The FDA recently proposed draft guidance: Computer Software Assurance for Production and Quality System Software. The guidance provides recommendations regarding computer software assurance for computers or automated data processing systems used as part of production or the quality system.
Per 21 CFR 820.70(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.
There is a similar clause in ISO 13485:2016 4.1.6:
the organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated
In the proposed guidance, computer software with intended uses that directly or indirectly support production, or the quality system require validation. With the large number of available Apps that can facilitate internet orders and help you to manage inventory, it should not come as a surprise that many of these Apps (perhaps indirectly used) would require validation (if used at a medical device manufacturer or distributor site).
I encourage medical device manufacturers to make an inventory of all Apps used in the organization and determine if validation is needed.