This solution is specifically designed to help pharmaceutical and biotech companies manage all their documents and automate all their regulatory-related processes, as well as employee training, via a single, Web-based platform. The software facilitates document creation using company-approved, best practice templates for every type of document a company uses, including clinical trial documents. Comprehensive project planning and management software automates task assignment, routing, escalation, and tracking, while speeding up a company’s processes, avoiding potential bottlenecks, and increasing management oversight. Collaboration workspaces can accommodate multiple departments and corporate sites, outside suppliers, consultants, etc. To facilitate continuous supplier monitoring and assessment, the TotalPharma solution provides a simple dashboard-like interface for all supplier-related quality information.
E-mail import functionality allows users to link related documentation to critical correspondence with regulatory authorities, CROs, or suppliers, so that everything can be tracked together. In addition, the solution offers MS Word 2007 integration, automatic creation of PDF renditions with appropriate bookmarks and e-signature manifests. Optional connectors to submissions publishing tools, scanning tools, and other commonly used enterprise applications such as SharePoint provide additional benefits.
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This Web-based solution dramatically decreases the time spent locating/managing critical documents during the R&D phase of a pharmaceutical or biotech company. Other benefits include preconfigured templates and routes for ensuring that documents are created, reviewed, and approved correctly the first time; state-of-the-art benefits also include cross-functional team collaboration, project management software, and automated training on approved changes to documents. The solution also incorporates MS Word 2007 integration, automatic creation of PDF renditions with appropriate bookmarks and e-signature manifests, and an out-of-the-box, best practices configuration for clinical trial documentation which minimizes configuration time and makes it possible to move to production faster.
This solution efficiently manages the continual changes to engineering designs and product specs. It also gets manufacturing, marketing, quality, and regulatory personnel involved early in the development cycle to maximize the likelihood of product success. The Web-based document management software allows design engineers to collaborate in their native CAD environments and manages updates to the DHF. MasterControl ENG also provides validation software, in addition to software for project management, BOM and supplier management.
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MasterControl Documents assigns a unique identifier to each document, and automates the routing, delivery, escalation, and approval of documents. The software solution can handle all types of documents regardless of the software used to create them. MasterControl features a centralized, secure repository that makes search and retrieval easy during inspections and audits. The software solution’s Web-based platform provides access to authorized users from any physical location.
In addition, MasterControl Documents provides a virtual workspace for collaboration. The software allows one authorized user at a time to revise a document to avoid the confusion of multiple document revisions. Because the software is Web-based, team members can review, comment on, revise, or approve a document without having to be physically present with the rest of the team.
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This solution is designed for companies that want to implement a complete document management/document control solution in preparation for a regulatory submission. The software provides submission-related document templates, as well as preconfigured document types specific to a company’s submission. Collaboration functionality and MS Word integration enable cross functional teams to collaborate on submissions documents, while ensuring their reliability and security.
The Submissions Gateway software (see page 12) provides a simple mechanism for creating copies of approved submission documents in the desired folder structure to share with a submission publishing group or contractor.
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MasterControl Analytics is an easy-to-use software application that enables non-technical users to develop sophisticated, customized reports. Once the report template is created, the user’s work is done. Because the Analytics application is connected with the rest of the MasterControl system, data from other areas (for example, CAPA, Audit, Employee Training, etc.) are automatically retrieved, analyzed and reported on in real time.
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MasterControl Process expedites forms-based processes, and controls the user’s ability to launch processes (based on his or her rights). This expedites processes and saves time and money, while reducing the potential for making mistakes. Configurable workflows automate routing to appropriate participants and can escalate tasks if timelines are not met. Tasks can be processed concurrently by multiple users or even groups. These features greatly speed up turnaround time.
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With MasterControl Supplier, all supplier status and quality information (such as non-conforming material reports) is contained in a single, easy-to-access location. In addition to providing an easily maintainable AVL, the Web-based solution features a user-friendly interface for accessing all documentation and records related to each supplier.
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Documenting training is critical for any regulated company. MasterControl automates the routing, tracking, documentation, training and retraining of training tasks. Whenever there’s a change in an SOP or other document linked to a course, all affected employees automatically receive new training tasks and notification via their email. Users are provided with training materials within the training tasks and their competency in relation to those materials can be documented through use of the Exam add-on. Configurable training reports show pending, past due and completed training, plus other critical information.
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MasterControl QAAD provides comprehensive, user-configurable and validated, off-the-shelf software for scheduling, managing, and reporting on audits, as well as responses to audit findings, CAPAs, and other QA activities. QAAD is used by more than 50% of the top 20 pharmaceutical companies, and is designed to be used by quality groups in any industry.
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