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With new products to market faster, customer satisfaction and compliance to FDA regulations, medical device manufacturers need to rethink their strategy for consistent, enterprise-wide compliance management. The new strategy must additionally help manufacturers increase their operational efficiency and accelerate operational performance to global standards. FDA's Quality System Inspection Technique (QSIT) is the primary inspection program for the medical device industry. QSIT lays emphasis on systems and sub-systems within the organizations quality system. During quality inspections, investigators focus on specific subsystems such as - Management controls, Design controls, Production and process controls (P & PC) and Corrective and Preventive actions (CAPA). The FDA views CAPA as being directly linked to all of the other subsystems and the FDA code for CAPA defined by 21 CFR 820.100 requires strict control and management of these corrective and preventive actions.

There is an increasing trend for organizations to turn towards Enterprise-wide CAPA management systems that provide business process quality and performance analysis with real time visibility into quality processes. This is done with an aim to help drive their quality improvement processes towards regulatory compliance and greater return.

CAPA Management Solution - Ensuring Enterprise-wide Regulatory Compliance "CAPA is used for correcting existing product nonconformities or quality problems, and preventing the recurrence of the problem."

The process of tracking and managing corrective action reports is an enormous undertaking and activities that surround the management of corrective and preventive actions for the medical device industry, can sometimes be time-consuming, expensive and error prone. Additionally, organizations need to address the underlying root cause of any and all problem areas, since this helps them avoid similar or related problems in the future. To ensure a robust CAPA program, medical device manufacturers need to analyze FDA trends in CAPA citations and review common CAPA 483s. They also need to review the motive behind the FDA's focus on QSIT inspections, and its impact on organizational compliance. Manufacturers need to be aware of the various types of failure investigations and triggers that the FDA looks for when auditing their CAPA program. FDA investigators need to be provided with proof and documentation that corrective and preventive actions have been implemented within the processes. Manufacturers need to conduct effective internal audits to prepare for FDA inspections and identify outside sources of non-conformance input to their CAPA system.

Device manufacturers can establish a comprehensive corrective action plan that prioritizes and tracks the progress of projects towards assurance. They can also condense the CAPA process by learning to isolate the true root cause faster while identifying the best possible corrective action. Manufacturers must provide well-defined roles and responsibilities for personnel, involve teams in the process and have a solid tracking capability to minimize regulatory risk. They also need to audit the impact of product deviations on other areas such as plant systems, material systems, or test methods as well as track and complete deviations under stipulated time frames. Medical Device manufacturers need to incorporate easy methods for maintaining effective CAPA documentation while keeping their documentation thorough and consistent.

Web-Based CAPA Management System
Device manufacturers can now automate these processes, through an effective CAPA management system that ensures enterprise-wide regulatory compliance and forms the basis for all quality improvement programs. In order for device manufacturers to make their CAPA management systems function efficiently, manage and resolve corrective and preventive action effectively and meet FDA regulations, its important that they take the initial steps to consolidate information. This is possible with tools that are provided by web based enterprise-wide software system solutions that allow for device manufacturing personnel to carry on with their individual day-to-day responsibilities while enabling them to integrate information from across the enterprise.

• Web-based enterprise-wide solutions allow global access, and device manufacturing personnel whether they are employees or management, can now easily analyze data through a Web browser and be in touch with customers, suppliers and business partners no matter where they are. As this solution enables connecting to any type of database, medical device manufacturers who have customers several states away can track their customer order's and provide them with access to enable retrieval of relevant data in real-time.
• The enterprise-wide system being fully web based allows organizations to connect globally between multiple departments and branches, and information can be accessed by multiple platforms, be it Macintosh, a Windows PC or UNIX, thereby ensuring that the sharing of critical information quickly and efficiently is no more an issue.
• Today’s enterprise-wide CAPA management systems are not only scalable, but ensures that data is easily accessible to a potentially large base of users, is highly secure and allows these systems to function from anywhere in the world on a computer with any operating system. That means any CAPA solution must demonstrate the ability to be used in an intranet or Internet environment, be secure and highly scalable.
• Corrective action systems for enterprise-wide applications are designed to meet regulatory requirements, manage the customer complaint resolution process, address audit related nonconformance, and manage product quality issues. These applications are designed to manage the corrective action processes in any business process such as R&D, Purchasing & Supplier Management, Manufacturing, Distribution and Customer Service.
• An enterprise-wide CAPA management system should be able to involve its users in the design and implementation to ensure that the system meets real world organizational issues. The system must also function, without plug-ins or additional software requirements for viewing or querying data, as well as perform tasks such as designing forms and work flows or setting up new users from the web browser, thereby making it truly zero-client and Web based.
• The CAPA system must easily integrate with legacy systems to avoid duplication efforts and provide ease of use. It should also integrate with any e-mail system that is currently at use in the organization, or one that the manufacturer may migrate to eventually. The system must seamlessly link with existing business intelligence systems and provide the ability to identify root causes and perform trend analyses and other critical reporting functions.

• An effective CAPA system helps deal not only with immediate manufacturing related issues but also the entire well-being of the system processes, by addressing the root cause of issues as well as helping comply with FDA requirements.
• Device manufacturers can benefit through improved work processes that shorten cycle times and increase efficiency as well as effectiveness.
• The system provides a 21 CFR 820.100 validated solution to manage key business processes for quality assurance and regulatory compliance.
• The system helps streamline processes towards management review while providing greater control by reporting on key metrics.
• With the CAPA management system in place there is a pronounced acceleration with regard to closure of corrective actions as well as access to information and device manufacturers can see this improvement happening at a rapid pace.
• With the system connected across the organization, the quality engineers can now assign issues to respective categories and departments. They can focus on more pressing activities, and other problem areas that need their expertise.

The MetricStream Solution - Power Your Enterprise
MetricStream's Corrective and Preventive Actions (CAPA) is a system of structured documented actions taken to address existing product or quality problems. The CAPA module is 100% web-based and can be used by shop floor personnel, receiving dock inspectors and customer service representatives to record product, process or supplier non-conformances.

The key features of the CAPA module are:

• Login and Security - Quality*Stream supports single sign-on across all applications, 128 bit encryption, SSL, state-of-the-art technology stack and provides data access control.
• Action Report forms - The system provides pre-configured templates to record corrective action requests (CAR) in response to customer complaints, in-process defects and incoming supplies defects, in addition to containment and preventive action reports.
• Workflow and Routing - The system features a business process modeler that enables CARs to be routed-for-resolution automatically to a hierarchy of users including coordinators and problem owners, complete with notification and escalation procedures.
• Module Integration - The CAPA module seamlessly integrates with other modules like Audits, Inspections and Training and allows a CAPA to be triggered automatically from the Audits or Inspection module as and when a need for corrective action is identified. Additionally, the knowledgebase of CAPA events and resolution history can be used as employee training material as part of a corrective action to a problem.
• Metrics and Reports - Users can obtain comprehensive on-demand reports on CAPA details and event histories, or generate personalized CAPA metrics by status, product, or department.

MetricStream’s seamlessly integrated suite of web-based products, facilitate enterprise-wide deployment and assist customers throughout all phases of installation and deployment.

MetricStream’s quality and performance management solutions help Medical Device Manufacturers benefit significantly through the use of software solutions that enable regulatory compliance and increase operations efficiency. Through our enterprise-class quality management solutions (QMS) we can help power organizations by reducing administrative and operating costs, achieve business objectives, competitive advantage and increased market share. For more information on implementing solutions for your enterprise, please contact us at 1-650-620-2955, or by email at info@metricstream.com