Audit Posts

MDSAP is Flying on Auto Pilot through 2016

MDSAP is Flying on Auto Pilot through 2016

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). Forum members agreed that this global approach to auditing and monitoring medical device manufacturing could improve product safety and oversight on an international scale.
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Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Recently, we hosted two live demonstrations of SmartSolve Audit Management. The webinar covered a number of topics including how to perform mobile audits, creating audit programs and schedules, working on audits, and managing audit followup.  The webinar also included live Q&A during both sessions.

Some key themes emerged during both sessions that helped us understand the challenges you may encounter when carrying out quality audits, and how SmartSolve Audit Management can help.

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How to Prepare for Your Next FDA Inspection (Free E-Book)

How to Prepare for Your Next FDA Inspection (Free E-Book)

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Think about your next FDA inspection. How will you feel when the inspection arrives at your facility? Will you be rushed or calm? Flustered or confident? Perhaps more importantly, who will control the direction of the inspection? You… or the inspector? (more…)

The Role of the Internal Quality Auditor

The Role of the Internal Quality Auditor

Konyika Nealy, Vice President of QA and Validation, Pilgrim Quality Solutions

As an experienced member of your organization you may at some time be called upon to conduct an internal audit. This is a good thing. Internal audits are intended to preempt issues that can arise during a second or third party audit. This type of peer review though, if not managed correctly, can have negative consequences that undermine its value. (more…)

Time For SaaS?

Time For SaaS?

Michael Reynolds

Outsourced Enterprise Compliance and Quality Management  — application and data management in the form of Software as a Service (SaaS) — is a partnership needed more  today than ever, particularly in the increasingly complex regulatory environment that Pharma, Biotech and Medical Device companies find themselves. (more…)

Product Liability: How Exposed Are You?

Mark Crawford

According to regulatory compliance expert James Kolka, management too often ignores the legal and financial threats posed by product liability lawsuits.

“Management often believes that compliance with FDA’s Quality System Regulation (QSR) protects the company from product liability exposure,” says Kolka. “Consequently, the task of product liability management is invisible and not audited. It seems to materialize when there is a lawsuit and a mad scramble to find who is or should have been responsible.” (more…)

The New Year is a Good Time to Think About Audits

From December 26th on, you can’t help but see articles on the best and worst of 2010. We had Toyota, BP and eggs topping the news, and it didn’t shed much of a positive light on quality management. So as the new year kicks in, perhaps it’s time to examine your own products and processes in order to ensure compliance with organizational and industry regulations. (more…)

The FDA Devotes Almost Half of its Staff to Product Regulation – Shouldn’t They Eat Their Own Dog Food?

Compliance and Quality management is crucial issue for almost any business, large or small. No matter what medical product your company manufactures or services, it’s a virtual certainty that you are beholden to an array of different regulations, both internal and from the FDA such as cGMP quality systems. Ensuring that your company remains in compliance with these regulations and proving the quality and safety of products and services at all times is something that can’t be left to chance. (more…)