MasterControl Organizer Gateway
The FDA's 21 CFR Part 11 allows regulatory information to be signed and submitted electronically and permits the use of electronic record-keeping systems in complying with predicate rules. While automated submission tools can cut costs and save time, they can only be as useful as the submission's content will allow. A submission tool is an advantageous conduit in the submissions process, but just as crucial is a mechanism that can ensure controlled, quality content in the regulatory submission.
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MasterControl's Organizer Gateway Is the Right Submissions Tool for Your Company
To guarantee submission consistency, companies in regulated environments demand that quality initiatives be integrated into the corporate culture organization-wide. The MasterControl Organizer Gateway™ responds to those demands by ensuring control in assembling and tracking documentation vital to submissions. It is an out-of-the-box application that can be integrated with leading e-submission tools, connecting approved documents and forms-based content with the submission assembly process, to accelerate the submission process. The enhanced Organizer Gateway is specifically designed to help companies meet the requirements for good document control within the confines of FDA-regulated GxP environments, including compliance with 21 CFR Part 11.
Any company preparing a submission will use its submission tool of choice, but it still requires an effective means of controlling documents and maintaining shared submission-related files in a secure submission repository. MasterControl provides a centralized repository that controls the creation, sharing, and documentation of submission-related files, regardless of the submission tool in use.
Features and Benefits of the MasterControl Organizer Gateway:
- Interfaces with Any Publishing System: Since custom connectors are not required, the Organizer Gateway will work with any publishing system, present and future. The initial collection and organization of documents within the Gateway followed by the export to the submissions publishing tool connects the document review and approval process with the dossier assembly process, accelerating the submission process.
- Integration with Submissions Locker: The enhanced Organizer Gateway is designed to work in conjunction with the MasterControl Submissions Locker to allow early stage organization of submissions documents in "pre-publishing" settings. The two solutions working together insure that documents are always up to date and maintained in a controlled central repository.
- Enterprise-wide Collaboration: MasterControl provides a truly enterprise level collaboration tool which allows diverse teams of users to work together to revise documents. Redlines of documents are stored for all team members to review, update or eventually upload as the final copy. Different teams can be included on sequential collaboration steps to promote faster and easier updates to the submission documents.
- Lifecycle Management: MasterControl provides complete lifecycle management, from document creation to submission, with the help of the following tools:
- MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Users can arrange files in Organizers and later export them to the directory structure of a particular submission. This avoids the extra step of integration. Updating files is easy because system administrators can create virtual folders within Organizers that automatically retrieve documents based on a pre-defined query.
- The InfoCard is a MasterControl tool that provides basic information about a document and serves as a placeholder for a file in the database. To modify a document, the InfoCard requires a user to enter a reason. Through the InfoCard, MasterControl then tracks document changes and provides a secure, time-stamped audit trail as required by 21 CFR Part 11.
- Publishing Control: The Organizer Gateway in combination with the Submissions Locker controls the submission before, during and after publishing, assuring all departments with confidence in the submission. After the initial export, the submission always contains the most current approved documents. When publishing is complete, the submission becomes a locked, read-only document in a repository controlled by the Submissions Locker. MasterControl allows the publishing team to focus on publishingâ€”not chasing down documents - which results in faster submission times.
- Submissions Export Utility: Copies submission documents and folder structure to the Submissions Locker and maintains an index of the documents. As documents are approved in MasterControl, they are automatically copied to the Submissions Locker. If a document is revised at the last minute, the updated approved version is immediately exported to the Locker. Not only does the Organizer Gateway have the capability to export to the Submissions Locker but it can export to a file share as well. In addition, updates to the Submissions Locker can be set according to a user-defined schedule and attachments may be included when documents are exported. Users may choose to export all documents or only those that have been approved.
- FDA Submission Templates: MasterControl provides appropriate templates (i.e., NDA, BLA, CTD, IND) to facilitate the dossier-creation process. Users are given the capability to manage, view, create, delete, and preview submissions templates. The Manage Submissions Template Right grants users access to the submission templates, which are in XML format. Templates created by a user - as well as MasterControl's pre-existing templates - appear in the Submission Templates drop-down list of the Gateway tab of an Organizer where they are available for use.
- Automated PDF File Generation: To make an electronic submission to the FDA, the agency requires that electronic files of regulatory information be submitted in PDF format. MasterControl offers automated PDF conversion of documents, including TOC level bookmarks, streamlining the process by not having to manually generate or edit the PDF files. Submissions are simplified since the amount of manual effort involved is reduced.
- Electronic Sig-offs: Signature manifestation (name, date, time, and meaning of electronic signature) can be appended automatically to each document as required by 21 CFR Part 11. The e-signature can be configured to include a user's title and the route step name in the manifest to distinguish the different kinds of approval a document receives (i.e., format approval made by a document control specialist vs. procedure approval made by the medical director).
- Signature Manifest Option: The Include Signature Manifest function allows users to include or exclude the signature manifest on documents that will be exported using the Organizer Gateway, providing a more efficient means of removing unneeded pages from documents when signature manifests are not required.
- Export File Names: The Export File Naming Convention gives users the ability to select a naming format via the Organizer Gateway. Users can choose one of several configurations of title, document number, and revision.
- Part 11-Compliant Features: In addition to e-signature, MasterControl provides other capabilities that fully satisfy FDA's 21 CFR Part 11 requirements, such as a time-stamped audit trail that can be linked to the approval process. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.
- Web-based Platform: MasterControl's platform is Web-based so it can connect employees, consultants, and others involved in submissions regardless of location.
MasterControl Helps Companies Overcome Common Submissions Challenges
Here's how MasterControl addresses key submission preparation obstacles:
FDA submissions (e.g., for a NDA or IND) can entail thousands of pages that need to be managed, compiled, published, and revised. With a paper-based system, the process can be overwhelming and is prone to error and delay.
MasterControl's centralized repository for all regulatory submission documents makes search and retrieval easy. A single repository also simplifies follow-up submissions and reduces potential agency questions. MasterControl integrates with a company's existing submission tool to streamline and optimize the e-submission process.
|Lack of Security
Paper submissions compiled in binders and folders or stored partially in computers provide little security and might not be able to guarantee data integrity. Submissions documents stored on file shares provide only slightly more control. Submission documents in these circumstances may be "uncontrolled" during the entire process.
MasterControl controls submission documents before, during and after publishing. Documents are stored in secure virtual vaults located in a central database for authorized access only. The system uses industry-standard SSL and 128-bit encryption capabilities to secure data communications that take place between the Web browser and the application.
|Lack of Revision Control
In a paper-based or simple file share based system, there could be multiple (unwanted) versions of documents. Modifying a document entails time-consuming meetings and manual change.
|Automatic Revision Control
MasterControl provides automatic revision control to insure that only the most current version of a document is available, so users will not make the mistake of working with unapproved or obsolete documents.
For More Information about MasterControl Organizer Gateway
For more information on how MasterControl Organizer Gateway, please feel free to contact a MasterControl representative.
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