21 CFR §820.70(i) (i) Automated processes. When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented. Will this clause be applicable to software tools like Minitab, FEA and Moldflo etc which are used for design analysis and other design needs? I am aware and understand the FDA guidance document on Software Validation , the part which is not clear is the "Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR §820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system." Any clarity or feedback will be much appreciated!