When Does it Make Sense to Automate EQMS?

When Does it Make Sense to Automate EQMS?

Adonna Blasko, Marketing Manager, Pilgrim Quality

You need to manage your quality system, and you might think you have everything under control with a manual process. But manual processes including disparate tracking systems for controlling documents, deviations, customer complaints, change controls, and other quality processes are often cumbersome and difficult to control, with limited to no visibility across processes.

So when is it necessary to bite the bullet and adopt an automated enterprise quality management system (EQMS)? The timing may not be the same for every organization, but you should examine your quality management processes and see where quality management software can help fill in the gaps, creating a more cohesive closed-loop process and better preparing you for any internal audits, regulatory inspections, or regulatory reporting. (more…)

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection

Roxane Napoli, Marketing Manager, Pilgrim Quality

You’re probably conducting incoming inspections today but if you aren’t taking a risk-based approach, chances are you’re performing inspections you don’t need to do and possibly overlooking the items which need to be inspected most.  Implementing a risk-based sampling system helps you spend less time and less money inspecting high-quality raw materials when you are already confident that they are good. You’re also able to pinpoint poorly performing raw materials and suppliers based on their inspection state. (more…)

Unannounced Regulatory Audits Hitting Global Med Device Community

Unannounced Regulatory Audits Hitting Global Med Device Community

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality 

No one likes to be caught off-guard. Have you ever had a contractor show up at your home before you’ve even woken up? Or your child tells you he needs his original birth certificate the very next morning to register for camp. These facts of life often arise when you least expect it. (more…)

eMDR: 3 Reasons Med Device Manufacturers Should Go Electronic Now

eMDR: 3 Reasons Med Device Manufacturers Should Go Electronic Now

Adonna Blasko, Marketing Manager, Pilgrim Quality

We’ve already covered the impact of recent eMDR regulation updates on the industry (the overall benefits for patients and the health care community as a whole) in a previous post. Now let’s take a closer look at why medical device manufacturers may not want to delay their transition to electronic medical device reporting. (more…)

The ACK Facts: Truths About eMDR Acknowledgement Files

The ACK Facts: Truths About eMDR Acknowledgement Files

Adonna Blasko, Marketing Manager, Pilgrim Quality

When it comes to adverse event reporting and eMDR, understanding how things work plays a role in your organization’s success. This is especially true with acknowledgement files (ACKs), as they determine whether you have met your regulatory reporting requirements. (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

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…)

FDA Final Ruling on eMDR: The Impact on the Industry

FDA Final Ruling on eMDR: The Impact on the Industry

Adonna Blasko, Marketing Manager, Pilgrim Quality 

Have you heard the big news? All mandatory 3500A MedWatch reports submitted by medical device manufacturers and importers must be now submitted electronically. On February 14, 2014, the FDA released its final decision on electronic Medical Device Reporting (eMDR). By August 14, 2015, all medical device manufacturers and importers will be required to submit mandatory 3500A electronically to the FDA’s Center for Device and Radiological Health (CDRH). We’ve been waiting for this final decision since 2009 when the rule was proposed and opened for public comment. (more…)

A Market-Leading Approach to Quality Performance Management

A Market-Leading Approach to Quality Performance Management

Matthew Littlefield, President & Principal Analyst, LNS Research

Because of the competitive nature of the industry, most life sciences quality leaders are laser-focused on performance management. It not only helps to keep you in check, performance management is a critical component of continuous improvement initiatives as it provides visibility into what’s working effectively and what might require more people, processes, and technology resources.

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The 5th Incarnation: Proposed Changes to ISO 9001

The 5th Incarnation: Proposed Changes to ISO 9001

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality 

Are radical changes coming? Is this fifth incarnation of ISO 9001 a drastic departure from its predecessor? Will it reshape the world of manufacturing as we know it? Word around the water cooler is “No.” (more…)

How to Gauge Your Quality Management Technology Maturity

How to Gauge Your Quality Management Technology Maturity

Matthew Littlefield, President and Principal Analyst, LNS Research

With pressures to drive down costs while improving innovation and the safety of products, life sciences companies need close integration between risk, quality management, and compliance. Conventionally, this connection has been facilitated by a number of homegrown and manual solutions. However, with the unprecedented complexities associated with the industry today, most organizations require something more robust. (more…)