Posts Tagged ‘technology’

As we’ve learned in the previous posts in this series, having a thoughtful, thorough cloud vendor qualification process and intelligent SLAs in your cloud vendor contracts will help you maximize the value of the cloud while maintaining regulatory compliance. In addition, here are some tips and best practices to help you knock it out of […]

In my previous post in this series, we discussed how to qualify cloud vendors. Once that process is complete, the second step to maintaining compliance is to document your specific regulatory requirements in a contract with the cloud vendor, usually in the form of service-level agreements (SLAs). In this blog post, I include a range […]

We recently completed a 21 CFR Part 11 gap analysis engagement for a client that was largely using SaaS applications, but had no cloud vendor qualification process in place. They had just been allowing each business unit to select the applications that met its user requirements, accept whatever validation documentation the cloud vendor supplied (if […]

Any time you take advantage of a cloud service – infrastructure, platform, or software – for a regulated purpose, you are ultimately responsible for its regulatory compliance, not the cloud vendor. This is critical for you to remember. So, how can you ensure regulatory compliance of a software system you did not build, you do […]

We often hear the phrase “Seek first to understand and then to be understood” or are told to actively listen. While these are important, often time it’s simply not tactical enough. Too often what we hear is skewed by the filters that we (and our audiences) apply. So how do we ensure what we say […]

As we continue our series on maintaining regulatory-compliant cloud systems, let’s touch on a few key terms. Below are explanations of the primary cloud-hosted offerings available in the market. Infrastructure-as-a-Service (IaaS) When you purchase a software system and opt to have a vendor host it for you instead of installing it on servers you own, […]

Recent months have seen many discussions and questions about tax reform and its impact on the industry as a whole. The introduction of lower corporate tax rates in the U.S. has created a jubilant atmosphere, as the rates are generally expected to boost earnings and investments for many insurers. Companies including Aflac, MetLife, Travelers, and […]

If your company makes drugs, medical devices, or biologics (vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins), it is regulated. If your company is regulated, then every IT system you use to design, develop, conduct trials, manufacture, package, label, store, distribute, install, or service your products is also […]

Although investing in technology plays a big role in digital transformation, transforming or growing a car rental company isn’t just about the deployment and modernization of front- and back-end systems. Transformation initiatives also require the development, implementation, and execution of strategies and programs capable of delivering operational efficiency, reducing expenses, and increasing revenue. For example, […]

The first thing any investment company must do in response to the new SEC Investment Company Reporting Modernization is evaluate its current state of readiness. Chances are you have started a compliance program. However, we can help you understand your gaps, including areas where you need immediate action and longer-term changes to support the program. […]

Ensuring that agents and brokers have the best tools to evaluate and close opportunities can be a real differentiator for insurance companies. For example, many companies wish to invest in solutions that effectively automate and improve underwriting, as such solutions can help remove human bias, increase the lendable pool of consumers, and reduce response times. […]

In a new guide, we discuss the background of the SEC’s Investment Company Reporting Modernization Rules and the potential effects on individual financial institutions. The snippet below talks about the challenges you can expect when developing a response program. Expect challenges in various areas: Data Availability: All required data elements may not be available internally. […]