Regulatory Affairs

You are investigating and certifying quality issues in laboratories. You expect hard evidence from the audited laboratory, because they have to comply with certain regulations, like GMP, GLP, ISO, FDA and others. DRIFTCON has been designed in such a way that you can design or even advice in the regulatory requirements for thermal cyclers, and the used PCR applications in a lab or department. You as an inspector should have access to DRIFTCON at the administrator level. DRIFTCON allows the administrator full access to the user management system, overall system settings and device management. Besides that, the inspector has full access to the trace ability and report options in the software. The software and hardware are compliant to FDA regulations.

Using the report button can access drift of temperature and uniformity. All tested temperatures and times can be displayed and printed. Generally, we recommend targeting the higher temperatures (90 and 95°C), and to different time points and scales.

The thresholds displayed are the thresholds that where used during the actual measurements. Changes in thresholds are displayed in the report.

Threshold settings are used to compare the temperature performance of the cycler against (pre) defined thresholds. These threshold settings might be required by the regulatory body that you represent.

Although the application thresholds are much more difficult and time consuming to design, they are superior to instrument thresholds. In other words: one is comparing if the cycler used to run an application is suitable for this application. If an end user is using a commercialised (diagnostic) kit (PCR, LCR, Real-Time PCR, RT-PCR etc) he or she may request the temperature profile thresholds from the kit manufacturer. Different protocols for the same kit can be advised, depending on the dynamic temperature performance (DRIFTCON driven) of the customers’ cycler. If the kit manufacturer does not have these thresholds available consider using and participating our discussion forum at the specific DRIFTCON website: www.driftcon.com or (if available) join one of the application (your application) threshold setting group.

Instruments thresholds settings (for a specific instrument and block type) are provided with the purchase of a DRIFTCON system. Other individual specific threshold settings may be purchased as software “ad on” (option). The provided specific instruments thresholds are extracted from the global database, which contains measurements from the same brand and type of machine. The provided threshold values are mean values plus or minus 2 x the standard deviation of the values (equals 95% of the population).