FDA WARNING_LETTER - Soft Computer Consultants, Inc. - January 15, 2015

On April 30, 2015, the FDA issued a Warning Letter to Soft Computer Consultants, Inc. following an inspection from January 5-15, 2015, in Clearwater, FL. The inspection determined that the firm manufactures Class I/II software systems, which are considered devices under the Federal Food, Drug, and Cosmetic Act. These devices were found to be adulterated because their manufacturing, packing, storage, or installation methods and controls did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to adequately establish CAPA procedures (21 CFR 820.100(a))**: Product Change Controls (PCCs) for software defects did not consistently investigate causes, identify actions to prevent recurrence, or include analysis for similar failure modes in other products. Software testing for corrective actions was not always added to the test repository. The firm also failed to analyze all sources of quality data, such as not conducting trend analysis of complaint data since December 31, 2012, and not timely reviewing/approving existing reports. A field correction's hot fix was not validated for distribution. 2. **Failure to ensure purchased products/services conform to requirements (21 CFR 820.50)**: Quality contracts with design contractors lacked