Keeping FDA Submissions Secure

I was recently talking to a customer about preparing drug submissions for approval by the US Food and Drug Administration (FDA). The process is governed by Title 21 CFR Part 11 of the Code of Federal Regulations that deals with guidelines on electronic records and signatures. Part 11 or 21CFR11, as it is sometimes called, defines criteria to determine if electronic records and signatures are trustworthy and reliable. The customer’s concern was making sure...

I was recently talking to a customer about preparing drug submissions for approval by the US Food and Drug Administration (FDA). The process is...

Do you ever wonder what would happen if a confidential document got into the wrong hands? Yesterday a mistake in delivering a document became a $26 billion problem for Google. R.R. Donnelley accidentally disclosed Google’s quarterly financial statements earlier than the company had intended. It caused Google’s stock price to drop 10% cutting $26 billion from its market capitalization. Donnelley is best known as a provider of printing services, but it’s also the top...

Do you ever wonder what would happen if a confidential document got into the wrong hands? Yesterday a mistake in delivering a document became...

Property comes in in two forms: tangible and intangible. Most of us understand that tangible property is something real and physical, like a car or a computer. Intangible property describes something you can own and can transfer that ownership to another person or corporation, but has no physical substance. An example is a copyright. Intellectual property (IP) refers to creations of the mind for which exclusive rights are recognized in law. Under IP law,...

Property comes in in two forms: tangible and intangible. Most of us understand that tangible property is something real and physical, like a car...

We are more connected to people around the world than ever before. Many of us depend on the Internet in our daily lives, from shopping at home, to paying bills, banking on our mobile devices to sharing information with friends and business partners across the globe. Our growing reliance on technology reminds us that our digital infrastructure is not just a convenience, but a necessity. Can you imagine your life without the Internet? The...

We are more connected to people around the world than ever before. Many of us depend on the Internet in our daily lives, from...

There is a small revolution going on in the printer world. It’s not the traditional world of putting ink or toner onto a piece of paper, but the ability to create a three-dimensional object. We’ve seen replicators in science fiction stories for decades, but now science fact has almost caught up to fiction. 3D printers work like an ink printer. Rather than using ink, they typically use a type of polymer. They spray a...

There is a small revolution going on in the printer world. It’s not the traditional world of putting ink or toner onto a piece...

Many organizations are thinking about document security and how to classify their documents. If you work in a government office, you might have categories like Classified and Top Secret for both paper and electronic documents. If you provide products and services to government or military customers, you may categorize your internal documents with similar designations. Some organizations think about document classification the way they think about access control to computer systems and files. If...

Many organizations are thinking about document security and how to classify their documents. If you work in a government office, you might have categories...

There has been a lot of press and concern over the last few years about moving corporate data to the cloud and maintaining security. A recent article by CIO discusses a variety of things to look for and ways to address some of the concerns. Some organizations stay away from public cloud technologies altogether because they assume nothing is safe. They use virtualization and automatic provisioning internally, so they have trust of the technology inside...

There has been a lot of press and concern over the last few years about moving corporate data to the cloud and maintaining security....

US federal privacy laws don’t adequately protect sensitive information and need updating to keep pace with technology, according to the Government Accountability Office (GAO). Recently congressional hearings were held to help Congress understand the inadequacies of current federal legislation around privacy and security of personal information held by the government. Federal agency collection or use of personal information is governed primarily by two laws: the Privacy Act of 1974 and the privacy provisions of...

US federal privacy laws don’t adequately protect sensitive information and need updating to keep pace with technology, according to the Government Accountability Office (GAO). ...

The days of sitting in your office and working on a desktop computer are long gone. The laptop has become the computing tool of choice for most people, but now smartphones and tablets are augmenting or replacing it as business is done from anywhere, at anytime. Mobile devices and cloud computing are fueling our ability to get work done wherever we are. There is freedom in sharing documents across your many devices by tapping...

The days of sitting in your office and working on a desktop computer are long gone. The laptop has become the computing tool of...

It seems that experiencing a data breach is no longer a matter of “if” but “when”. According to the US Government Accountability Office, there were about 13,000 federal data breach incidents in 2010. In 2011, it rose to 15,500 — an increase of 19 percent. The amount of personal information compromised through data breaches was on the rise in 2011. According to the Privacy Rights Clearinghouse, about 30 million records were compromised in 2011...

It seems that experiencing a data breach is no longer a matter of “if” but “when”. According to the US Government Accountability Office, there...

AI Data Infrastructure