Pipeline RA Provides Document Control Solutions for Regulatory Affairs
We don’t have a system for managing our submission-specific documents
Pipeline RA is a powerful tool for managing submission-specific documentation. Pipeline RA is designed to streamline the document management and electronic submissions. All content related to submissions is controlled by Pipeline RA providing a safe repository and easy access for content and content re-use.
Our submission management system should be 21 CFR Part 11 compliant
Pipeline RA’s validated document management and electronic publishing system solution helps streamline document management. Fully compliant with CFR 21 Part 11 you get all the benefits of electronic document control while confidently maintaining regulatory compliance. Validation occurs prior to every release of Pipeline RA ensuring that the software and systems operate in a continual validated state. Moonbay Technology lets you attain and uphold regulatory quality and compliance.
We don’t have the resources to configure our Submission Management System
Pipeline RA has preconfigured document types based on the CTD format for efficient electronic submissions. Pipeline RA is also equipped with other document types typically used in organizations. In addition to the preconfigured document types, Pipeline RA provides flexibility to modify or add document types. If you are implementing another document management system, Moonbay Technology Services can set up personalized workshops for you to ensure that your document management system is properly configured and based on industry standards.
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