Security Standards White Papers
Tripwire and 21 CFR Part 11: Ensuring Integrity and Trustworthiness of Electronic Clinical Data
Overview The U.S. Food and Drug Administration (FDA) has issued a set of regulations, collectively called 21 CFR Part 111 and commonly referred to as Part 11, that provide criteria for acceptance of electronic records and electronic signatures as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology, compatible with the FDA's responsibility to promote and protect public health. Though electronic submissions are currently optional, the FDA is paving the way, with Part 11, for routine and eventually mandatory submission of clinical trial records electronically.
| Publisher | Tripwire | File Format | |
|---|---|---|---|
| Date Published | September 2008 | ||
| Format | White Papers | ||
| Topics | |||
-
Did you find this white paper useful?
White Paper RSSMessageLabs - The Dark Art of Spam
DownloadQuite simply, MessageLabs anti-spam solution provides businesses with the quality of protection they urgently need if they are to stay a step ahead of the spammers - and the increasingly...
Maximising site vistors trust using extended validation SSL
Web business faces a crisis in confidence. Trust in site security is decling, resulting in consumers scaling back on web transactions or just opting out altogether. This white paper address...
Compliance with Data Handling Procedures in UK Government
The UK Data Handling Procedures in Government Report set out clear and mandatory procedures to be followed by all government employees that have access to and responsibility for citizen data....
"We Have Met the Enemy, and He is Us."
Organisations are being force towards indentity- based acess lifecycle management tools in order to support IT agility & flexability, safeley empowering staff and rapid evolution of data cetres and core...
Digital Video Surveillance: enhancing physical security with analytic capabilities
over the past decade, survallience technology has matured dramatically. This white paper looks at soultions for an organisations video survillance needs.
