Posts Tagged ‘computer systems validation’

Top 5 Pharma & Medical Device Blog Posts From June 2017

Now that July is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in June – they’re ranked in order of popularity, with number one being the most viewed piece. What Exactly Is An “Adverse […]

21 CFR Part 11 Is Complicated Enough, So We Stripped The Legalese

If that title compelled you to open this post, then you know what 21 CFR Part 11 is, and you also know – as my 12-year-old step daughter would say – “the struggle is real.” 21 CFR Part 11 is perhaps the most famous (or infamous!) regulation published by the U.S. Food and Drug Administration […]

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 […]

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 […]