The company that files the IND is wholly responsible for product outcomes and FDA compliance until that product is no longer on the market or the company is acquired. FDA compliance, with respect to regulatory filing activities as well as development and manufacturing, is under the jurisdiction of specific GxP mandates. The technical, review, and collaborative aspects of FDA compliance can be very involved and expensive. Costs increase significantly when companies use external contract laboratory and manufacturing organizations. All processes and templates must be agreed upon in initial build out or contracting. If manufacturing is housed in a separate facility or global locale, communication can become difficult due to time zones and foreign languages.
With so much riding on the ability to maintain compliance, MasterConrol software for managing quality control processes such as nonconformances, CAPAs, customer complaints, change control, and training?only makes sense.
MasterControl automates pharmaceutical GxP processes to improve efficiency and speed time to market. Processes include:
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.
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 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.
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 GCPDocs JumpStart™ provides a solution for collecting, organizing, and reviewing all the documents required to meet GCP requirements.
MasterControl Supplier™ gives companies the capability to efficiently manage and approve vendor lists and effectively track supplier quality and supplier status.
MasterControl QAAD™ audit management software is the only off-the-shelf quality management solution that has been specifically developed for pharmaceutical quality groups.
MasterControl Batch Records™ is a powerful EBR management solution for automating and controlling batch processes. This automated EBR system will help ensure GMP compliance and increase efficiency in creating and managing master recipes and control recipes. For manufacturers automating their paper-based batch record systems for the first time, MasterControl meets all software-related requirements of Part 11.
MasterControl CAPA™ is a robust, easy-to-use system designed to effectively manage the corrective action / preventive action process and integrate it with other processes critical to regulatory compliance, such as change control, audit, and customer complaints. Here's how MasterControl CAPA addresses some of the major challenges that companies face in establishing and maintaining effective corrective and preventive action processes:
MasterControl Inc. und sein Partner i4DM erweitern ihr FDA-Projekt und wollen als QMS-Anbieter für einen zweiten FDA-Bereich fungieren. Die beiden Unternehmen sind seit 2009 als QMS-Anbieter für das Office of Regulatory Affairs der FDA tätig.
Nun werden sie auch als Qualitätsanbieter für die Division of Pharmaceutical Analysis fungieren, die Teil des Center for Drug Evaluation and Research der FDA ist.