Posts Tagged ‘compliance’

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 […]

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, […]

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 […]

Exchange hybrid environment users rejoice! Microsoft Teams now supports eDiscovery, Compliance Content Search, Review and Export for Teams users with your setup! In this article I will discuss: How this setup works Why Microsoft has chosen to support this How you can get enabled if you fit into this group How the heck does this […]

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. […]

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. […]

The benefits of cloud hosting – including Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and Software-as-a-Service (SaaS) – are very clear: less upfront capital, faster implementations, scalability and elasticity, and no need for individual companies to maintain physical space, hardware, and/or technical staff for support. But there are also several risks to consider, including physical and technical security, […]

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 foundational work companies should have already completed. By now, you should have a program in place that covers the following work streams: Engage Report Filing […]

In our new guide, we discuss the background of the SEC’s Investment Company Reporting Modernization Rules and the potential effects on individual financial institutions. While you can check out the full guide here, the snippet below shares some of deadlines that the new rules present. Form N-PORT If you are a larger entity with net […]

The strategic vision of the manufacturing and automotive treasury function is to deliver efficiency, control, and scalability. The logical structure for this transformation includes several key components: business events, centralized demand deposit accounts with banking connectivity, and a reporting data warehouse. A comprehensive finance and treasury transformation program can help improve cash and liquidity management, […]

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 shares the rules’ objectives and expectations. The SEC wants to improve: The quality of information that funds report to the Commission The Commission’s risk monitoring and oversight, examination, […]