The move toward all-electronic submissions and the stringent FDA submission requirements pushes life sciences companies to adopt a disciplined approach toward the authoring and review of submissions documents. Companies that do not begin to create and publish submissions-ready documents in the early stages of the clinical study process will unquestionably face delays in the submissions process and possibly suffer adverse effects from delayed approval and potentially lose profits as products take longer to get to market.
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MasterControl Inc.’s Submissions Locker is an indispensable tool that can be utilized throughout a submission’s lifecycle. The Submissions Locker provides a secure environment that is accessible to any publishing tool preferred by the user. The Submissions Locker works in tandem with MasterControl’s enhanced Organizer Gateway to help users better prepare and control electronic submissions to regulatory agencies by supporting a full lifecycle for creating submissions.
The following are some examples of how MasterControl’s Submissions Locker addresses common challenges faced by companies preparing regulatory submissions.
|Submissions Management Challenges||MasterControl Submissions Locker Submissions Management Software Solution|
Publishing solution does not interface with document management system. Development of custom connectors takes time and resources.
MasterControl allows all publishing tools to access the Submissions Locker just as they would any ordinary file share. The Submissions Locker is secure and always up to date with the most current documents.
Disconnect between publishing solution and document management system can lead to inadvertent, "uncontrolled" sharing of submission document files. The result is wasted company time and manpower, diminished confidence in the submission's content, and the potential for document integrity to be compromised.
The Submissions Locker provides a secure, Web-based location where submission document access can be easily controlled. After authentication, MasterControl allows the publishing tool of choice to access the Submissions Locker as a standard file share. All access is controlled exclusively by MasterControl login parameters.
|Lack of Revision Control:
Documents are revised and approved at different times, sometimes at the last minute, which may require users to perform a manual export..
|Automatic Revision Control:
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 Submissions Locker.
To attempt to control file sharing between disconnected systems, IT departments must constantly respond to requests to alter share permissions during the publishing process, wasting personnel time and jeopardizing file share control.
MasterControl electronically controls and tracks access share rights, making the publishing process more efficient and reducing the imposition on IT departments. The submission is secured by MasterControl throughout the publishing process.
Early Stage Organization: The Submissions Locker works hand-in-hand with the MasterControl Organizer Gateway to permit pre-publishing organization and control of submissions documents. The two solutions working together streamline the document assembly and organization process starting at the beginning of the submissions cycle by insuring that documents are always up to date and maintained in a secure, centralized repository.
Uniformity: The Submissions Locker allows users to maintain documents in the same format in which submissions are sent to the FDA.
Version Control: MasterControl's Submissions Locker insures that users are always working with the most current document versions. All submissions are assigned unique numbers and associated with applicable parent-child relationships.
Security and Authorization: The Submissions Locker provides regulated companies with a secure location where submission document access can be readily controlled. Once it has been authenticated, MasterControl allows the user's publishing tool of choice to access the Submissions Locker just as it would any ordinary file share. Rights to access the folders are controlled automatically by MasterControl.
Revision Contorl: Approved versions of updated documents are automatically exported to the Submissions Locker. MasterControl insures that all revisions are linked to affiliated submission serial numbers.
Submission Assurance:The Submissions Locker, working in conjunction with MasterControl's Organizer Gateway, controls submissions before, during and after publishing, which ensures that all departments involved can have increased confidence in regulatory submissions.
Reduced IT Pains: Since file sharing rights are controlled automatically by MasterControl, IT departments won't have the hassle of constantly modifying access permissions throughout the submissions cycle.
No Custom Connectors Required: MasterControl’s Submissions Locker is publishing tool “agnostic” and can work with any publishing system preferred by the user, present and future.
Centralized and Secure System: With MasterControl, all essential submissions documentation can be imported into and maintained by a central, controlled repository. After being authenticated by MasterControl, the user's publishing tool of choice is able to access the Submissions Locker's secure environment.
Interoperability:The Submissions Locker and the enhanced Organizer Gateway function seamlessly with MasterControl's PDF Publishing solution to preserve record format, authenticity and integrity by providing PDF features (bookmarks, table of contents, etc.) that are crucial to streamlined submission processes and regulatory compliance. MasterControl's configurable settings allow users to match regulatory agency requirements. MasterControl alleviates the negative consequences frequently associated with uncontrolled documents by enabling the "self destruction" of electronic copies, stamping expiration times on printed copies, and embedding a list of all signatures to each document.
Compliance:MasterControl's Submissions Locker is designed to meet the requirements for appropriate document control according to GxP industry standards and regulatory guidelines, including compliance with the FDA's 21 CFR Part 11.