Pilgrim Quality Solutions Posts

eMDR to Become Mandatory – Ready, Aim… WAIT!

eMDR to Become Mandatory – Ready, Aim… WAIT!

The FDA’s Center for Device and Radiological Health (CDRH) has had a focused project team engaged in developing, educating, communicating and assisting medical device companies on how to submit Adverse Event reports (MedWatch 3500A) in an electronic format, now known as eMDR (electronic Medical Device Report). In 2005, Indira Konduri, eMDR Project Manager, solicited help from industry to move forward on the testing and confirmation of the eMDR requirements. The solution leveraged the Health Level 7 standards (HL7) and the outcome was an Individual Case Safety Record (ICSR version 1). Kudos to the eMDR team during this period when the FDA showed an incredible ability to “listen” to the voice of industry and displayed a willingness to engage in joint discussions on the best way to handle issues. (more…)

Are They Just Pulling Our (Supply) Chain?

Are They Just Pulling Our (Supply) Chain?

The FDA, Congress, the US Consumer Products Safety Commission, US Immigrations and Customs Enforcement, the Department of Justice. These and countless other regulatory bodies are more proactively evaluating the potential risk and liability to our country’s goods and products; and as we’ve seen, the sharing of information among these regulatory bodies is leading to more cohesive enforcement activities with the continuous goal of protecting the consumer. (more…)

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

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…)

Wake Up and Watch Out: Getting Serious About QMS

Wake Up and Watch Out: Getting Serious About QMS

“If it’s not broken, don’t fix it.” Really? If you only want to maintain the status quo, you might get away with letting sleeping dogs lie. But no one really wants to get hauled off by the dog catcher during a pleasant nap. Unfortunately, it’s happening every day to manufacturers who don’t take quality management or QMS seriously.

Quality management is about continuous improvement and product safety. And each time we optimize, we strengthen our preventive measures for avoiding unwanted surprises and disruptions in our operations. (more…)

Risk Management Software is Crucial

Risk Management Software is Crucial

Every company, no matter how large or small, faces a number of pressing internal and external risks, any of which, whether singly or in combination, could pose a serious threat to long-term viability and short-term revenues. Some organizations treat risk management as an art, and allow their management to use their best judgment in order to avert disaster–but increasingly, savvy corporations are taking another tack. Risk management software can help take the guesswork out of avoiding unknown pitfalls, and put the power of self-determination back in the hands of your company’s decision-makers. (more…)

Supplier Quality Management Software is Key for Business

Supplier Quality Management Software is Key for Business

Supplier quality monitoring and management is a critical activity for any large company. By keeping a close watch on the performance of the companies you do business with, you can quickly and efficiently diagnose problems in your supply chain, and streamline the flow of goods that keeps your business alive.

Supplier quality management software helps automate the process of tracking the cost of poor supplier quality. A well-made supplier quality software product will also provide ways of logging complaints, corrective actions taken, and several other related types of information. (more…)