Planmed OY Finland

Planmed OY 5/9/96 Finland

3. Failure to routinely calibrate measurement equipment, to establish adequate calibration procedures, and to maintain records of calibration, including the next calibration date; and failure to validate software programs by adequate and documented testing, when computers are used as part of an automated production or quality assurance system, as required by 21 CFR 820.61. For example:
a. The [purged text] used in the Incoming Inspection Area was found marked for recalibration on “12-95”, one week overdue.

Your response appears to be adequate in that you indicated that the [purged text] has now been calibrated. The reason for the overdue has been analyzed and found to be human error. The calibration system has been audited internally by R&D. The situation for corrective actions issued by the quality department to the R&D director is enclosed (translation and a copy from the original). The adequacy of your response will be confirmed during the next inspection of your facility.
b. The complex software-driven devices lack emulation tools for software validation.

In response to this deficiency, you stated that the management review carried out after the FDA inspection of the software development, authorized management to implement a software validation method based on emulation model. The model shall be implemented in the ongoing Intra oral x-ray project. The adequacy of your response will be confirmed during the next inspection of your facility.

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  • Regulatory submission pre-review
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  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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