Case Study: 21 CFR Part 11 Freezer Monitoring, Alarming & Documentation

“We not only improved the quality and availability of our documentation, but we can now provide a higher level of detail to the FDA and our [client] pharmaceutical companies.” 

- Senior Lab Manager, DaVita Clinical Research

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Reduce the Risks of Error/Infrastructure Failure

When the investigators at DaVita Clinical Research (DCR), which conducts clinical trials for the pharmaceutical industry, decided to automate and standardize the temperature monitoring system in all laboratory freezers and refrigerators, they needed a system reliable enough to provide a complete audit trail and gap-free data — even in the event of a power outage or network interruption.

Based in Minneapolis, DCR works with major drug and device sponsors, performing hundreds of clinical trials. Their work guides pharmaceutical advancements from initial human trials through US Food and Drug Administration approval. Applications include maintaining samples of blood, urine, dialysis and pharmacokinetic samples used in the trials, which are stored in lab freezers at -70°C and -90°C.

Sample storage temperatures must be continuously recorded and thoroughly documented to satisfy the requirements of both DaVita Clinical's pharmaceutical client companies and the FDA.

Stability: The Key to long-term accuracy

Many of these samples are kept for weeks and even months, making temperature stability even more important. At stake is the integrity of the samples, the validity of the trials, and the reputation of DCR as a leading research center. DCR wanted to move from an outdated Chart Recorder system to a fully automated approach.

It was critical to reduce the risks associated with fluctuating temperatures because many of the freezer doors were unlatched several times a day. The monitoring system would not only have to record the temperatures and compile those data, it would also need alarming capabilities.

There were multiple options, but the most accurate and economical one turned out to be viewLinc, Veriteq's Temperature Monitoring system. The viewLinc system not only monitors and alarms temperatures in critical applications, it provides validatable 21 CFR Part 11-compliant records, which DCR requires for its clients in pharmaceutical development and production, and the FDA, which regulates clinical trials.

Reporting & Documentation: Compliance with Part 11

Under the guidelines of 21 CFR Part 11, regulated applications require hybridized record keeping: electronic records as well as signed paper ones. Once the electronic records are created, they cannot be modified; they are printed and signed by DCR statisticians with full assurance that they are an accurate representation of the recorded data.

The viewLinc system employs compact low temperature data loggers equipped with long-life batteries and on-board memory. This means the temperature data of any monitored point is immune to loss due to power or network interruption.

DCR was able to implement a highly-accurate, time-based system of temperature monitoring — as well as ambient humidity monitoring — that completely updated their lab processes. The system also removed the potential for recording errors or variations in temperature that might be caused by opening the freezers and refrigerators for manual temperature recording.

A State-of-the-Art Monitoring System: Assured Compliance

Veriteq uses very low temperature loggers, which operate to -90°C. Commenting on the system, DCR laboratory manager says, “We not only improved the quality and availability of our documentation, but we can now provide a higher level of detail to the FDA and our [client] pharmaceutical companies.”

With the viewLinc Monitoring, Alarming & Reporting system, data from each logger can be viewed from any PC on the network using a standard Internet browser. Monitored sites can be isolated for the user to view only those areas of interest or responsibility. Alarms can be sent to PC, audible alerts, email, text or pager. Alarms that require acknowledgement can be sent to other staff members if no response is seen by the system.

Reports on alarms and data can be generated automatically and sent via email. Reports are secure records with a complete audit trail that meet the most stringent compliance guidelines.

"The Veriteq system is far better than the way we used to do it," said DaVita Clinical's senior lab manager. “The system is so much more accurate — it virtually eliminates the possibility of human errors.”

For more information about DaVita Clinical, visit the DVC website.

To learn more about Veriteq's Monitoring & Alarming systems, call (800)683-8374 or Email a Veriteq Representative.