DOCUMENT CHANGE PROCEDURE. This procedure first defines the classes of changes; then describes the mechanics of the change process based on those classifications per SeaMED's Internal Quality Assurance requirements. 2.1. Document classifications; Documents may be described as either generic or product-specific. The generic category includes Source and Specification Control Drawings (SCD) used for buying and inspecting commercially available "off-the-shelf" parts. Product-specific documents include all documents that are unique to the design of the product.
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DOCUMENT CHANGE PROCEDURE. This procedure first defines the classes of changes; then describes changes and the mechanics of the change process based on those classifications per SeaMED's Internal internal Quality Assurance requirements.
2.1. 2.1 Document classifications; : Documents may be described as either generic common or product-specific. The generic common category includes Source and Specification Control Drawings (SCD) used for buying and inspecting commercially available available, "off-the-shelf" parts. Product-specific documents include all documents that are unique to the design of the product.
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Sources: Professional Services Agreement (Rita Medical Systems Inc)