Electronic Submissions / Regulatory Submissions Software - Features & Benefits

eSubmissions Software to Automate Electronic Regulatory Submissions in an Efficient and Compliant Manner

Most regulatory bodies around the world allow companies to submit regulatory information electronically and to use electronic record-keeping systems in complying with predicate rules.

How can MasterControl Submission Gateway™ Benefit You?

MasterControl Submissions Gateway™ facilitates electronic delivery of FDA submissions by providing control in assembling and tracking necessary documentation. Here's a glance at some key challenges faced by companies in preparing their FDA submissions:

Free Downloads
	Product Data Sheet: MasterControl Submissions Ready™
	Product Data Sheet: MasterControl Submissions Gateway™
	Product Data Sheet: MasterControl Submissions Locker™
	White Paper: Managing the Document Lifecycle from Creation to eSubmission and Beyond
	White Paper: FDA Experts Offer Top Tips to Optimize Your eCTD Submission

Watch Videos: Learn More How MasterControl Makes Your Job Easier (3:50) Creating a Paperless Process Using MasterControl (3:38)

Regulatory Submissions Challenges		MasterControl Submissions Gateway™ Solution
Inefficient Processes Regulatory submissions (i.e., for a new drug or investigational drug application) can entail thousands of pages that need to be managed, compiled, published, and revised when necessary. With a paper-based system, the process can be overwhelming and is likely to cause delays and errors.		Efficient Process MasterControl can be integrated with a company's existing submission tool to streamline and effectively manage the process of electronic submission. MasterControl provides a centralized repository for all regulatory submissions, making search and retrieval easy. MasterControl is Web-based so it's accessible to all authorized users regardless of location.
Lack of Security 21 CFR Part 11 has specific security requirements to ensure the integrity and authenticity of data. Paper submissions compiled in binders and folders or stored partially in computers provide little security.		Secure Repository Documents are stored in secure virtual vaults located in a central database for authorized access only. Automatically locks both login and approval any time a password or login is compromised. 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 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.

Features

Here's a summary of MasterControl Submissions Gateway's features:

Interfaces with Any Publishing System - Since custom connectors are not required, the Submissions 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.

Integrates with Submissions Locker - The enhanced Submissions 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 compile 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 and other regulations.

Publishing Control - The Submissions 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 publishing—not chasing down documents—resulting in faster submission times.

The 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 Submissions 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 streamline 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, or other regulatory agencies, files should be submitted in PDF format. MasterControl offers automated PDF conversion of documents, streamlining the process by not having to manually generate PDF files. The unalterable PDF format also provides added security and control.

Electronic Sign-offs - With MasterControl, documents can be signed and approved electronically. Signature manifestation - name, date, time, and meaning of electronic signature - can be appended automatically to each document as required by 21 CFR Part 11 and other regulations.

Submissions Export Utility - MasterControl's 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 Submissions 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.

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 Submissions 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 Submissions 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.

Continuous Validation - MasterControl offers a "continuous validation" approach that dramatically cuts the time, pain, and cost involved in validation. MasterControl's continuum of innovative products and services, including MasterControl Transfer OQ, insure companies go-live faster and more cost effectively.

Web-based Platform - MasterControl's platform is Web-based so it can connect employees, consultants, and others involved in submissions regardless of location.

Product Training - MasterControl's Professional Services team, consisting of former ISO auditors and system administrators, has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI more rapidly. The team conducts training at MasterControl's state-of-the-art Training Center in Salt Lake City or on-site at the customers' facilities.

Technical Support - Choosing MasterControl means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer's needs, from initial installation to regular maintenance.