Medical Device Labeling and Promotion Process Automation
Software to Automate Quality System Processes and Ensure Medical Device Companies are in Compliance with CGMPs and 21 CFR Part 11, and Part 820.
The labeling and promotion of medical devices are tightly controlled by the various bodies that regulate these devices throughout the world. The FDA in particular is very stringent in its labeling and promotion requirements. A large percentage of medical device recalls are related to labeling issues and cost manufacturers millions of dollars per year. A tightly controlled, efficient process for the creation and maintenance of labeling and promotional items is an excellent way to ensure compliance and potentially save millions on costly recalls.
GxP Process Automation
MasterControl automates medical device GxP processes to improve efficiency and speed time to market. Processes include:
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.
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