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Posts Tagged ‘digital signatures’

Who Should Notify The FDA About Using Esigs: CRO Or Sponsor?

  Several months ago we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Regarding “the organization” that needs to inform the FDA of the intended use of electronic signatures, in a CRO/Sponsor relationship, who is responsible: the […]

21 CFR Part 11 Decoded: Controls For ID Codes/Passwords

  Welcome to the final post in the 21 CFR Part 11 “mini-series” on Subpart C – Electronic Signatures, which happens to be the final section in the 21 CFR Part 11 regulation. Let’s polish up our decoder rings one last time for Section 11.300 – Controls for Identification Codes/Passwords. In the table below, the […]

21 CFR Part 11 Decoded: E-Signature Components and Controls

  This post is the second in the 21 CFR Part 11 “mini-series” that is focused on Subpart C – Electronic Signatures. Today, we’ll be using our decoder rings to learn the secrets in Section 11.200 – Electronic Signature Components and Controls. 

21 CFR Part 11 Decoded: Electronic Signature General Requirements

  Welcome to the first post in the 21 CFR Part 11 “mini-series” focused on Subpart C – Electronic Signatures. We’ve come a long way since that first post in which we decoded what the name “21 CFR Part 11” even means, haven’t we? We are in the final stretch! Let’s get out our decoder […]

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 […]

Perficient’s Top 10 Life Sciences Blog Posts of 2014, Letterman-Style

As we wrap up 2014, I thought it would be neat to see what our readers were, well, reading. Without further ado, here are the top 10 blog posts Perficient’s life sciences practice wrote that seemed to be popular among readers. They’re ranked David Letterman-style, one being most popular (i.e., viewed). The One Feature CROs and […]

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 […]

Using ARX’s CoSign to Digitally Sign PDF Documents [VIDEO]

Digitally signing documents is easier than you might think. It’s also much faster than having to print, sign, and scan them. And, of course, there’s a significant cost-savings for companies that frequently mail and store hardcopy documents. A product like CoSign can be a great solution for companies, especially those in highly-regulated industries that require […]

45+ Documents That Life Sciences Companies Can Sign With Digital Signatures

I recently attended a webinar titled “10 Killer Applications for Digital Signatures in the Life Sciences Enterprise,” in which Rodd Schlerf from ARX, the maker of CoSign, discussed how various departments in a life sciences organization can make use of digital signatures. Although the list I gathered below from the webinar is just a glimpse of […]