Pharmaceutical GxP Process Automation Software Solutions
Software to Help Pharmaceutical Companies Automate Paper-based GxP Processes to Improve Operation Efficiency, Accelerate Time to Market, and Ensure FDA Compliance
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For pharmaceutical companies, the process of introducing new medicines involves several internal departments working with external stakeholders in a highly regulated environment. Lead development produces volumes of scientific research that will produce only a handful of compelling new innovations for potential development. Once scientific and business evaluations are completed, these innovations will advance through regulatory processes such as the IND, dose ranging studies, human clinical trials, and the eCTD, going on to be manufactured in facilities using processes that meet FDA guidelines and standards. Early document management vigilance can improve workflow, maintain project timelines, and provide greater collaboration throughout the various phases of development and commercialization that support corporate strategic lifecycle and market decisions.
MasterControl automated process management and document management systems provide access of information to cross-functional teams. The system provides instant email messaging, revision draft vaults, and encrypted password protection. Tem members, managers, and senior managers can access important product documents in real-time and work accurately, efficiently and collaboratively to support company speed-to-market milestones.
Pharmaceutical GxP Process Automation
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)
