Posts Tagged ‘Regulatory Compliance’

Over the past several weeks, I’ve published a series of posts that talk about how to assess and mitigate risk with your regulated IT systems. The FDA recommends using a risk-based approach to accomplish this feat, and we agree, so we laid out a four-part approach for you: Assess a system for its regulated status […]

A few weeks back, I described how to determine the risk level of a proposed change to a regulated IT system. I also talked about how the system risk level (SRL) and change risk level (CRL) work together to determine the level of rigor required to implement a proposed change without disrupting its validated state. […]

Now that July is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in June – they’re ranked in order of popularity, with number one being the most viewed piece. What Exactly Is An “Adverse […]

This is post #4 in a short series about assessing and mitigating risk with regulated software. Over the past few weeks, I’ve discussed the rationale for taking a risk-based approach to this topic, as well as the first couple of steps to take: determining whether a system is regulated and, if so, determining its risk […]

In the life sciences industry, many of the software systems we use must comply with federal regulations. The purpose of these regulations, such as U.S. FDA 21 CFR Part 11, is to ensure that the data being housed and produced by these software systems is accurate and trustworthy. When the FDA first introduced 21 CFR […]

Governance historically has been instituted to support regulatory and compliance needs as well as requirements from business intelligence and analytics. These are still essential aspects of Governance, but more and more programs are broadening their reach to address operational needs and helping to solve operational business challenges. Governance is therefore starting to focus more and […]

In my previous posts I discussed trends impacting governance. In my next few posts I will cover trends in governance – the first of which is Interest from Leadership. Governance is being discussed in the C-suite as a business imperative to the success and growth of a company. As the “Information as an Asset” takes […]

Big Data brings its own challenges to the governance practice. Governing massive quantities of information that move quickly in and out of the enterprise requires a robust and nimble governance program. Governance practitioners must adjust their thinking and approach to deal with this while still maintaining the integrity and control of the information that is […]

Information Governance is beginning to pop-up and position itself as different – but related – to Data Governance. Generally, the healthcare industry is seeing Information Governance more as a strategic endeavor, while Data Governance is more tactical in nature. However, it really seems to be about providing a more business focus on the governance initiative. […]

Governance in healthcare organizations is undergoing somewhat of a resurgence or rebirth as the industry begins to recognize not only the value of governance, but that it is a critical component of the organization. Forrester Research has labeled this evolution “DG 2.0.” But regardless of the label or the current support (or lack thereof) that […]

If you recall, in my last post I talked about communications and how it is a critical element for a successful program. I mentioned one aspect of that being communicating the benefits and value of the governance artifacts, and to do that requires measurements that help you gauge that success. To measure successfully requires two […]

If you’ve been following along with my blog series, you know that Governance is responsible for setting the framework within which information management decisions are made. This framework is not only clarifying who does what (decision rights, processes, etc.), but also the “bumpers” to keep everything under control (rules, policies, controls, etc.). All of these […]