Curing Document Control Conundrums: A Checklist for Sustained Efficiency and Audit Readiness

    Effective document control software systems give companies the ability to readily track and review document revision and approval his...

The Past, Present and Future of CAPA

Conclusive CAPAs: Experienced market leaders  use detailed risk gateways like the one pictured  here to establish forward-looking, comprehen...

The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients

The FDA is working with a wide variety of  stakeholders  to identify  and promote practices  that will result in higher quality devices. by...

Steak, Peas, and Doughnut Holes

Continuous improvement can lead to great success but your efforts must be focused. Food for Thought about Continuous Improvement by Curt Por...

When Is A CRO Not A CRO? (And why does that make enforcement hard?)

  It looks like a CRO. It sounds like a CRO. But is it really a CRO? by Jamie Colgin Colgin Consulting What do the following types of compan...

FDA Issues Draft Cybersecurity Guidance for Device Manufacturers

FDA has issued a draft guidance medical device  manufacturers should take to address cybersecurity risks. by Jason C. Gavejian, CIP P Princi...

CLIA vs QSR (What You Don’t Know Can Hurt You)

The Clinical Laboratory Improvement Amendments (CLIA)established quality standards to ensure the accuracy, reliability, and timeliness of pa...

One Q & a Lotta A’s about SOPs for Research Sites

SOPs or work instructions--- which does a clinical research site need? by Laurie Meehan Social Media Manager Polaris Compliance Consultants,...