Zero-defect tolerance
apartis FDA-standard quality
As with medicines and medical devices, all software employed in the medical or pharmaceutical area is subject to the highest safety requirements. apartis takes every step throughout the entire software development process to prevent errors and minimize risks. Needs and feasibility studies before programming begins are conducted as a matter of course. Continuous checks during every phase of the development guarantee maximum quality.
Our products consistently receive top audit and certification ratings and also meet the strict requirements of the American Food & Drug Administration (FDA) in respect of quality and documentation.
Before new software is released it first undergoes stringent tests in our 400mē testing laboratory. This is equipped with a completely independent network environment to exclude any external interference. We verify and validate the results, analyze the risks at all system levels and control the traceability of the processes involved. Tests are performed on actual devices or virtual machines depending upon requirements.
In addition to function tests we also conduct stress and load tests at maximum configuration. These are largely performed automatically with leading off-the-shelf programs and apartis tools. We also employ hybrid technologies, e.g. in the preparation phase, to save time and ensure transparency.