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== High-level overview == Broadly speaking, there are a few categories of work which are regulated in many countries: * Medical devices * Medicinal products (drugs) * Animal studies * Human clinical studies * Laboratory tests There will generally be a relevant local, state, federal, or international authority in charge of establishing regulations and either performing or outsourcing the compliance process. As part of the regulatory process, there are general guidelines that you are expected to follow. These are typically known as some form of "Good X Practice", such as: * Good manufacturing practice * Good clinical practice * Good laboratory practice These typically will resolve down to a set of guidelines regarding expectations for quality management, risk assessment, and other engineering practices. It is common for legislation to prescribe a need to follow relevant GxP and what properties a compliant system should have, but not to describe exactly what such a system will look like. This gives you flexibility in designing the exact processes and infrastructure that you will need. Traceability is a common concept found in many regulations. The general concept here is that a product in the field should be connected to the process used to produce it, including design requirements, vendor management, manufacturing process, shipment, storage, calibration, testing, and so on. In practice this typically means that each product in the field carries a reference number and a lot or serial number, which the vendor can use to identify the relevant records. This enables effective recalls, safety notices, and other processes to occur in a selective fashion, for example by recalling all food produced at a specific facility on specific dates. Without traceability, a recall may shift from a narrow scope to one involving all product at unrelated locations.
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