Company: Zeus Scientific Inc.Date: 3/27/01 Product: IVD test kits In addition to the above,your firm failed to validate the electronic documentation system used to record corrective action requests (CARs) prior to implementation. The electronic record requires electronic signature,for which there is no timestamp on the record. Also, you failed to certify to the FDA that...Read More
FDA and 62304 Training – Boston – June 4-6, 2019
3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well. John F. Murray, Jr., will be among the faculty!