Marin Richeson

  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 […]

  It’s no secret that having a clinical trial management system (CTMS) streamlines and simplifies the running of clinical trials, and that Oracle’s Siebel Clinical (Siebel CTMS) is the most robust system in the space. But, as a Study Manager, what you might not know is exactly how it would make YOUR work life easier. […]

  As a member of senior management, you undoubtedly know that having a clinical trial management system (CTMS) streamlines and simplifies the running of clinical trials, and that Oracle’s Siebel Clinical (Siebel CTMS) offers an extensive list of features. But, as a Clinical Executive, what you might not know is exactly how it would make […]

  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 […]

  I’m sure you’re aware that having a clinical trial management system (CTMS) streamlines and simplifies the running of clinical trials, and that Oracle’s Siebel Clinical (Siebel CTMS) is the industry leader. But, as a Site Monitor, do you know exactly how Siebel CTMS could help YOU find your Zen amidst all of the chaos? […]

  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 […]

  It’s common knowledge that having a clinical trial management system (CTMS) streamlines and simplifies the running of clinical trials, and that Oracle’s Siebel Clinical (Siebel CTMS) is arguably the best out there. But, as a Clinical Research Associate (CRA), do you know exactly how it could make YOUR work life easier? If not, read […]

  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. 

  We all know that having a clinical trial management system (CTMS) streamlines and simplifies the running of clinical trials, and that Oracle’s Siebel Clinical (Siebel CTMS) is the leader in the space. But, working in Clinical Finance, you might not know exactly how Siebel CTMS could help YOU take a load off. Let me […]

  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 […]

  You probably know that having a clinical trial management system (CTMS) streamlines and simplifies the running of clinical trials, and that Oracle’s Siebel Clinical (Siebel CTMS) is the leading CTMS out there. But, as a Clinical Document Associate, what you might NOT know is exactly how it could be YOUR ticket to freedom. Interested? 

  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 […]