Scientists and researchers develop new chemical and biologic entities through a lengthy process of trial and error. Knowledge, experience and the data that come from this process can enhance new products, pipelines, and therapeutic area franchise opportunities. Collaboration and review enhances the team’s ability to develop chemical and biologic formulations efficiently and effectively, but meetings and data review can also take a great deal of time away from moving new compounds forward. The leads that are selected as candidates are further researched for relevance; both scientifically and fiscally. Decision making on the advancement of lead development involve a cross-functional team of research development, manufacturing, and business analysis, which generate reports and scenarios for senior management. The scientific study done in the lead refinement process zbecome both new patents for the company and the IND filing with the FDA; critical processes that must be complete and accurate.
How Can MasterControl Help Automate Your Lead Refinement Process?
MasterControl can help companies meet milestones, while maintaining document accuracy through software solutions developed specifically for the life science industry. Cross-functional teams can share data, while allowing workflow processes to be heightened based on the ability to move forward without interruption and informed accuracy.
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 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)
