“Quality, quality, quality.” You hear it all the time from your QA colleagues. There are so many forms to fill out, trainings to complete, procedures to read and follow, and internal audits to produce records for. Sometimes, it’s so overwhelming that we’re tempted to just tune it out. That is, until we read an FDA Warning […]
Marin Richeson
Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.
Blogs from this Author
Bug Tracking Systems Aren’t Just For Bugs
Here in Perficient’s life sciences practice, we use a defect tracking system as part of our application development process. It helps us keep track of bugs and resolutions as we develop and test, but there’s nothing particularly remarkable about it…except that we use it for another purpose too: to track problems with our QA controlled […]
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 […]
Tracing The Roots Of Regulations
The life sciences industry is one of the most heavily regulated in the world, which can make it a frustrating space to do business. But, retracing the current mass of regulations back to their roots can be like the spoonful of sugar that makes the medicine go down…and might even make you feel kinda good […]
Why Bother With Computer Systems Validation?
It’s no secret that validation can be a bear. All of that documentation and testing, the multiple phases with pesky transition gates, a million reviews and approvals…it can really slow down an IT project, which often leads to questions about why on Earth we bother with it. Well, it all traces back to rules and regulations […]
How Many Environments Do You REALLY Need?
A couple of weeks ago, a client of ours discovered a problem in the production (PROD) environment of one of their clinical systems. In the initial system implementation, they had opted for a single environment (without a sandbox, development, training, test, or validation environment), so they found themselves with no separate environment in which to […]
The Best Way To Get CTMS Data From Your CROs
There’s a clear trend in the life sciences industry toward outsourcing clinical trial management to clinical research organizations (CROs). If you decide to join the movement, how should you go about getting data from your CROs into your clinical trial management system (CTMS)? The most common method is to collect reports from CROs in the […]