QSR Software Solutions for Medical Device Manufacturers
21 CFR Part 11 Compliant Software to Automate Quality Systems Outlined in FDA's 21 CFR Part 820 Quality System Regulation (QSR)
More than 20,000 companies worldwide produce over 80,000 brands and models of medical devices for the U.S. market. A company's success in this highly competitive and dynamic market depends on continuous innovation, rapid product development, and the ability to respond to market needs in a cost-effective and clinically relevant manner. The medical device industry, among the most heavily regulated industries today, must also contend with stringent regulations in order to stay in business.
The Food and Drug Administration (FDA) regulates the medical device industry based on a host of regulations, including the Quality System Regulation outlined in 21 CFR Part 820, Current Good Manufacturing Practices (CGMP). Companies that maintain electronic record-keeping systems are covered by 21 CFR Part 11. Many medical device manufacturers, especially those that sell products overseas, also conform to ISO13485 (?Medical Devices ? Quality Management System ? Requirements for Regulatory Purposes?), ISO 14971 (?Medical Devices - Application of Risk Management to Medical Devices?), and ISO 9000 quality standards. Public companies or those planning to go public or are acquired by public companies are covered by Sarbanes-Oxley Act (SOX) requirements.
A medical device company's ultimate goal is to produce a safe, reliable, and effective product. To achieve this goal, the company must address many challenges including:
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Inefficient Quality System: Companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs, DHF, DMR, and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during FDA inspections.
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Disconnected Processes: Quality processes that are not connected to each other can cause delays and poor results. For example, a change control process that's not connected to customer complaint, CAPA, training, and other quality processes is likely to cause delays in change implementation. A CAPA process that's not connected to the rest of the quality system may produce an unreliable root cause investigation due to inadequate information.
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High Cost of Validation: 21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a medical device company successfully automates its manual record-keeping system, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost.
Compliance is a state, not an event. A medical device company must not only attain compliance, but sustain it year after year. The MasterControl? integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance with FDA and other regulations by automating and managing quality processes in an efficient and cost-effective manner.
Recognizing that validating a software solution ? and keeping it in a constant state of validation ? is half the battle in sustaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
Roll over the list of solution categories below to view the related MasterControl product, then click to go to that solution's product page.
MasterControl Documents™ helps increase the efficiency and effectiveness of each department by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation, making search and retrieval easy.
MasterControl Change Control™ streamlines the entire
change control procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change implies great impact on the product and is likely to require regulatory filing. Customizable reports provide real-time status not only of
change control tasks but of the entire quality system.
The MasterControl CAPA™ solution interconnects different quality subsystems and tracks incidents that can escalate into a corrective action. It includes a best-practice "8D" process to guide the quality team through every step of CAPA implementation, from identification of the problem through corrective action. A CAPA form can be launched directly from another form (e.g., nonconformance or deviation report), automatically entering relevant data into the CAPA form, reducing data entry and eliminating errors from manual transfer of information. Through the Internet, customers, vendors, and others outside the company can submit customer complaint or other forms that could lead to CAPA.
MasterControl Training™ automates assignment and monitoring of training tasks and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed, the next one is automatically launched. Provides group sign-off feature for verifying training of large groups of employees. Training control can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.
MasterControl QAAD™ audit management software automates, streamlines, and effectively manages the audit process. It provides advanced tracking capability, from scheduling and planning to execution and completion. MasterControl offers best-practice forms for tracking basic audit information and audit findings. It automates scheduling of all recurring audit-related activities and provides advanced analytics and reporting capability, so managers get a real-time view of the audit process.
MasterControl Submissions™ facilitates electronic delivery of FDA applications (such as IND, NDA, and BLA) by providing control in assembling and tracking necessary documentation. It provides appropriate templates to streamline the dossier-creation process. MasterControl can be integrated with leading e-submission applications, connecting approved documents and forms-based content with the dossier assembly process, to accelerate submissions.
MasterControl Customer Complaints™ streamlines the complaint-handling process and reduce the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with a resolution of the issue. MasterControl's advanced reporting capabilities increase management oversight and demonstrate appropriate controls to regulatory agencies. MasterControl is Web-based, so customers can submit complaints from virtually anywhere.
The FDA's 21 CFR Part 11 requires full-cycle validation of electronic record-keeping systems to assure the accuracy, reliability, and consistent intended performance of the system. MasterControl provides comprehensive validation services, including onsite IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) tests to ensure that the system is fully compliant. For companies wanting to perform their own validation, MasterControl offers a Validation ToolKit, which provides a detailed, pre-written validation test protocols and scripts.
MasterControl eMDR™ helps medical device companies electronically automate their adverse event reporting process in the confines of FDA/GxP environments including compliance with 21 CFR Part 11.
MasterControl DHF JumpStart™ helps medical device companies organize the myriad of drawings, notes, collaborative pieces,reports, and other documents that are created during the design process. Device companies want a tool that bridges the gap between design and manufacturing and provides project management, design control processes, and document control and approval. MasterControl DHF JumpStart meets their desires, point for point.
MasterControl Bill of Materials™ (BOM) streamlines the handling of BOMs and helps companies overcome common BOM-related predicaments.
MasterControl Supplier™ software system to automate supplier management and supplier compliance in FDA and other manufacturing environments.
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