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FDA Cybersecurity Guidance For Medical Devices

In January 2016, the U.S. Food and Drug Administration (FDA) published a guidance draft that includes important steps that should be taken by medical device manufacturers in order to frequently address cybersecurity risks.
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Common Compliance Mistakes

Compliance management is a vital process within the pharmaceutical and life science industries. Here are some examples of common compliance mistakes in the pharmaceutical and life science industries.
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Medical Device Packaging Growth

The Medical Device Packaging market is expected to grow 5.92% over 2013-2019. What does this mean for different industries/products?
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How to Use the FDA UDI Database

The FDA launched the Global Unique Device Identification Database which provides a resource to report adverse effects of devices and hasten reactions to recalls. What does this mean and how is it used?
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Software Testing and Quality Assurance Emphasis in New Areas

One of the top priorities of any corporate IT organization is always software testing and quality assurance. Shipping a product is one thing – making sure that it is free from bugs and other issues that could negatively affect the end user experience is something else altogether.
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SAP Partners with Birst Inc.

SAP, the European software giant, announced on October 9, 2014 its intention to team up with Birst, a cloud service provider for businesses intelligence (BI.) The goal of this partnership is to provide customers instant computer data, stored in the cloud via SAP's HANA cloud platform.
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SAP SE Acquires Concur Technologies

SAP SE, the German enterprise software vendor, made the news on September 18th after they announced their plans to acquire Concur Technologies for a price tag of $8.3 billion, making this the biggest purchase SAP has ever made. Concur Technologies is considered a leading provider of expenses management and cloud-based travel solutions.
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Oracle’s BlueKai Acquisition: What It Means

On July 22, 2014 Oracle announced their new Oracle Data Cloud service. The most significant piece of this service came with their February 2014 acquisition of BlueKai for between $350 and $400 million.
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Building an Effective Compliance Strategy

Running a business entails handling everything from developing products, creating sales strategies, employee training and handling customer/client service requests. Because there are so many things on which to focus, some businesses overlook the need for an effective compliance strategy.
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Third Party Logistics (3PL) Providers: What You Need to Know

Pharmaceutical companies rely heavily on third party logistics providers as critical components of their supply chain. With the pharmaceutical industry being one of the most strictly regulated industries globally, 3PL providers must adhere to applicable guidelines established by government and state agencies to ensure pharmaceutical manufacturers that they are in compliance with these regulations.
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Drug Supply Chain Security Act: Title II

In order to maintain the U.S. drug supply chain as the world's safest, Congress enacted the Drug Supply Chain and Security Act (DSCSA) in 2013. The Act has specific requirements to prevent threats to the supply chain and maintain the integrity of drugs that are distributed within the U.S.
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