Medical device makers find solution to FDA demands

Tooling & Production, Dec 2007

In the medical device industry, efficiently meeting requirements of the Food and Drug Administration is a key to business success, and Product Lifecycle Management (PLM) technology supports FDA compliance integrity by providing comprehensive content to support management decisions across the organization and the individual functional groups. PLM achieves this by uniting the information with the process and resources - people and technology - that enable medical device companies to effectively and economically ensure compliance. The following white paper from Agile Software Corporation explains how.

The FDA method for evaluating compliance is the Quality System Inspection Techniques (QSIT). As part of QSIT, the FDA targets six major quality systems that medical device companies must have in place and requires that management demonstrate knowledge on the interrelationships of activities across each of these systems.

QSIT determines compliance by auditing these subsystems and related records. The FDA has become very regimented in looking at these processes and making sure that companies have not only proper procedures to support all these subsystems, but also clear management visibility of any discrete event that happens in any one of these subsystems, and an understanding of exactly how the discrete event impacts the entire organization from a risk-management perspective.

The number of observations from FDA audits continues to increase every year with a significant impact on company performance, so meeting the expectations of the FDA should be a primary concern of any medical device company. Many of the world's top medical device companies have deployed PLM as an indispensable enterprise solution for building an automated compliance process that will meet all the FDA's stringent requirements.

PLM provides a single repository for each of the subsystems audited by the FDA - aggregated across all groups, product lines, and manufacturing sites - providing standardization and accountability of these critical processes across the organization. In addition, PLM provides the necessary management visibility across all these systems, to assess risk management and support better decision-making.

The following outlines each of the six target subsystems, explaining how PLM addresses FDA expectations and delivers associated business benefits.

Corrective and preventive action: CAPA is the key to handling quality events and preventing future quality issues. The FDA expects to see proper handling of a quality event to determine criticality and timely resolution. Managing a quality event adequately requires understanding exactly what documents, product lines, processes, etc., are impacted by the event throughout the organization, identifying what needs to be modified to solve problems caused by the quality event, and following through on corrective action.

Design controls: The FDA requires that a company's design control process provide visibility across all projects and related design activities. Periodic management reviews must be scheduled to verify project status and confirm the requirements have been achieved with documented evidence. Companies must be able to track the origin and verification/validation of design inputs, as well as ensure that original design inputs were manifested in the actual product released to market. The FDA risk-management emphasis also requires processes in place to determine how post-release changes or corrective actions impact original design specifications and controls.

Change controls: The FDA expects all medical device companies to maintain a secure, comprehensive centralized system to manage all quality procedures, product documents and manufacturing procedures, and to track all changes for easy retrieval to support QSIT audit requirements. The FDA also requires that this document-management system enables the company to identify all documents impacted by quality events and product changes.

Material controls: The FDA requires that medical device companies maintain a system to track all materials and associated suppliers used in production, to ensure the quality of those materials and that the final products satisfy design specifications. Companies must demonstrate that they have approved the material supplier and qualified critical materials as part of the development process. Analyzing material cost early in the development process is also critical in achieving price targets for new products. For released product, companies must be able to determine if any quality events are related to material or supplier performance.

Equipment and facility controls: The FDA requires medical device companies to establish and enforce one set of global standard operating procedures for all facility operations worldwide. Companies must also be able to determine if any quality events are related to equipment at a particular facility, and determine all equipment changes necessary to address a quality event.

Production and process controls: Similar to the equipment and facility controls, the FDA requires medical device companies to maintain and enforce one set of production processes across all global manufacturing operations. Companies must be able to identify any quality events related to production processes, manage how quality events and design changes impact manufacturing, and determine all risk associated with production- process changes to justify requalification decisions.