to ensure consistency. No need to struggle with a user's interpretation of a problem.

> Audit Trail for 21 CFR Part 11 Compliance

Ensure you always have a complete audit trail with all interactions accurately and securely recorded.

> Calibration Made Easy

Receive automatic notification via email when equipment is due for
calibration — one less thing to remember for maintaining compliance. Long-term plans are available to reduce cost-of-ownership.

> Highly Secure

Use Windows authentication for another level of security. Assign access
rights for viewing and generating reports, acknowledging and
configuring alarms, or full control.

Comprehensive Support: Installation, Calibration, Training

Combining proactive support with full service, Veriteq reduces your cost of ownership:

> Onsite installation is available. Ask about our training options.

> Validate the system in-house with our IQ/OQ validation documentation, or have a Veriteq professional validate on-site.

> Rapid support for the life of the product — onsite and online... worldwide.

> Validation Rental systems — short-term without capital expense. Rental fees can be put towards the cost of a purchase.

> Calibration plans — A2LA-accredited, ISO 17025 laboratory; receive NIST-traceable certification with each device.

Versatile Recorders — Mapping, Expansion & Backup

The same recorders used for monitoring can also be employed to:

• Map temperature profiles to identify warm and cold spots in refrigerators or freezers.
• Provide redundant backup monitoring for your existing system.
• Add on to your existing centralized monitoring system with our recorders that communicate with any OPC compliant equipment.

Learn more about creating a customized solution for your biorepository monitoring, alarming and reporting needs. Email us, use the form on this page, or call 800-683-8374 (North America) 1-604-273-6850 (International calls).