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Traditional document management systems (DMS) require significant IT infrastructure, support and ongoing maintenance which are often cost- prohibitive for smaller and emerging biotech and pharmaceutical (pharma) organizations. Another challenge for growing organizations is that document management systems require validation programs and must be 21 CFR Part 11 compliant – often requiring substantial business resources and time. When considering the complex components, resources and tasks required to effectively manage submissions, document management systems can seem out of reach.
Growing biotech and pharma companies no longer need to compromise their expectations of document management systems. Octagon’s Quantum™ Content Manager Module in a SaaS model (Software as a Service), provides these organizations with the robust DMS capabilities of large organizations without the burden of maintaining a complex IT infrastructure.
Quantum Content Manager is an easily scalable solution that provides growing organizations big-company DMS features and functions at a fraction of the cost. Since the Quantum Content Manager is offered in a SaaS model it reduces the burden on the IT organization. In addition, it is integrated with a CTD template suite, submission publishing capabilities, and submission management tools. It also offers optional built-in rendering capabilities to efficiently create an e-Submission- ready final document. Quantum was also developed to integrate with Octagon’s StartingPoint® eCTD document authoring template suite.
Quantum’s Content Manager Module puts big DMS capabilities in reach for growing organizations.
| Quantum Content Manager Business Capabilities | Advantage to Sponsors/Users |
| Out-of-the-box configuration | Pharma- biotech-focused and based on Octagon's submission and document management best practices |
| User-driven, flexible workflows match to any organization's business processes | Workflows can accommodate document review in Microsoft Word as well as PDF format Workflows account for quick batch approvals as well as eApproval and eSignature tasks |
| Robust search capabilities | Secure searching with sophisticated parsing, results clustering and ability to save searches for future reference |
| Ready to use folder structures, document types, and attributes | A complete taxonomy is provided. Easily create, find, and re-use your submission-bound content. |
| 21 CFR Part 11 compliant | Ensures all documents, records and approvals are submission compliant |
| SaaS model | No dedicated IT staff required for support and maintenance Low cost alternative as upgrades are included and there are no upgrade fees |
| 24x7 support desk | Provides the support needed to maintain system at peak efficiency in any time zone, 24x7 |
| Online tutorials | Minimizes effort and time required to train new staff or update existing staff |
| Validation included | Reduces burden of extra time and resources and ensures submission compliance |
For more information download a PDF of the Quantum Content Manager Data Sheet.
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