Posts Tagged ‘compliance’

  While some of you might be hoping that RBM is just a trendy idea that we’ll soon forget, I have to say that when regulatory agencies take the time to draft and produce guidance documents on the topic… 

  When we think of compliance, we think of consistency. Compliance depends on following the same processes and procedures over and over, across the board. After all, that’s why we have all of those SOPs, right? When we’re used to conceptualizing compliance this way, the notion of risk-based monitoring can certainly lead to cognitive dissonance. […]

  Efficiency and compliance are two critical components in highly-regulated industries, especially when it comes to developing drugs and medical devices. Unfortunately, though, these are two areas in which many life sciences companies struggle and could significantly improve through IT solutions. 

There was a lot to talk about in 2015, but our most popular posts centered around compliance, security and risk management. Here are your favorite posts of the year:   Ten | How to drive the most value from your compliance investments Compliance is a strategic imperative for financial services organizations. This post discussed how […]

ThinkAdvisor recently published a list of the top 5 compliance headaches faced by advisors and BDs. Mandatory Succession Planning Rules for RIAs, which could require advisors to “plan for market stress and other events that may prevent an advisor from serving its clients.” These new rules are expected by the end of 2015. Form ADV – […]

The SEC’s Office of Compliance Inspections and Examinations (OCIE) is responsible for protecting retail investors and assessing market-wide risks, but now is shifting its attention also toward figuring out how to leverage data analytics to identify potential for illegal trading activities, conflicts of interest or other misconduct, according to a recent article by ThinkAdvisor, Compliance Data Analytics: Do […]

A recent survey of asset managers, broker/dealers, alternative managers and wealth managers found that compliance is now a core business practice of financial services firms, yet many are not yet devoting the financial resources toward making these programs truly effective. Firms have been facing enhanced scrutiny for years: 81% of respondents stated that they are […]

  In case you missed the headlines in the last few days, the FDA issued a Warning Letter to Duchesnay over Kim Kardashian’s Instagram post promoting Diclegis, the pharmaceutical company’s drug for “the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management,” commonly known as morning sickness. 

For those who would like to take advantage of HDInsight — Microsoft’s Azure-based Hadoop service — but have had concerns regarding compliance and security, this news is for you. HDInsight is now part of Microsoft’s Azure compliance BAA for HIPAA.  In fact, Azure as a whole — including Storage and Azure SQL services — are now […]

  Wow, it’s not often you hear about executives from life sciences companies getting jail time. But in the case of the former CEO of OtisMed, that’s just what he got: two years and a small fine. The company also agreed to pay more than $80 million to resolve other charges. Without receiving FDA approval, […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: The Scope section requires access to electronic records and signatures (ER/ES) at all times. What if the electronic system used by a […]

Compliance has become a strategic and executive-level imperative for financial services organizations. Capturing data to meet regulatory requirements in reporting, risk management, and compliance is timely, expensive and challenging because it requires gathering, enhancing, and reporting the required data from multiple data sources. Thomson Reuters’ sixth annual “Cost of Compliance” study was just released this past […]