可靠的环境监测系统满足临床试验赞助商和保障措施的生命增强研究
Founded in 1976, Associated Gastroenterology Medical Group (AGMG) in Anaheim, California and its research affiliate, Anaheim Clinical Trials (ACT), have conducted clinical research trials in all fields of medicine. Sponsored by pharmaceutical and biotechnology manufacturers around the globe, ACT develops new treatments for various gastroenterological diseases and conditions, conducting over a hundred clinical trials per year. The AGMG/ACT team, including doctors, researchers, nurses and staff, proudly provide cutting-edge treatment to patients at no cost in a state-of-the-art facility equipped with the finest available endoscopic equipment and staffed by expert personnel. The center is one of the few GI research and treatment centers in the nation to have a full-time anesthesiologist.
赞助该研究中心进行的制造商不断监视设施，过程以及遵守FDA/EMA和其他严格的法规。该中心每月从赞助商公司监视器进行五到15次访问，他们审核了GXP合规性的所有方面。在这些访问期间，监视器要求温度记录以确保所有冷藏和冷冻药物和样品都保持在规格中。此外，还必须证明对受控环境的环境条件进行了连续监测，以达到适当的温度和湿度水平。
| Challenge | Solution |
|---|---|
这家临床试验公司需要一个监视系统，该系统通过多种可选的方法向负责人员发送警报：电子邮件，PCDISPLAY，本地设备显示，SMS/TEXT和手机消息传递。 |
可以将VAISALA连续监视软件ViewLinc配置为通过多种方法发送警报。借助用于远程监视，报告和警报管理的移动优化界面，用户可以快速确定警报来自何处并通过智能手机确认警报。 |
监视系统仪器需要具有校准证书的可追溯校准，以表明设备的准确性和最后校准日期。 |
The accuracy of each sensing device is assured with NIST-traceable, multipoint calibration. Vaisala calibrates devices in its own Calibration Laboratories accredited by A2LA to ISO/IEC 17025:2005 and ANSI/NCSL Z540-1-1994 standards. |
他们需要一个基于网络的监控系统，该系统可以由负责指定区域的多个用户在线访问。 |
The monitoring system uses existing networks via standard protocols. Device connectivity options include Wi-Fi, Power-Over-Ethernet, Ethernet, direct to PC via USB, or a combination of all. Users log into the system via Web browser to manage their areas of responsibility. |
The records created by the monitoring system software must aid in compliance with 21 CFR Part 11, indicating an unbroken Audit Trail with gap-free records. To ensure this, the system requires redundant recording to ensure against data loss in case of power outage and network downtime. |
ViewLincreports assure compliance with the quality requirements of client- companies who comply with the regulations of global organizations including FDA, SFDA, EMA, etc. No time- consuming configuration is required to create secure, tamper-proof reports with a complete history. Detailed and summary reports include values, locations, duration, acknowledgements and corrective actions along with detailed descriptions of monitored locations. |
挑战：
该设施有失去关键温度数据来监视设备故障或丢失记录的风险。如果录制设备在停电期间损失了电源，或者电池电量损失，则该设备中的数据将永远丢失。环境数据不仅必须完整并且没有空白，而且当前的良好制造实践（CGMP）要求数据准确。此外，根据FDA联邦法规第21条的规定，用于测量和记录受控区域中参数的传感设备必须定期校准，并随附可以进行检查的随附文件。
信息系统总监Jonathan Olesh的任务是寻找一种新的解决方案来监视设施的受控区域，包括实验室，冰柜，冰箱，药房和存储区。新的解决方案将不得不解决该设施现有监测系统缺乏集中化的问题，这使数据获取和报告时间耗尽且困难。Olesh在旧的监测系统中说：“它效率低下，并不像我们临床试验的赞助商所要求的那样准确。
We had sensing devices, both with probes and for ambient monitoring, and they measured and recorded the parameters. However, they couldn’t tell us if the environment was out of range for a particular application. We needed a full-time monitoring system that could alert us if a chamber or room was going out of specification.”
解决方案：
The facility installed the Vaisala Continuous Monitoring System, comprising viewLinc software and multiple kinds of sensors for all monitored environments. Olesh says that since the system was installed, the two top benefits have been the easy, pre-configured reports and the redundant data recording. The reports are easy to generate, audit-ready, and have satisfied the monitors who’ve visited since the system was deployed. The triple-redundant recording ensures that records are always complete; recorded data is saved
- 在测量点（在每个设备中），
- 在主机服务器上，以及
- 通过自动数据传输。
但是，安装Vaisala监控系统还有另一个意外的好处。“我们了解到，我们的一些冰柜要么不准确，要么接近灾难性的失败，” Olesh说。
“在部署了ViewLinc之后，我们注意到冰箱内置显示器的读数已下降了几个学位。来自Vaisala传感器的读数清楚地表明，其中一个冰柜需要维修。我们重新校准了需要它的冰柜监视器，并在完全失效之前修复了冷冻冷凝器。”保守地估计，一项临床研究价值超过一百万美元。对设备故障的这种先发制人的识别可能会节省超过100,000.00美元的研究投资。
在选择新的监视系统时，Olesh评估了几家供应商。首先，该设施的现有系统具有更准确，价格更高的版本。但是，升级的系统仍将需要一个耗时的过程，以收集，分析和配置数据为满足赞助商的报告。评估的另一个系统没有用户友好的界面，根据Olesh的说法，看上去让人联想到DOS。它还需要安装专用网络和大型壁挂式显示器。Olesh说：“我们选择了Vaisala监视系统，因为ViewLinc软件更现代，设计得更好。我们想要一个直观的界面，基于Web的访问，通过文本和拨号来警报以及点击和打印报告。”
自从安装Vaisala系统以来，Olesh指出，实验室工作人员和负责向赞助商提供温度记录的人员已经从对报告和设备校准的质疑到根本没有问题。Olesh说：“现在，我们只是向监视器提供了ViewLinc的校准证书和印刷报告。”“他们一直满意。”