In the life sciences industry, the process of managing non-conformities or defects from manufacturing, engineering, quality or other quality data sources, such as product complaints leading to corrective or preventive actions, should be a formal and controlled process that is used to identify, correct and prevent problems. Today, the industry is facing strong pressure from regulatory bodies—government as well as from the industry itself—to focus on quality and, at the same time, the need to increase asset utilization and efficiencies, and lower cost as much as possible. A corrective and preventive action (CAPA) program is one tool to achieve these objectives. A key part of a CAPA program is root cause analysis, which is utilized to ascertain the source of a problem, non-conformity or defect so that corrective or preventive action can be taken to address the issue.
If you are conducting: GRC/ Quality Assurance/Regulatory Affairs directive especially in, Quality Management/System initiatives in Training, Change Management, Audits, Inspections, CAPA, Risk Management, Document Control, Product Specifications, Returns, Document Management, Inspections, Walkdowns, etc. VQS will help you to easily manage all aspects of your organization’s quality program. This includes but not limited to
The federal government is not in the business of developing new technologies, but they are in the business of investing in them. If you are planning to develop, computer-based products and Read More
Regulatory Agencies have developed a set of expectations for companies who develop and operate computer systems in regulated spaces. Read More