Lumisys 5/12/98 MammoWorks” an interactive database designed for mammography practices and teleradiology devices.
1. Failure to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications [21 CFR 820.70]. For example, your firm does not have sufficient evidence which provides a high degree of assurance that your production process and duplication equipment used to produce your software computer disks for your published products will consistently produce products which meet their pre-determined specifications and quality attributes. Additionally, obsolete manufacturing procedures were disclosed in your disk duplication area.
2. Failure to control procedures for receiving, reviewing, and evaluating complaints [2l CFR 820.l9S]. For example, your firm does not have sufficient evidence which provides a high degree of assurance that the computer software used for monitoring customer complaints and performing other quality system activities will generate and maintain information to properly evaluate customer complaints and contain explanations for reasons not conducting complaint investigations.