The submission process begins with early stage discovery research and the subsequent IND. Building on this initial scientific data and FDA authorization, the dose-ranging study, human trials, and a pharmacoeconomic study follow. Results from these studies, as well as CMC manufacturing and quality processes, and any studies that have been done by external research organizations, are combined into the NDA. If documents have not been organized and stored within a secure document management system, the data that must be complied, reviewed, and organized can become a labyrinth of confusion and revision. The sheer volume of data and reports from CROs and Principal Investigators that must be reviewed in order to develop a meaningful regulatory strategy for securing approval makes it easy to miss important information.
How Can MasterControl Software Solutions Help Pharmaceutical Companies Automate Processes to Accelerate Submissions
MasterControl collaboration and document approval software can help organize and manage the study data and results as they come in, enabling the submission to be developed in parallel with the studies. MasterControl also provides out-of-the-box solutions to help paper-based companies organize the necessary documents required for FDA approval.
MasterControl automates pharmaceutical GxP processes to improve efficiency and speed time to market. Processes include:
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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.
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: