Data management software systems

…We are writing to you because on February 28 through March 3, 1997, Investigator James E. Moore from the Food and Drug Administration (FDA) collected information that revealed a serious regulatory problem involving the products known as the “_____” and the “_____” data management software systems, which are made and marketed by your firm. Please excuse our delay in corresponding with you.

1. Failure to establish a device master record (21 CFR 820.181). For example, there is no documentation demonstrating the device specifications including the appropriate revisions, programming, finished product testing and software installation of your devices. This would also be a violation of the Quality System Regulation, 21 CFR 820.181.

4. Failure to establish written manufacturing specifications and processing procedures in order to assure that the device conforms to its original design or any approved changes in that design (21 CFR 820.100). For example, there is no documentation demonstrating the validation of software changes. This would also be a violation of the Quality Systems Regulation, 21 CFR 820.70.