Is Dracal Technologies suitable for GMP/GLP environments with user-accessible calibration logs?

Dracal instruments are used in regulated settings such as medical device manufacturing and ISO 8655 compliant labs. Here is what they bring to a GMP or GLP environment:

• ISO/IEC 17025 traceable calibration certificates, ordered with the instrument or later (see the steps)
• A transparent user calibration (-CAL option): the correction points are stored in the instrument, can be disabled at any time, and the uncorrected values remain available in parallel (see how)
• Logs recorded on a SensGate that can be exported as binary files that can't be edited

Note that the instrument keeps only the adjustment points, with no calibration date or history (calibration FAQ). Your calibration records therefore stay in your quality system.

That said, the validation of your computerized system, electronic signatures and audit trail remains your responsibility, as with any instrument. Our sensors integrate easily into the validated software you already use, through our integration tools. On request, we quickly provide any additional documentation you need for your validation file. Tell us about your requirements and we will help you check the fit: contact us.