In Argus Safety, all of the parameters for configuring the worldwide regulatory reporting rules are clearly identified on a single administration screen. You have the capability of selecting various case or event-level attributes, as well as using very advanced conditions, to focus the automated triggering of these report rules in various circumstances.
Regulatory Compliance
21 CFR Part 11: There’s Still Time To Get Your Decoder Ring
Inspired by our blog series from earlier this year, the head of our Computer System Validation team will be delivering a webinar on Thursday, April 23, 2015 aimed at “decoding” the 21 CFR Part 11 regulation. In the webinar, validation guru Sally Miranker will be reviewing the regulation point by point, offering up Perficient’s interpretation […]
SIFMA AML Highlights: Compliance, Enforcement and Preparing for Tomorrow
We attended SIFMA’s Anti-Money Laundering & Financial Crimes Conference last month where experts in the industry discussed legal and regulatory developments, enforcements, and industry perspectives. There were many discussions around whistleblowers, anti-bribery & corruption, securities fraud and even marijuana related securities legislation. Andrew J. Ceresney, Director of Enforcement at the U.S. Securities and Exchange Commission, gave a […]
21 CFR Part 11 Decoded: Signature/Record Linking
This is the final post in the 21 CFR Part 11 “mini-series” on Subpart B – Electronic Records. The last Section in Subpart B is 11.70 – Signature/Record Linking. In the table below, the actual language from each regulation is on the left, and my personal interpretation of what that language means is on […]
When Supplement Manufacturers, Not Athletes, Cheat
A recent article in Forbes reported that an astounding percentage of dietary supplements do not contain the main ingredient listed on the label. That’s concerning, considering there aren’t too many stringent regulations they have to follow, unlike pharmaceutical companies.
21 CFR Part 11 Decoded: Controls For Open Systems
This post is the second in the 21 CFR Part 11 “mini-series” focused on Subpart B – Electronic Records. Pull out your decoder rings and let’s look at Section 11.30 – Controls for Open Systems. In the table below, the actual language from each regulation is on the left, and my personal interpretation of […]
The Health Information Exchange (HIE) Teeter-Totter
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 […]
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 […]