Regulatory Compliance

Perspectives on topics that impact regulatory compliance

Regulatory Compliance Hero

Financial Statements and Disclosures under CECL

Entities must first include the new CECL disclosures in their financial statements and regulatory reports (e.g., the quarterly call report), commencing with the aforementioned effective dates. There is no separate filing requirement for CECL. The structure and granularity of an entity’s income statement and balance sheet does not to change, as the details of the […]

What Remote Sellers Should Know About South Dakota v. Wayfair, Inc.

Editor’s Note: This guest blog post comes courtesy of Gail Cole with Avalara. The U.S. Supreme Court’s decision in South Dakota v. Wayfair, Inc. is a game changer for online sellers and other businesses that sell across state lines. A state can only tax a business that has nexus, a significant connection to the state. For decades, nexus […]

CECL Model Alternatives

CECL requires loss estimates to include relevant information about past events, current condition and reasonable and supportable forecasts using both internal and external information, including a range of qualitative and quantitative factors. Estimates of expected credit losses must consider information related to the borrower’s creditworthiness, the issuer’s underwriting practices, and the current and forecasted direction […]

The New CECL Accounting Standard

CECL, or current expected credit loss, is a new accounting standard that will change how financial institutions account for expected credit losses. Complying with the new CECL standard will have a major impact on an institutions’ operations, accounting/finance, IT, credit, and risk processes and systems. Under current US GAAP (generally accepted accounting principles), an “incurred […]

Key Takeaways About Compliant IT Systems In The Cloud

This is the final post in our series on maintaining regulatory-compliant IT systems in the cloud. In this post, we’ll go over the key takeaways from the series and then we’ll send you on your way! Regardless of how much control you have over your IT systems, if you are using them for regulatory purposes, […]

Tips And Best Practices For Compliance In The Cloud

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 […]

How To Use Contracts For Regulatory Compliance Of Cloud Systems

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 […]

Oracle

Argus Safety, Oracle Clinical & RDC Release Notes [July 2018]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, including: Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Generally speaking, we review release notes at the beginning of each month for the previous month. On occasion, there are no new releases and, therefore, nothing to […]

How To Qualify Cloud Vendors

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 […]

Who Is Responsible For The Compliance Of Cloud Systems?

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 […]

3 Steps to Overcoming Communication Barriers

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 […]

Cloud-Hosted Terminology: Types Of Systems

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, […]

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