K L Keatley
- Controversy over genetically modified organisms: the governing laws and regulationsK L Keatley
Gilead Sciences, 2860 Wilderness Place, Boulder, CO 80301, USA
Qual Assur 8:33-6. 2000..The primary agencies currently regulating biotechnology are the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA)...
- A review of the FDA draft guidance document for software validation: guidance for industryK L Keatley
Colorado Analytical Research and Development Corporation, Colorado Springs 80907, USA
Qual Assur 7:49-55. 1999..fda.gov/cdrh/comps/swareval++ +.html. Presented here is a review of the main features of the FDA document for Quality System Regulation (QSR), and some guidance for its implementation in industry...
- A review of US EPA and FDA requirements for electronic records, electronic signatures, and electronic submissionsK L Keatley
Colorado Analytical Research and Development, an Operating Unit of Pyxant Labs, Inc, Colorado Springs 80907, USA
Qual Assur 7:77-89. 1999..This FDA ruling is discussed below and is available at: www.fda.gov/cder/esig/index.htm...
- A comparison of the U.S. EPA FIFRA GLP standards with the U.S. FDA GLP standards for nonclinical laboratory studiesK L Keatley
Pyxant Labs, Inc, Colorado Springs, USA
Qual Assur 7:147-54. 1999..The GLPs were meant to assure that studies submitted to the agencies for the registration of products for which they were responsible would protect the environment, and, the safety and health of the public...