Archive for the 'Information Technology' Category

Digital Signatures Growing as a Result of Part 11

During the past two years, FDA has been looking more closely at enforcing Part 11 of the Title 21 Code of Federal Regulations regarding electronic records and signatures (see back story). As a result, digital signatures are becoming more commonplace throughout laboratories, manufacturing sites, and offices as companies search for ways to track and file processes, SOPs, approvals, supply chain movement, drug applications, and more. Quality management systems, much like our personal lives, are becoming far more digital and far less paper-based.

PharmTech discusses this issue and related compliance issues in a recent webcast, available on-demand here.

IT and Operational Technology Convergence: Are You Ready?

Gartner has developed a body of research around the convergence of IT and Operational Technology (OT) and the implications for organizations (1). Much of the research speaks to the opportunities and challenges this convergence presents to organizations. By way of definition operational technology, according to Gartner, refers to “physical-equipment-oriented technology” (e.g., manufacturing equipment) that is shifting from proprietary, hardware-based to open, software-based technology. Thus the lines are becoming blurred as to who “owns” and supports the infrastructure, integration, upgrades, security and analyses of OT software systems. Read more »

A New Way to Share Best Practices

Angie Drakulich PharmTech editorEver wish you were a fly on the wall in another laboratory? Well, a new journal website offers the industry opportunities to do just that—to see through video how other scientists carry out particular experiments and processes. Read more »

Merck and Merck Face Off

Stephanie Sutton Pharm Tech EuropeWe love social media here at, but many pharma companies have been wary about how to make the most of these new communication platforms—and understandably so given that last year Novartis received an FDA warning letter about a Facebook widgit on its website.

One pharma company that does seem to love social media though is Germany-based Merck KGaA—so much so that the company was prepared to go to court when its Facebook page was recently taken over by US rival Merck & Co. Read more »

Pharma Scammers A Tweet

Stephanie Sutton Pharm Tech EuropeThe pharma industry has been scratching its head for some time about how best to exploit social media and efforts in this area have been tentative with uncertainty over regulations. Pharmaceutical spammers, on the other hand, have little reason to hold back. Already, spammers are taking advantage of Twitter to promote cheap pharmaceutical products such as Viagra and Levitra. Indeed, a recent study by the University of Akron in the US explained that Twitter “presents a new forum for spammers to facilitate illegal pharmaceutical scams”. Read more »

When Electronics Go Bad

Stephanie Sutton Pharm Tech EuropeThe other day I was editing an interesting piece about e-prescribing in Europe. A lot of processes in both healthcare and the pharma industry, as well as in every other aspect of our lives, are moving to electronic systems and, of course, such systems offer many benefits. Being sceptical, however, I turned to my colleague and asked, “what happens when the system goes wrong?” Because, let’s face it, all electronic systems seem to suffer serious issues at some point. Read more »

RxResponse Monitors Pharma Supply Chain During Disasters

Angie Drakulich PharmTech editorWhen natural disasters such as Hurricane Irene strike, obtaining food, water, and supplies tend to be at the top of at-risk residents’ minds. Having necessary medication—and enough of it—is also crucial. Even before Irene hit the US coast last week, PhRMA issued an alert to the public about documenting existing prescription medications with the RxResponse online medication card tool. Read more »

Google’s Worldwide Woes

Rich WhitworthThe online sale of pharmaceutical products is a big headache for regulators. The Internet is the counterfeiter’s dream market stall, and virtually begs to be abused. Some surveys suggest that more than 60% of drugs purchased online are fake. But governments and regulators are fighting back. In July, the EMA welcomed a new directive on falsified medicines that had a strong focus on the sale of illegal medicinal products on the Internet—somewhat obscurely referred to as “sale at a distance to the public”—and the European Commission was charged with creating a cryptographic logo to identify legal sites.

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Meet the New Drugs: Same as the Old Drugs

Erik Greb PharmTech editorStock prices have fluctuated wildly in response to factors such as persistently high unemployment, impending cuts in federal spending, and the downgrade of America’s credit rating. The already conservative pharmaceutical industry is hunkering down and socking away cash to be safe. Since January, Merck has saved $1 billion in cash, and Johnson & Johnson has saved $3 billion. The savings have come at the expense of R&D budgets, making observers wonder where the new drugs will come from.

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Hackers, Ahoy! Is Pharma Prepared?

Stephanie Sutton Pharm Tech EuropeAs a geek, I’m interested in anything related to computers so throughout June I’ve been following the reports of hack attacks on a number of big names including Sony, Nintendo, the Brazilian government and the US Central Intelligence Agency (CIA). Earlier this week, the news website Information Age also reported that Bayer’s Italian website experienced “illegal interference” by hackers last weekend. At the beginning of June, the UK’s National Health Service (NHS) was also attacked by the hacking group Lulz Security (commonly known as LulzSec). In an email sent on 9 June, LulzSec claimed to have obtained admin passwords from the NHS website. The email also added: “We mean you no harm and only want to help you fix your tech issues.” Read more »

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