Unimark Remedies LtdProduct: active pharmaceutical ingredients Date: 9/28/2015 Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. Your laboratory systems lacked access controls to prevent raw data from being deleted or altered. For example: a. During the inspection, we noted that you had no unique...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.