Content Management for Submission-Specific Documents
The Pipeline RA Content Management component features the ability to Control and Share regulatory documents, Develop products and provide a Quality function through smart workflows. When a document is marked as "final" in Pipeline RA, it is automatically converted to PDF, while maintaining the native version for future revisions.
Control
Version control/history and audit trails-Pipeline RA maintains version control and a version history and provides a clear and concise audit trail for all uploaded regulatory documents
Pre-defined document types-Pipeline RA includes pre-defined regulatory document types based on the CTD format
Cross-references-Pipeline RA has cross-referencing features for regulatory documents
Review Cycle-Pipeline RA review cycle is built into the upload process and can be implemented at any time during the document lifecycle
Electronic Signatures and Signature Pages-Pipeline RA enables electronic signatures and the ability to upload scanned signature pages
Message Board-Pipeline RA's Message Board system is used to notify users of actionable events across all modules in the Pipeline RA web and Pipeline RA notifications can be sent to your e-mail inbox
Reference Library-Pipeline RA's Reference Library is a central repository for all references related to material that goes into a submission with built in links for quick access and retrieval
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Share
Pipeline RA is based on the Software-as-a-Service (SaaS) model and our web-based regulatory software and document management provides secure portals that are quick and accessible for transferring and sharing information for due diligence, inspections or audits or for interface and collaboration with contractors, consultants, CROs and contract manufacturers
Viewing Room-Pipeline RA’s regulatory software includes a Viewing Room that provides a controlled and secure way to share specified documents with people who are outside of your organization. Multiple viewing rooms can be set up simultaneously and guests will only have access to the room that has been designated to them
Transfer Room-Pipeline RA’s regulatory software includes a Transfer Room that provides a controlled and secure way to exchange documents with people who are outside of your organization. Multiple viewing rooms can be set up simultaneously and guests will only have access to the room that has been designated to them
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Develop
Clinical Module-is a study management system for documents related to clinical regulatory studies and product development. Product lot numbers used for investigational products can be tracked in the Clinical regulatory module
Safety module-manages all documentation related to drug safety reporting and safety tables and listings. An expedited tracking workflow manages safety reports over the 7 or 15-day reporting window to ensure compliance with timed reporting requirements
Nonclinical module-is a study and document management system for all nonclinical studies and summaries. Drug product or study compound lot numbers used for nonclinical studies can be tracked in the Nonclinical Module
Regulatory CMC-module serves as a controlled document repository for all data and documentation related to drug substance and drug product manufacturing and controls and batch records. The management tools allow you to track deviations and discrepancies in relation to batch records and manage drug shipments
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Quality
The Regulatory Quality module provides web document management and workflows for the Regulatory Quality Assurance.
Controlled documents-The Regulatory Quality module serves as a document management system for controlled documents
Training Management-Training can be set up, managed and tracked in the Regulatory Quality module. SOP and group trainings can be scheduled and tracked for users in the system. Those with access to Pipeline RA will be able to view their training records
Equipment Tracking-Information for equipment validation can be uploaded, managed and tracked in the Regulatory Quality module. Logbooks are built in and record use, maintenance, calibration and cleaning. Issues that arise from equipment use can monitored through the CAPA function
Audit Workflows-Audits may be scheduled and tracked in the Regulatory Quality module. Audit-related documents can be uploaded, managed and tracked
CAPA (Corrective and Preventive Action) Workflows- CAPAs can be entered into the Regulatory Quality module and tracked. Documentation related to CAPAs may be uploaded and tracked
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