Here is the FDA website for part 11 issues. Make sure you have plenty of coffee......it is not too exciting, and it is also somewhat vague in parts. Good Luck. http://www.fda.gov/cder/guidance/5667fnl.htm Michael Safron A.S.,HT(ASCP) Manager, Histology WIL Research Laboratories LLC 419-289-8700 ext: 3040 Ashland, Ohio 44805