The end result objective of a corrective and preventative action (CAPA) is, quite simply, a solution to the issue from which the CAPA was generated. If it is not driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella—all control points flow through to the CAPA system.
April 4, 2017
By Paul Sanderson, Solutions Consultants Manager, MasterControl
“Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone.
Let’s play a quick word association game. If I say CAPA, I’m betting someone will say manufacturing. The concept of corrective action and preventative action is indeed associated with product quality in manufacturing because of long-standing regulations and standards requiring CAPA in that sector. However, MasterControl’s Patricia Santos-Serrao says you can and should leverage CAPA principles in clinical research.
November 3, 2015
By Marci Crane, Staff Writer, MasterControl
Although a long list of candidates make up the list of “eligibles” for the 2016 Presidential election, it’s fairly apparent that the two most conspicuous candidates are, respectively, Democrat Hillary Clinton and Republican Donald Trump. These two candidates, though liked and disliked by various population pockets across the United States, have certainly managed to make names for themselves within their various areas of expertise.
July 28, 2015
By Kelly Thomas, Atlantic Validation
Successfully completing a FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection management techniques can help mitigate the risk of receiving an observation for compliance gaps. This article will provide insight on understanding the inspector, discuss how to prepare for and manage the actual Inspection, describe follow-up activities required for close-out, as well as describe real-life lessons learned.
June 2, 2015
By Dr. Bob Strong, SAI Global Assurance Services
A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.
February 10, 2015
By Ken Christie COO, VTS Consultants, Inc.
If there is one word within the life science industries that causes concern and anguish it is “audit.” As with any evaluation process, the success of getting through a regulatory audit is a combination of preparedness with regards to what to expect, knowing the current regulations that apply to your product and knowing what tends to be the areas of deficiencies in audits performed. All of these items can be researched on the web and the time and effort to review and provide training on them will serve companies well.
Using ISO parlance, a management system is designed to achieve objectives. In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers. A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.
Each year, the most popular learning course we provide is targeted at developing the skills necessary for our customers’ associates to implement their corrective action programs effectively and efficiently. Throughout the years, we have been asked the same question hundreds of times, “What are the most common reasons corrective actions fail?” Usually this question is asked during the corrective action learning session by a management team member hoping that we will deliver the message to the other team members that they are failing. Normally, we turn the question back around to the group and ask them why they think their corrective action program fails. The most common answers we hear are: limited time, resources, training, or not knowing which tools to use.