Posts Tagged ‘Regulatory’

Aggregate report preparation represents one of the single most time- and resource-intensive pharmacovigilance regulatory requirements, which is why many companies are interested in more automated solutions that are fit-for-purpose. What we typically recommend to clients is a focused approach that optimizes as much as their internal workflow as possible. We also recommend that subject matter […]

In the recent “Shaping Digital Finance” session at the 20th Milken Institute Global Conference, Corrie Elston, chief technology officer, financial services, Google Cloud Platform, said that a financial services institution may experience 80% accuracy in detecting fraud and 99.5% false positives. As mentioned earlier, only about half of money laundering or terrorist financing incidents were […]

One of the buzzwords in the financial services industry is “machine learning.” While even among experts in the field there is no single accepted definition of machine learning, in simplest terms, machine learning focuses on the use of technology (often referred to as artificial intelligence or cognitive computing), to find solutions through continuous learning. It’s […]

While anti-money laundering (AML) programs may present the biggest opportunity for machine learning to thrive, there are many issues when it comes to fighting money laundering. The number and high caliber of resources required to battle fraud in today’s highly regulated environment are immense, and the cost – of both personnel and technology required to […]

According to the U.S. Department of the Treasury’s Financial Crimes Enforcement Network (FinCEN), “Money laundering is the process of making illegally gained proceeds (i.e., ‘dirty money’) appear legal (i.e., ‘clean’). Typically, it involves three steps: placement, layering and integration. First, the illegitimate funds are furtively introduced into the legitimate financial system. Then, the money is […]

Wealth management firms that have embraced a comprehensive business intelligence (BI) program can: mitigate operational and regulatory challenges across the firm; gain visibility into investment analytics, client relationship management, performance reporting, compliance, and contact management; and generate more comprehensive management and client reports. On the other hand, wealth management firms with a more limited set […]

Routine internal and independent audits can provide insight into sales trends and unusual activity, ensure that the right risk management checks are in place, and provide an opportunity for process improvement. Internal teams can be comprised of individuals from various committees in the company, such as regulatory and compliance, corporate responsibility, employee relations, human resources, […]

Properly trained employees can help keep companies regulatory-compliant, increase sales, and gain the trust of customers and prospects. Financial services companies should have established standard operating procedures and training materials for all levels of employees, with oversight by managers. These training materials should stress the importance of ethical practices and provide employees with clear details […]

While modifying sales goals can be a good place to start, artificial intelligence and intelligent machines (along with a comprehensive process) can be leveraged to analyze data and identify patterns. Aside from knowing the real identity of customers, companies are obligated to ensure that their customers have willingly opted to do business with them through […]

A couple weeks back, I launched a brief blog series about assessing and mitigating risk with regulated IT systems. This week’s post will cover the first part in a four-part approach you can use to do just that: assess and mitigate risk. Part One: System Regulated Status The first step is to determine whether a […]

One of the key issues and perspectives we outlined in our recent State of the Life Sciences Industry guide was President Trump’s intention to reform the Food and Drug Administration (FDA) through the elimination or significant modification of regulations. Part of his recipe for reforming the FDA included bringing in a new head of the […]

If that title compelled you to open this post, then you know what 21 CFR Part 11 is, and you also know – as my 12-year-old step daughter would say – “the struggle is real.” 21 CFR Part 11 is perhaps the most famous (or infamous!) regulation published by the U.S. Food and Drug Administration […]