Incubator Validation孵化器验证
Incubators operate in the range 25°C to 75°C and so TQSoft™ with MadgeTech loggers are ideal for the thermal mapping required for the qualification exercise.
The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically, every 6 months.
TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration checking procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.
Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracks thermocouple and logger usage and allows engineers to set limits.
TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and has been developed and maintained according to GAMP.
Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record…
IQ安装确认、OQ运行确认、PQ性能确认与验证
培养箱的运行温度范围为 25°C 至 75°C，因此带有 MadgeTech 记录仪的 TQSoft™ 非常适合资格测试所需的热图绘制。
用于执行热验证的传感器和数据采集硬件的准确性至关重要。校准和校准检查操作程序对于正常可接受的验证实践是必不可少的，无论使用什么传感器（RTD、热敏电阻或热电偶）。验证报告必须表明热电偶、传感器、校准和数据采集设备已根据可追溯标准定期进行检查。应在验证研究之前和之后检查热电偶。 RTD 和热敏电阻需要的检查频率较低，通常每 6 个月定期检查一次。
TQSoft™ 热验证软件可以通过提供易于操作的自动校准和校准检查程序和报告来帮助实现这些精度。 TQSoft™ 还将所有验证和校准设备详细信息存储在测试设备数据库管理系统中。在验证研究之前，工程师可以勾选正在使用的设备项目，TQSoft™ 将此信息存储在每个验证记录中。这允许用户创建有关校准或验证设备的各个项目的审核报告。
热电偶的使用寿命有限，远程记录器电池电量不足可能会导致验证过程中出现昂贵的问题。 TQSoft™ 热验证软件跟踪热电偶和记录仪的使用情况，并允许工程师设置限制。
TQSoft™ 热验证软件符合 FDA 21CFR 第 11 部分中关于电子签名的规定，并根据 GAMP 进行开发和维护。
在验证研究之前，工程师可以勾选正在使用的设备项目，TQSoft™ 将此信息存储在每个验证记录中……
THP Validator无线温湿度验证仪可以进行QC实验室设备的3Q验证，温湿度均匀性、波动度、温湿度上下偏差热分布验证检测。
欲了解更多信息，请联系我们的产品经理和验证工程师
Tel：021-68902733,18302112429
TQSoft热验证软件在这样的质量管理体系中可以发挥重要作用。
Incubator Validation孵化器验证
