Start Validating application design against specifications

Validating application design against specifications

This paper introduces these new controls and discusses tips and tricks on working with them in practical scenarios.

(1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. We will see concrete examples of these through this document.

" On the other hand, software validation is: "Was X what we should have built? " Building the right product implies creating a Requirements Specification that contains the needs and goals of the stakeholders of the software product.

If such artifact is incomplete or wrong, the developers will not be able to build the product the stakeholders want.

21 CFR Part 11 regulates the storing and integrity of electronic records in a medical or pharmaceutical test or manufacturing system. 21 CFR Part 820 regulates the quality control systems that must be in place during the design, manufacture, packaging, labeling, storage, installation, and servicing of all medical devices. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process.