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Tips for Conquering Repeat CAPAs

Life Sciences / November 2, 2016

We previously presented a webinar titled, “Conquering Repeat CAPAs, Same problem, Different Day, Equals a Big Mess.”

When asked what people believe the weakness of their Corrective and Preventive Action (CAPA) process is, the most common answer was root cause analysis. For some, it was effectiveness check and for others, action items. Others found communication with other systems to be an issue. 

Below are some tips on using an automated Compliance Management System to resolve these issues, as well as the disappointing and ever-so inconvenient repeat CAPAs that can occur as a result.

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How to Maintain an Audit-Ready State…and the Tools that Help

Life Sciences, Quality / October 5, 2016

The goal of many companies involved in the Life Sciences world is to reach and maintain compliance with regulations set forth by agencies such as the FDA. Automated solutions help to achieve these goals and track compliance from beginning to end, while enabling systematic and objective decisions to be made.  

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3 Things to Know about Compliance Management Software

Life Sciences / September 7, 2016

In the Life Sciences, there has been an increasing level of regulatory oversight in order to ensure that companies are meeting compliance with FDA and ISO standards. In order to ensure a high level of compliance with these initiatives, while providing visibility and control, an automated Compliance Management System is critical.   

Let’s look into 3 ways a Compliance Management System increases visibility into all events that occur across your business, mitigates risks and streamlines communication with your supply chain.

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5 Benefits of a Cloud-Ready Solution for Life Sciences

Life Sciences / August 31, 2016

A Compliance Management system simplifies an organization’s daily tasks—it helps to meet the needs of compliance, while validating that this is the case. The Life Science industry must follow specific requirements and guidance set forth by regulatory agencies. In such a complex and competitive environment, organizations are challenged with meeting and maintaining high standards. This level of oversight adds another dimension to the nature of business systems.

Cloud-based compliance solutions provide the tools and the functionality needed to ensure compliance in this highly regulated industry.  

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4 Traits of an Effective Complaint Handling System

Life Sciences / August 17, 2016

Complaint Handling is one of the most significant components of a Compliance Management solution for the Life Sciences.  It manages the investigation and resolution of customer complaints and ensures compliance with FDA guidelines in the process.

Automated Complaint Handling solutions provide consumer feedback for an organization and enables them to measure and analyze the market with respect to product quality and compliance.  FDA-regulated organizations in particular need a solution that will automate the process of handling complaints while providing an efficient method for collecting post-market data and quickly turning this data around to improve quality and compliance. 

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Risk Management and the Importance of Setting Risk Parameters

Life Sciences / August 10, 2016

Organizations in the U.S. Life Science industry must abide by rules and regulations set forth by the FDA. The FDA has placed
significant oversight on adherence to specific requirements around compliance with regulations such as 21 CFR part 820 and part 11.

To effectively achieve compliance, organizations must have visibility into all adverse events and the risk these events pose on the organization. Risk Management tools provide the framework for handling these adverse events in a systematic way.

Risk Management tools keep you in control by giving you the ability to catch events at the root cause.

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Tools for Managing Risk in a Global Supply Chain

Life Sciences / July 20, 2016

Complexity is a growing theme in quality and compliance management, specifically in regards to the supply chain. This is because now, more than ever, there is great competition in the market. Competition leads to shorter product lifecycles, increases product complexity and creates a variety of goods in more areas. Companies need to maintain compliance and keep up with the intense pace of business in order to keep quality and safety considerations in line.

The Compliance Management System is designed to automate and manage processes related to quality and compliance and extend them to the supply chain. 

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Are You Single Handedly Managing Consumer Feedback within Your Company? A Tale of How Automation Can Help

Life Sciences / July 13, 2016

There once was a girl who was in charge of managing and analyzing the consumer complaints and feedback of her company. Her job was to ensure that there was a complete record of all complaints with information about the product and the customer. She singlehandedly had to make sure her company was in compliance with FDA and GMP guidelines.

As her company grew and grew, manual processes were getting out of control. She couldn’t keep up it was just too much! She was constantly bombarded with papers and using a manual, paper-based system for the data was just not working anymore. She couldn’t find the time to track even the most critical items. That’s when she knew times have changed and in order to keep up, she would have to turn to the world of automation.

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Risk Management in the Medical Device Industry: How Do You Measure Your Risks?

Life Sciences / July 6, 2016

Risk is prevalent in all industries.  In the Life Sciences in particular, organizations must be extremely careful to ensure the safety and quality of all products, as they affect health and well-being. It's critical for those in the medical device industry to stay on top of possible risks to ensure each product is of the highest level of quality to ensure the safety of consumers.

One of the best ways of assessing risk within the medical device industry is through automated risk management.

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How to Prepare for, Manage and Follow-up an FDA Inspection: A Risk-Driven Approach

Life Sciences / June 22, 2016

Life Science organizations create products and devices meant to improve quality of life of consumers. Whether these goods are produced on-site or are imported it is important that they are properly created. Device Manufacturers are often challenged with the maintenance of quality goods as well as FDA compliance.

Having Compliance Management Software to ensure regulatory compliance and automate business processes is critical to these organizations.

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