FDA Regulation 21 CFR 820.70(i) in Production and process controls states "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."
Any PC-based technology requires validation. Software validation can take a team weeks to perform. For lean manufacturing practices, can't that time be better spent?
The FDA considers an MES gateway appliance a "black-box" meaning it's dedicated to a specific function thus forgoing software validation yet still meeting the FDA requirements for 21 CFR 820.70(i).
The Data Commander™ MES gateway appliance is closed architecture - dedicated to a specific function, and is considered an off-the-shelf, "black-box" solution to the FDA. Hence, avoiding FDA software validation.
Watch this video to learn how the Data Commander™ can save you time and money. Read more here.