The following are my notes from the Next-Gen Information Protection announcements at Microsoft Ignite 2015. Microsoft thinks about security in three ways: Being pervasive Transparent People-centric Pervasive – policy applied to data level (when its created inside the ecosystem) so it goes with data across devices. Unified compliance – running data through compliance center across email, […]
Posts Tagged ‘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 […]
The Elephant In The (Server) Room
Server Virtualization: An amazingly helpful technological advancement that has left computer system validation (CSV) teams everywhere scratching their heads. Why? CSV calls for proof that the servers used for regulated computer systems meet or exceed the minimum hardware requirements for those systems. This is known as “hardware qualification” or “HQ.” But when the hardware […]
Using Skype For Informed Consent In Clinical Trials?
Getting informed consent from patients is one of the most critical aspects of a clinical trial. The objective is simple: provide patients with information about the study plan (doctor visits, tests, etc.) and risks/benefits, make sure they understand the information, and get their (legally effective) consent to participate. The faster this is done, the […]
21 CFR Part 11 Decoded: One Final Look
This is the final post on the series dedicated to decoding the mystical “21 CFR Part 11” regulation that governs IT systems in the life sciences industry. How does it feel to have made it all the way through? I hope that, by now, you’re feeling much more comfortable with the purpose, organization, and […]
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 […]
21 CFR Part 11 Decoded: Signature Manifestations
This is the third post in the 21 CFR Part 11 “mini-series” focused on Subpart B – Electronic Records. This time, we’re decoding Section 11.50 – Signature Manifestations. Do you have your rings ready? In the table below, the actual language from each regulation is on the left, and my personal interpretation of what […]
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 […]
The Trifecta Of Validation
Validation. Admit it – you cringed a little. It’s almost like a dirty word in our industry. That thing that slows down system implementations. That thing that adds a bunch of time and cost to IT projects. That annoying, but necessary, evil. Well, okay, it’s not really “evil,” per say. It is, after all, designed […]
How Software Vendors Can Survive The Life Sciences IT Gauntlet
The life sciences industry is up against some incredibly high standards from regulatory agencies worldwide – with good reason – so it makes sense that we, in turn, have incredibly high expectations of our vendors, especially IT. Because we have to be able to show complete traceability in our work, we need our software vendors […]
Maximizing Your Document Management System ROI Through Digital Signatures
It’s probably a safe assumption that your organization made the switch to an electronic document management system (e.g., SharePoint, Office 365, Documentum, Alfresco, NextDocs, eDOCs DM) some time ago. Take a few minutes and think back on the underlying reasons for that investment. I’m sure the list you came up with includes things like keeping […]