A Look into ISO 14971: Risk Management and Quality System Integration MPO, July 2017
“People generally prefer present benefits over future benefits, and prefer future harms over present harms, so time-preference may need to be captured when risks and benefits occur at different times,” stated an Association for the Advancement of Medical Instrumentation (AAMI) Whitepaper: “Risk Principles and Medical Devices: A Postmarket Perspective, 2015.”
Using Automation to Manage Product Serialization and Traceability MPO, June 2017
Serialization and traceability within the life sciences industry have been around since the early 2000s. However, in order to reduce complexities, counterfeiting, and theft, efforts are being made this year to focus on serialization, tracking, and tracing to meet regulatory mandates.
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.
Integrating Training and Document Control with Automated Solutions ODT, April 2017
Companies today use many methods to maintain compliance with safety and quality regulations. Typically, training employees to maintain compliance can easily be reported on a metrics dashboard as “red, yellow, or green” and is the most efficient and effective way to communicate compliance.
How to Effectively Manage Risk in the Supply Chain MPO, November 2016
Today, most life science organizations turn to outsourcing to release products to the market faster. As such, they must be sure that their product meets compliance regulations and is within acceptable specifications. Negative deviations within a product often affect the brand owner, company image, and regulating agencies.
How the Quality Management System Streamlines the Change Process ODT, August 2016
Change is the only constant in the business world; there is always a need for it in the product or process lifecycle. The reasons vary from product upgrades to correcting defects, and the process leading up to change execution is often complicated and requires effective management in order to achieve positive results.
Tools for Maintaining an Audit-Ready State to Ensure Compliance MPO, June 2016
In the last three years, the U.S. Food and Drug Administration (FDA) issued more than 30 warning letters and 483 form inspectional observations related to electronic records. It appears the medtech industry is not sure how to comply with FDA inspection requirements. So how can the industry gain insight on this subject?
An Overview of the Tools Available to Identify and Mitigate Risk ODT, May 2016
Risk is crafty—it can take on the shape of many different forms, sizes and types, but if you look closely enough at your company’s data it is possible to take control.
Root Cause Investigation for CAPA MPO, May 2016
Medical device standards never die—in fact, they blossom. Standards are standards for a reason. This is typically because they have already been considered and accepted by authorities or chosen as general consensus for an approved model. A standard is a basic rule or principle that is used as a foundation of judgment.
Automated, Holistic Training Benefits ISHN, March 2016
Training management is the process in which an organization identifies training requirements, builds training programs, flags employees who need to be trained, and executes on that training. Doing this efficiently will help an organization ensure that they can effectively change business operations, and that its employees are knowledgeable, trained and fully able to do their job.
Getting at Root Causes - Automate and Incentivize to Reduce Your Incident Rate ISHN, February 2016
Incidents can occur on a daily basis -- including injuries, illness, chemical spills and more. To manage these events effectively and stop them at the root cause, technology is key. In this case an automated EHS System automates the process of incidents by enabling tracking and reporting on all safety incidents.
Benchmarking Risk and Compliance: How Do You Add Up? Quality Digest, November 2015
Compliance is a broad term. It can mean compliance to financial obligations, quality and safety, or general compliance to any regulation that is driving the organization. When you look at the current state of quality management and safety management with respect to compliance, most of the challenges arise in the overall operations and processes that govern companies’ adherence to common standards and initiatives.
Six Benefits of Cloud-Based Quality Management Systems Quality Digest, July 2015
When looking for the best quality management system (QMS) for your business, there are certain traits to take into consideration to ensure you get the most value out of the system in the long run. Here are six of them.
What to Look for in an Effective Corrective Action System Quality Digest, May 2015
Corrective action is an essential tool for any business. It helps to identify adverse events and pinpoint any systemic issues that must be resolved. However, a corrective action system can’t work effectively by itself.
Meeting the Requirements of ISO 9001:2015 Quality Digest, March 2015
The ISO 9001:2015 standard may still be in draft form, not quite set to replace the existing standard until the end of 2015, but it’s important to keep apprised of these changes and what they will mean for you when complying with the new standard. So what changes lie ahead? In this article we’ll look into how the new version of ISO 9001 represents not necessarily a change in the actual requirements, rather, the difference in the approach.
Five Capabilities of Effective Quality Management System Software Quality Digest, February 2015
When it comes to choosing quality management system (QMS) software for your organization, there is much to consider. Every QMS has nuances that may cause you to wonder what software will provide the most value and prove to be truly effective. Keep in mind there are basic quality management processes that effective software should automate. Look for QMS software processes that will communicate with each other to enhance the overall awareness and collaboration within your organization.
How Risk Management Improves Compliance Quality Digest, December 2014
This is the final installment in our six-part series on how automating common business processes with a quality management system (QMS) can benefit your organization. In this installment, we'll focus on risk management.
Get Greater Visibility into Audits Quality Digest, September 2014
This is the fifth installment in our six-part series on how automating common business processes with enterprise quality management software (EQMS) can benefit your organization. In this installment, we’ll focus on the automated audit management process. Audits are an important part of quality management so the ability to manage them properly is the key to an effective process.
Get more control over safety incidents with the EHS System ISHN, August 2014
As most Environmental Health and Safety (EHS) professionals know, incidents can occur daily. They happen in varying forms and levels of severity, such as injuries, chemical spills, illness, and more. To manage these incidents properly you must have the ability to document all incidents and collect as much data on them as possible. Automating your EHS system can help by enabling you to streamline the process of tracking and reporting on these safety incidents throughout your organization.
Four Reasons to Automate Your Employee Training Process Quality Digest, July 2014
This is the fourth installment in our six-part series on how automating common business processes with a quality management system (QMS) can benefit your organization. Here we’ll focus on the training management process and why automating it with a QMS results in effective employees—and makes compliance easier for you.
Why You Need Automated Document Control Quality Digest, May 2014
Document control is one of the most commonly used QMS applications in companies of any industry today. It ensures that your documents are kept up to date and controlled, and it lets you automatically route your documents from review to approval to distribution. Here just a few of the capabilities inherent in the document control system.
Five Ways Corrective Action Benefits Your Organization Quality Digest, March 2014
In the first installment of this series, we considered four traits to look for in an automated quality management system (QMS) that will provide the most long-term value for your money. Now we’ll take a more in-depth look at the automated QMS by breaking it down into its core functionalities and discussing the benefits of each. Let’s begin with the corrective and preventive action (CAPA) system.
Four Traits to Look for in a QMS Quality Digest, January 2014
Organizations today operate at speeds faster than ever before, and small to midsized businesses (SMEs) are no exception. Software solutions for quality management systems (QMS) are all too often overlooked by owners and managers of SMEs due to preconceptions about cost and ROI.