FACTA Farmaceutici S.p.A Product: drug manufacturing facility Date:1/13/2017 1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)). For multiple sterile drug product lots, your original data showed failing results, but data you reported showed passing results....Read More

Since being introduced, test automation continues to evolve as new technologies are created and released.  One such evolution is Ranorex Online which has been officially released for public beta testing.  Those familiar with test automation are aware that browser plugins are a necessary evil for any web-based testing framework.  Ranorex Online attempts to eliminate that...Read More

The US FDA issued a FINAL guidance entitled: “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions”. This guidance references software features in Appendix C the device description section. The full guidance is at the link provided. FDA FINAL Guidance Benefit-Risk IDE DevicesRead More