Medical Device Process Management and Document Management Software Solutions
MasterControl Automates GxP Processes from Product Concept to Market to Help Medical Device Companies Accelerate Time to Market and Ensure Compliance with 21 CFR Part 820 QSR, ISO 13485, and ISO 14971
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, one of the most heavily regulated industries in existence, must also contend with stringent GxP regulations in order to stay in business.
GxP Regulatory Requirements for Medical Device Companies
The Food and Drug Administration (FDA) regulates GxP processes in the medical device industry based on a plethora of regulations, including the Quality System Regulation (QSR) outlined in 21 CFR Part 820, Current Good Manufacturing Practices (CGMP). Companies that utilize electronic record-keeping systems must also maintain compliance with 21 CFR Part 11, which is predicated on FDA GxP requirements. Many medical device manufacturers, especially those that sell products overseas, must conform to ISO 13485 (“Medical Devices – Quality Management System – Requirements for Regulatory Purposes”), ISO 14971 (“Medical Devices - Application of Risk Management to Medical Devices”), and ISO 9000 standards. Public companies or those companies that are planning to go public or are acquired by public companies are subject to Sarbanes-Oxley Act (SOX) requirements as well. These are just a few of the GxP regulations that medical device developers must contend with as a product moves from development to commercialization.
Medical Device Product Development Challenges
A medical device company's ultimate goal is to produce a safe, reliable, and effective product in a timely manner while staying ahead of the competition and staying in compliance with GxP requirements. To achieve this goal, the company must address many challenges, including:
Inefficient, Paper-based Document Management Systems that Delay Time to Market: Companies with multiple facilities and employees in different locations may initially find it less expensive to maintain separate GxP systems. Typically, to keep costs down, these systems are paper-based or hybrid paper/electronic in their early phases. In the long term, however, these inefficient systems will require employees to devote an enormous amount of time to tasks that could be streamlined by an automated system, such as: 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.
Disconnected Quality Management Processes: GxP processes that are not connected to each other cause delays and adversely affect the device being developed. For example, a change control process that is not connected to customer complaint, CAPA, training, and other processes is likely to cause delays in change implementation. A CAPA process that is not connected to the rest of the system may produce an unreliable root cause investigation due to inadequate information availability.
High Cost of Validation: 21 CFR Part 11 requires computer system validation as a means of protecting the integrity of electronic records and signatures. Even if a medical device company successfully automates its paper-based systems, it still faces the daunting work and high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance costs.
MasterControl GxP Process Management Software Solutions
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 process management and document management suite is a configurable, easy-to-use solution that helps companies attain and maintain compliance with FDA, ISO and other regulations by automating and managing GxP processes in an efficient and cost-effective manner. This connectivity helps improve communication between departments, promotes quality and compliance throughout the enterprise by allowing managers to continuously monitor and proactively improve all GxP processes throughout the entire product development lifecycle. Some of these key processes include:
MasterControl makes it possible for medical device developers to meet key GxP requirements and ISO standards while also increasing efficiency and keeping compliance costs down. MasterControl helps companies to recognize GxP compliance as a part of the corporate culture by enabling compliance to be enforced across the enterprise in every department. By connecting company personnel with relevant data and processes, everyone is able to see “the big picture.” The result is an environment that fosters collaboration and allows managers to visualize and monitor all product development processes as a unified system.
Recognizing that validating a software solution—and keeping the software in a continuous state of validation—is half the battle in maintaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system based on the risk of each individual company.
What Solutions Are You Looking For?
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 quality unit's efficiency and effectiveness 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 Documents, the core application in the MasterControl quality management suite, integrates all quality processes such as change control, customer complaints, corrective/preventive action, audits, etc., for a closed loop solution.
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.
The MasterControl Audit™ solution 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.
For companies seeking compliance with the Sarbanes-Oxley Act (SOX), the MasterControl SOX™ is a complete and easy-to-use solution that automates and effectively manages business processes, including voluminous documents, records, and SOPs. It includes a pre-configured form that documents and collects data pertaining to risks, internal controls, and tests. It links every risk with its control and test through pre-built workflows. It allows testing to be automatically scheduled and incorporates escalation to ensure that tests are completed.
For many small pharmaceutical and biotech companies, GCP stands for "Great Complicated Paperwork" rather than “Good Clinical Practices.� The voluminous paperwork is an integral part of meeting the international, ethical, and scientific quality standards for designing, conducting, recording and reporting trials that involve human subjects, but that doesn’t make it any easier to handle. Small contract research organizations (CROs) commonly feel overwhelmed by all the documentation required by the standard.
View 3 Minute Demo
View Customer Videos
Request Live Demo
View Newsletters
Download White Papers
Download Product Info
Industry-Related Events
