Have questions about how GLPs apply to laboratory systems?  Review Erik Staley's presentation, "GLP Compliance: Practical Applications in Digital Pathology," for solutions that were developed for Aperio's ScanScope and Spectrum Plus laboratory systems.

Did you know that the 2009 economic stimulus bill includes significant changes to the Privacy and Security Rules of HIPAA? Among the new changes in the law are that Business Associates are now considered "covered entities," there are new notification requirements for security breaches, civil penalties have increased, and states' attorneys general may prosecute HIPAA violations.  See Subtitle D - Privacy within the "HITECH Act" beginning on page 258, deep within the text of the new law.  There are also new encryption requirements: see an excellent overview in this article.

The 21 CFR Part 11 Yahoo Group goes beyond ERES discussions, and its forum contains highly informative (and often lively) debate regarding current computer system validation practices, regulatory trends, and current compliance topics.

..

Home | Contact Us | Site Map