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Automating the process of Regulatory Compliance for Medical Devices

FDA regulatory compliance is a mission-critical requirement for medical device manufacturers. If the FDA finds a manufacturer to be non-compliant to or in violation of FDA rules, the consequences can be severe with warning letters, mandatory product recalls, temporary shut-downs, criminal penalties and fines depending on the severity of the violation. These penalties imposed by FDA could seriously dent the manufacturer's brand image and at times could even cripple the manufacturer financially.

In such a scenario, it becomes imperative for manufacturers to ensure compliance with FDA regulations while improving the efficiency of their operations as well. Compliance software solutions provide the manufacturer with the ability to document a problem/s, identify the root-cause, analyze and take corrective actions, provide the manufacturer with a documented proof that the corrective action was implemented and the problem was resolved and enable regulatory reporting.

Quality Systems
To satisfy regulatory requirements, companies must design their systems to encompass a myriad of areas that include Corrective Action/Preventative Action (CAPA) programs, management review, production and process controls. Medical device manufacturers that have implemented a robust CAPA program are more likely to be successful in audits by regulatory authorities.

In addition to CAPA, document management system also plays a critical role in any quality system. For example, if there is a need for a document change as part of a corrective action, an ability to automatically trigger the document management system from the CAPA system for change management can significantly reduce errors and ensure that change corrective action was successfully implemented. Typical document management capabilities include managing the approval life cycle of the document, up versioning and obsolescing of the documents, ensuring that only the latest approved version of the document is visible to the users, version control, maintenance of document change history, safe storage of documents and appropriate access controls. In a FDA regulated environment, document management systems can help manage documents pertaining to key areas like manufacturing, design, process control, customer complaints, deviations, risk management, etc..

As the industry becomes increasingly global, quality systems will have to adapt to changes brought about by globalization. Third-party certifications based on a comprehensive quality system standard, for example, bring the industry a step closer to global harmonization as companies in the future adhere to possibly one global quality standard accepted by a number of regulatory bodies.

Getting off the ground with the new breed
The first step in getting off the ground is to employ the use of an automated compliance and quality management system. Such systems help to automate business processes, achieve consistency in process and also eliminate inefficient paper-based procedures. The new breed of automated systems clearly bring great benefits, not only in terms of cost savings but also in terms of product safety, effectiveness and all round visibility into internal controls (record keeping, documentation, and authorization) and quality assurance as stipulated by Part 11 and Part 820. These new breed of systems are typically web-based that allows authorized remote access, easy integration to other 3rd party applications for interaction between each other, validates the data provided by the user wherever required, and are configurable to meet certain organization specific requirements. The total cost of ownership of implementing such solutions is lower than quantifiable the overall benefits that accrue out of implementing them, thereby justifying the investment.

Enterprise-wide Systems
The new breed of systems enable an enterprise-wide visibility and control of quality management processes, as well as, regulatory compliance (FDA 21 CFR Part11, TREAD), industry mandate compliance (TS 16949, QS 9000:2002 etc.), safety compliance (OSHA, EPA & HAZMAT etc.), security compliance (Homeland Security, Government agency approvals etc.), internal policy compliance (ISO9000, branding policies etc.) and Sarbanes-Oxley compliance (Sox 302, 404 etc.).

These systems serve as a single system of record for all the compliance and quality data within an organization, as well as, all related tasks, activities and action items. As a result, manufacturers also gain an aggregated view of status of various activities across various processes, divisions, suppliers and customers, as well as, an assessment of overall risk associated with compliance through a common dashboard.

Integrate and Interact
Automated systems allow for better interaction and usability in terms of ease of use, and integration between disparate systems to improve overall efficiency. As standards get more stringent, quality, regulatory, document control, and supply-chain management systems need to be more flexible throughout the process and be able to interface with one another more effectively.

Quality systems must effectively integrate across the manufacturing facility - manage the process of handling non-conformance, CAPA, customer complaints, safety issues, supplier quality, audits, and other related reports while integrating with document control systems, supply-chain management systems, ERP systems, business intelligence systems, and MES systems. A single repository (server) could be set up at the manufacturers' corporate headquarters, and all its plants around the world can access the same information.

Web-based
In the regulated environment a web-based system is better suited for interface since it enables records relevant to multiple sites to be stored on one central repository (server) and users remotely access the system from different sites. Having a single common software system will also help in simplifying the software validation process. This becomes an important factor for manufacturers since it reduces validation costs, development time and becomes easier to maintain over the long run.

Configurable
The new breed of systems allow for configuration versus customization. Customizing involves making changes to the software, often having to hire someone to do so and typically resulting in project delays, additional testing and validation costs, and maintenance costs that are a nightmare. In a configurable environment , the software is programmed in such a way that an organization's specific need can be addressed by selecting the right kind of system parameters that determine the process routing and logic, list of values, properties, etc. This could be done by the organization's system administrators themselves, without the need for a code change. The strength of these new systems is that they allow administrators to configure the workflow to the way they do business, thereby mapping the entire process. An enhanced level of configuration will also reduce the implementation lead time thereby reducing the deployment costs drastically. This could be achieved easily with a few days of training on the system configuration capabilities and since it's already out of the box, making it faster and more cost-effective. In addition, a configurable system can significantly reduce validation costs.

Return-On-Investment
Global compliance and quality management systems and processes are critical for manufacturers competing in the FDA-Regulated industries. Manufacturers face the dual pressures of stringent and increasing regulatory pressure, and the need to streamline internal operations and supply chain interactions to eliminate non-value-added costs. Under these circumstances, the total cost of ownership and ROI become important elements for manufacturers in deciding on the solution they would like to implement in their organization.

The new breed of systems allows manufacturers to improve or streamline their manufacturing and quality processes, eliminate inefficiencies and thereby improve scalability in their operations. These systems provide clear visibility to their operations by means of appropriate metrics and dashboards. These metrics and dashboards also provide a quick insight into the actual improvement that has taken place as a result of the system implementation.

Medical Device Manufacturers can reap the benefits of -

  • Ensured compliance with 21 CFR Part 11 requirements
  • Reduced cost of compliance by automating compliance and quality management tasks
  • Reduced exposure to product recalls and associated costs