Validation Compliance Annual: 1995CRC Press, 17 Feb 1995 - 1200 halaman "Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations." |
Istilah dan frasa umum
abbreviated application abbreviated new drug adequate agency and/or antibiotic application or abbreviated appropriate approved audit automated data collection batch batch production biological blood bank blood components blood establishments CBER CE marking CGMP clinical investigation compliance computer system computerized conducted contain copy data collection system determine documentation donor Drug Administration drug application drug product effectiveness electronic signatures ensure equipment evaluation finished device firm Food and Drug functions guidelines hardware identified inspection institutional review board intended investigational new drug issues labeling laboratory licensed listed drug maintained manufacturing practice marketing medical devices ment methods notified body paragraph performed person personnel Plasma Plasmapheresis protocol quality assurance quality system reference regulations regulatory request requirements responsible safety samples specifications sponsor sterile storage submitted Subpart substance test systems tion verify