Pharmaceutical Labeling and Promotion Process Automation
Software to Automate the Labeling and Promotion Process for Pharmaceutical Products
If done properly, labeling begins at the earliest stages of development, as soon as the results from market analysis and expected scientific outcomes become available. As product development advances and the regulatory team begins preparation of the FDA submission, the Sales and Marketing team should begin preparing promotional materials for DDMAC review, to be delivered once FDA approvable is received. All promotional materials, including the product label, are scrutinized by the regulatory department, research development, legal, and often senior management. Revisions are frequently requested and readdressing data is common.
MasterControl can help automate the process of collaboration and redlining of promotional documents, and, once a decision is a made, obtaining the necessary approvals to move the promotional documents from their virtual "draft" vault into a virtual "release/approved" vault.
Pharmaceutical GxP Process Automation
MasterControl automates pharmaceutical GxP processes to improve efficiency and speed time to market. Processes include:
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.
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 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:
How MasterControl Makes Your Job Easier (3:50)
