The cyber-attack on Anthem, the nation’s second-largest health insurer, directly reflects the vulnerability of healthcare organizations, which are years behind other industries in regards to protecting personal information. In today’s healthcare industry, the federal government encourages sharing information across the continuum, which is critical to improving patient care. The challenge is the balancing act between […]
Regulatory Compliance
2 Questions To Ask When Deciding Whether To Validate Your CTMS
As a company who implements and enhances clinical trial management systems (CTMS), a question we hear a lot is, “Do we need to validate our CTMS?” And, to be honest, it’s one we continue to debate internally. Why is the answer not black and white? Well, our internal debate always works its way back to […]
This Is Bad News For Sponsors And CROs
In a recent post, I wrote how not giving principal investigators (PIs) the right systems (i.e., investigator portals) can lead to frustration, causing them to eventually withdraw from studies. Apparently, times are still rough for PIs and investigator sites. According to a new Tufts CSDD Impact Report and Wall Street Journal article, while the […]
Deflategate: Lessons Learned for Financial Services Firms (and the NFL)
If you had not heard about the latest NFL scandal with the New England Patriots leading up to the biggest football game of the season (the Super Bowl) surely you did during some of the coverage of the game. National news took time out of their normally depressing nightly news to cover the latest developments in Deflategate. I’ll preface […]
21 CFR Part 11 Decoded: Controls For Closed Systems
This post marks the first in the 21 CFR Part 11 series that is focused on Subpart B – Electronic Records. Since Subpart B contains four sections, its “mini-series” will contain four posts. Do you have your decoder rings handy? It’s time to decode Section 11.10 – Controls for Closed Systems. In the table below, […]
Attaching Files To Cases In Argus Safety
Attaching files to a case is an important aspect of case management work processes. Typically one would attach source documents here, such as a discharge summary report, a hospitalization record, patient laboratory records, etc. Without formal integration to a document management system, it’s quite easy to maintain safety source documentation by attaching a file in […]
21 CFR Part 11 Decoded: Definitions
In the previous two posts in this 21 CFR Part 11 Subpart A “mini-series,” we decoded Sections 11.1 – Scope and 11.2 – Implementation. It’s time to wrap up this mini-series with Section 11.3 – Definitions. Make sure no one is looking and then grab your decoder rings! In the table below, the actual language […]
The Next Best Thing To An Argus Safety Demo
Whether you’re using Oracle’s drug safety and pharmacovigilance solution, Argus Safety, a different application from another vendor, or even Excel to capture and manage adverse event data, our January 29th webinar, Features of a World-Class Safety System may be of interest. Dr. Rodney Lemery, the director of Perficient’s life sciences safety and pharmacovigilance division, is […]
Banks Have a Handle on KYC, Lack KYV Guidance
While most banks have a better grip on Know Your Customer requirements than they did years ago, the challenges and risks of non-compliance continue to grow as regulators focus on sources outside the financial institutions’ walls. What is the impact of a failed risk management program as a result of actions committed by a vendor or service provider? Your financial institution may be […]
21 CFR Part 11 Decoded: Implementation
In the first post in this 21 CFR Part 11 Subpart A “mini-series,” we decoded Section 11.1 – Scope. It’s time to grab your decoder rings again while we take a look at the next Section, 11.2 – Implementation. In the table below, the actual language from each regulation is on the left, and my […]
21 CFR Part 11 Decoded: Scope
In the previous post in this series, we explained what the name “21 CFR Part 11” means and how the Code of Federal Regulations (CFR) is organized. In this post, we will actually dive into Part 11 and begin to decode Subpart A – General Provisions. Because Subpart A contains three Sections (Scope, Implementation, and […]
The 21 CFR Part 11 Decoder Ring
If you’re connected to the life sciences industry in one way or another, odds are you’ve heard the term “21 CFR Part 11.” You may have gathered that it’s a set of regulations related to computer systems, but, unless you work in some sort of compliance group, you might not understand what it’s about or […]