Articles

Three Questions to Master Continual MDSAP Conformity

MPO, March 2019
Product recalls frequently make headlines and tarnish brand reputations as a result. In today’s digital world, one bad customer experience with quality can be broadcast in seconds, giving brands little time to react.

2019: The Year to Enhance Quality in Orthopedic Product Development

ODT, February 2019
The world has gone digital, and now it’s time for orthopedic product developers and manufacturers to catch up.

MDSAP Audits Update: Progress, Challenges, and a Cost Reduction Case Study

ODT, November 2018
The Medical Device Single Audit Program (MDSAP) is growing fast, with 3,629 sites now participating, as compared to just 788 at the end of 2017.

Food safety Traceability Challenges

ISHN, September 2017
According to the Grocery Manufacturers Association, the majority of companies who go through a Class I recall can expect to see $10 million or more in losses as a result. In fact, nearly one in four companies report losses in excess of $30 million for a single recall.

Six Document Control Problems for Medical Device Firms to Avoid

MPO, September 2017
Homegrown systems and paper-based processes can create unnecessary risk for medical device companies when it comes to document management. From policies to manuals, regulatory reports to standard operating procedures (SOPs), these companies deal with a staggering number of documents on a daily basis.

4 FAQs: Medical Device Single Audit Programs

ODT, August 2017
Audits and inspections are essential parts of medical device manufacturing. Yes, they can be a pain point for many organizations since they require a lot of preparation and may happen unexpectedly. But they are an essential way to keep manufacturers accountable, which in turn, keeps patients using their devices safe.

How are OSHA Regulations Impacting Company Culture?

ISHN, August 2017
Regulations and standards aren’t just designed to tell you what to do. They’re guidelines for shaping the way your organization as a whole operates, thus shaping your company culture. The latest standards from the Occupational Safety and Health Administration (OSHA) put practical measures in place to improve safety, but also engrain safety as a priority within company culture.

Four frequently asked questions about behavior-based safety (BBS)

ISHN, August 2017
BBS is the application of behavioral psychology to improve safety in the workplace through correcting behaviors that cause incidents and promoting behaviors that are efficient and safe.

Applying Risk-Based Thinking to Operations

Quality Digest, July 2017
The dynamic of risk management and compliance seems to be experiencing a shift toward risk management in operations, and learning to pay attention to detail in order to leverage it.

Wearable Mobile Solutions to Improve EHS & Performance Management

ISHN, July 2017
In 2016, the National Institute for Occupational Safety and Health (NIOSH) empowered miners with a new wearable device according to Centers for Disease Control and Prevention. NIOSH researchers have documented that a continual personal dust monitor (CPDM), (which is a wearable device that monitors the amount of dust in the miner’s breathing) has created a 90% decrease in dangerous levels of dust for miners reducing pneumoconiosis (black lung). The CPDM monitors the wearer’s zone and is detected and updated in a digital readout.

A Holistic Approach to Quality and Supplier Management

MPO, July 2017
Those who outsource to fulfill manufacturing needs already know that suppliers are an integral part of a company’s operations. In fact, the relationships with suppliers might be some of the most influential a company will make. So how does one make the most out of those relationships to ensure a mutual benefit between both parties?

The Importance of an Integrated QMS Within Regulatory Industries

ODT, May 2017
The life sciences market is constantly evolving, and automated quality and compliance solutions must follow suit. The ability to interact, collaborate, and coordinate across the board is key to uncovering gaps in processes and creates visibility between operational areas. Adopting a harmonized process with an automated Quality Management System (QMS) will enable users to assess risks and standardize processes while keeping up with regulations.

Four Takeaways from Recent Regulatory Audit Changes

MPO, May 2017
From medical device production to pharmaceutical manufacturing, the life sciences demand highly regulated operations. In a perfect world, these products would be without defect every time, but the reality is processes can stray from compliance and cause quality issues that affect people’s health.

Three Places for Risk Management in Life Science Organizations

ODT, March 2017
By now, the concept of risk probably isn’t a brand new one—it has entered into many regulations, standards, and best practices. Risk-based thinking has become a cornerstone in many industries, especially those as critical as the life sciences. However, that doesn’t mean organizations aren’t still learning how to best apply risk techniques to their operations.

Harmonizing ISO Standards with an Integrated HSEQ System

ISHN, March 2017
No matter their specific needs, organizations have goals above and beyond daily business tasks. For example, some have sustainability initiatives to work towards, while others want to increase internal and external engagement.

Track leading indicators, flag risks & verify mitigation

ISHN, March 2017
As part of the process of continual improvement, it is important that all incidents and accidents are recorded and investigated, and actions are taken to prevent or reduce the chance of recurrence. To ensure continual improvement, it’s imperative to consider safefty in all aspects of an organization.

3 Benefits of Centralizing Your Operations with a Document Control System

Quality Magazine, January 2017
Implementing a document control system is a good way to improve your processes, no matter what industry you are in. Having everything in one place helps you organize and handle your processes, job descriptions and other important material. The benefits, however, spread far beyond just document storage. All aspects of your organization can benefit from a centralized document control system.

Strategies for Effective Audits in the Medical Device Industry

MPO, January 2017
Even when they are planned, audits often bring uneasiness to many businesses. People either fear failure or are overwhelmed by the seemingly complicated processes. However, if organizations understand the importance of audits and how to increase their efficiency and effectiveness, their benefits can be recognized.

Applying risk management tools

Safety+Health Magazine, June 2016
In the environmental, health and safety industry, emphasis is placed on reducing job-related incidents and increasing the level of workplace safety and compliance. Anything that jeopardizes those priorities needs to be contained and prevented from happening again. Risk management tools provide a systematic method for handling such events with consistency and objectivity.

How Automation Ensures Improvement: Change Management in Quality Management Systems

Quality Magazine, April 2016
Change is common within the life sciences industry, where a product may be designed only once but change occurs often throughout the product lifecycle. An organization’s ability to incorporate quality into every aspect of a change results in overall product quality with less chance of recall. This is where change management comes in. Using the enterprise quality management system’s (QMS) automated change management process, quality becomes the foundation of every product or process throughout the product lifecycle.

How Automation Ensures Improvement: Change Management in Quality Management Systems

Quality Magazine, April 2016
Change is common within the life sciences industry, where a product may be designed only once but change occurs often throughout the product lifecycle. An organization’s ability to incorporate quality into every aspect of a change results in overall product quality with less chance of recall. This is where change management comes in. Using the enterprise quality management system’s (QMS) automated change management process, quality becomes the foundation of every product or process throughout the product lifecycle.

The Benefits of Automating Your Document Control Process

Quality Magazine, April 2016
In the world of manufacturing, there are inherent risks, whether related to product manufacturing or common risks that exist throughout the organization. To improve overall safety within the workplace, these risks must be identified and prevented.

How to Reduce Your Organization’s Risks Using Job Safety Analysis

ISHN, March 2016
In the world of manufacturing, there are inherent risks, whether related to product manufacturing or common risks that exist throughout the organization. To improve overall safety within the workplace, these risks must be identified and prevented.

The Role of Risk Management in Compliance: Tools for Success

MPO, March 2016
Organizations today are more complex—businesses are increasing their global footprint with a worldwide scope of locations around the world. This, coupled with the addition of mergers and acquisitions, results in disparate trends in compliance. Companies in the life sciences need to address their impact on both quality and compliance as they grow; however, there is a dissonance in how compliance is organized once a company expands in complexity.

How Automated EHS Software Paves the Road to Success

ISHN, February 2016
Environmental Health and Safety (EHS) professionals are responsible for maintaining a high level of both safety and compliance within the organization.

Global Harmonization: The Key to Compliance that Spans the Supply Chain

MPO, February 2016
Business today has become increasingly global in nature. Life science organizations in particular often extend manufacturing to suppliers who are located around the world. For suppliers to effectively operate within this global environment, a harmonized solution is needed.