Feb 25, 2016

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

If a document control system exists to improve your organization’s productivity and help maintain a continual state of audit readiness, what rudimentary features does it absolutely need to have? The components that are deemed essential may vary slightly from one organization to the next based on individual business requirements, but the following checklist covers the minimum functionality that should be expected from a categorically complete document control software solution.

Feb 23, 2016

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, comprehensive 
CAPA programs.

by James Jardine, Marketing Communications Specialist, MasterControl

Every day, companies in regulatory environments are amplifying their efforts to avoid the seemingly inescapable consequence of an egregiously oversaturated corrective and preventive action program, or, as it’s commonly come to be known, “Death by CAPA”. A recent MedTech Intelligence article by CAPA guru Ken Peterson speaks to the evolution of CAPA, discusses the refinement of effective CAPA programs and hints at what is on the CAPA horizon in the future.

Feb 18, 2016

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 Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., and Melinda K. Plaisier, M.S.W.

Food and Drug Administration

Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms.

The metrics and assessment tools being developed are key parts of the Case for Quality (CfQ). We are working with a wide variety of stakeholders–including the medical device industry, patients, other governmental and academic colleagues, and payer/provider counterparts–to identify and promote practices that will result in higher quality devices.

Feb 16, 2016

Steak, Peas, and Doughnut Holes

by Curt Porritt

SVP Marketing


In a recent Q&A with Harvard Business Review, Sir David Brailsford, an MBA and former head of British Cycling, highlighted a cycling team that used a continuous improvement process to eventually find great success. Brailsford, who has overseen teams that have won more than a dozen Olympic gold medals and three Tour de France races, explained to HBR how his team focused on making small improvements in various aspects of cycling. The hope was that all of these small improvements would add up to a significant overall improvement in the team’s racing ability.

Feb 11, 2016

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 companies have in common?
  • Electronic data capture (EDC) software providers
  • Central image / electrocardiogram (ECG) / spirometry readers
  • Central clinical labs
  • Electronic patient reported outcome (ePRO) software providers

They're not Clinical Research Organizations.
That's right. They're not CROs.

Feb 9, 2016

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, CIPP


Jackson Lewis P.C.

Reprinted with permission

Last week (January 22, 2016), the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have entered the market, is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices in the face of potential cyber threats.

Feb 4, 2016

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 patient test results regardless of where the test was performed.

This two-part series will discuss the ramifications and realities of the FDA’s increased interest in laboratory developed tests (LDTs) in CLIA laboratories.  CLIA labs and the tests that they develop and offer have largely gone untouched by the FDA until recently (we did not say unnoticed….).  Recent draft guidance issued by the FDA (FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs); Oct 2014) reaffirms the FDA’s interest in these tests and their awareness of this segment of the industry.

Feb 2, 2016

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, Inc.

Posted on LinkedIn in 2015:

“What are your thoughts about having SOPs for clinical research sites versus having working guidelines in lieu of SOPs?”

You know how it is with those LinkedIn discussion groups.  You think you’re posting an intriguing and brilliantly conceived question that will inspire your colleagues to clear their desks, seize their keyboards, and plunge headlong into enthusiastic electronic debate. Instead, your post lands unceremoniously on the ground, with only the dullest of thuds, ignored and unloved.