NEWS - MASTERCONTROL SUBMISSIONS GATEWAY

Submissions Gateway™ Enhanced Solution Available from MasterControl

SALT LAKE CITY, UT, USA – February 5, 2008 – MasterControl Inc., a global leader in GxP process management solutions for the life sciences industry, today announced the release of its enhanced Submissions Gateway™ solution. MasterControl's Submissions Gateway allows companies doing business in regulated GxP environments to maintain control in assembling and tracking documentation vital to submissions. The enhanced Submissions Gateway is specifically designed to help companies to meet the requirements for good document control within the confines of FDA-regulated environments, including compliance with 21 CFR Part 11.

"The MasterControl Submissions Gateway solution provides a truly enterprise level collaboration tool that allows diverse teams of users to work together to revise documents," said Lane Hirning, MasterControl product manager, pharmaceutical industry expert. "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. The enhanced Submissions Gateway allows the regulatory group to organize and 'pre-publish' the approved submissions documents earlier in the process, reducing the time spent searching for and organizing documents as the time-critical submissions phase approaches."

The enhanced Submissions Gateway is designed to work in conjunction with the MasterControl Submissions Locker to allow early stage organization of submissions documents in a "pre-publishing" setting. The two solutions working together insure that documents are always up to date and maintained in a single controlled repository. MasterControl's Submissions Gateway solution will work with any publishing system-present and future-without requiring custom connectors.

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. The initial collection and organization of documents within the Submissions Gateway followed by the export to the submissions publishing tool connects document review and approval processes with the dossier assembly process, accelerating the overall development of the submission.

The Submissions Gateway, in combination with the Submissions Locker, controls the submission before, during and after publishing, which provides all departments with confidence in the submission's content. After the initial export, the submission always contains the most current approved documents. When publishing is complete, the submission documents become locked and read-only 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.

Together with the MasterControl Submissions Locker, MasterControl Submissions Gateway provides a single system in which to author, review, approve, PDF publish, organize and export all submissions documents, with the help of the following tools:

  • The Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Users can arrange files in a submissions folder structure configured within the Organizer and later export the document collection maintaining the directory structure of the 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 (metadata) 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 for the modification. Through the InfoCard, MasterControl then tracks document changes and provides a secure, time-stamped audit trail as required by 21 CFR Part 11.
  • The PDF Publishing engine preserves 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 PDF Publishing offers configurable settings that 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 and stamping expiration times on printed copies. The PDF Publishing solution meets FDA 21 CFR Part 11 requirements for signature manifestations by automatically embedding a list of all signatures to each document, helping FDA regulated companies to maintain compliance.
  • The Submissions Gateway incorporates a configurable export utility to copy submission documents and folder structure to a file share or the Submissions Locker and maintains an index of the documents. As documents are updated and approved in MasterControl, they are automatically and seamlessly exported to the submission assembly destination. Updates to the Submission via the export utility 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.

MasterControl makes it possible for signature manifestation (name, date, time, and meaning of electronic signature) to 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 versus procedure approval made by the medical director).

In addition to e-signature, MasterControl provides other capabilities that fully satisfy the FDA's 21 CFR Part 11 requirements, such as a time-stamped audit trail. The solution comes complete with appropriate FDA templates (i.e., NDA, BLA, CTD, IND) to facilitate the dossier-creation process.

Submission 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. Other pertinent security features of the MasterControl Submissions Gateway include: dual passwords for document approval; password expiration, encryption, and certification; and account lockout to prevent unauthorized users from gaining system access.

About MasterControl Inc.
MasterControl is a global provider of document management and GxP process solutions. MasterControl automates and effectively manages document control, change control, audits, corrective/preventive actions (CAPA), regulatory training, nonconformance disposition, customer complaints, and other GxP processes. The MasterControl solution is easy to use, easy to deploy, easy to validate, and easy to maintain. MasterControl incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance with requirements such as ISO standards and FDA regulations. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl reduces the total cost of ownership and enables customers to extend their investment across the enterprise. For more information, visit the MasterControl website or call toll free at 800-825-9117.