Software is specifically designed to help companies meet the requirements for good document control according to GxP industry standards and regulatory guidelines, including 21 CFR Part 11 compliance
MasterControl, a provider of GxP process management for the life sciences industry, has announced the release of the Submissions Locker software.
The Submissions Locker provides a secure MasterControl environment that is accessible to any publishing tool preferred by the user.
The Submissions Locker works in tandem with MasterControl's enhanced Submissions Gateway to help companies doing business in regulated environments to better prepare and control electronic submissions to regulatory agencies by supporting a full lifecycle for creating submissions.
"The MasterControl Submissions Locker insures that regulatory users are always working with the most current version of a document," said Lane Hirning, MasterControl product manager, pharmaceutical industry expert.
"Working in conjunction with the Submissions Gateway, the Submissions Locker streamlines the submission document assembly and organisation process starting at the beginning of the submissions cycle by maintaining up-to-date documents in a secure, centralised repository.
"By controlling submissions documentation before, during and after the publishing process, MasterControl makes it possible for all departments involved to have increased confidence in the regulatory submission".
The Submissions Locker is designed to work with the enhanced MasterControl Submissions Gateway to facilitate pre-publishing organisation and control of submissions documents.
The two solutions working in concert give users the peace of mind that they are working with updated, secure and centrally-located documents.
Submissions Locker can work with any publishing tool preferred by the user and allows users to maintain documents in the same format in which submissions are sent to the FDA.
The initial collection and organisation of documents within the Submissions Gateway followed by the export to the Submissions Locker provides secure access for the publishing tool.
This process connects document review and approval processes with the dossier assembly process, accelerating a submission's overall development.
MasterControl users cannot make the mistake of working with unapproved or obsolete documents since the system provides automatic revision control to insure that only the most current version of a document is available.
As soon as an updated version of a document is approved, the Submissions Gateway automatically exports it to the Submissions Locker.
Updates to the Submissions Locker can also be set according to a user-defined schedule.
The MasterControl system insures that all document revisions are linked to the proper submission number and serial number.
Each submission locker is identified with the proper submission number and serial number and linked with correlating parent-child relationships.
When publishing is complete, the submission documents become locked and read-only document in a repository controlled by the Submissions Locker.
The Submissions Locker provides companies doing business in regulated environments with a secure, web-based location where submission document access can be easily controlled.
Once it has been authenticated, MasterControl allows the user's publishing tool of choice to access the Submissions Locker as a standard file share.
Rights to access the folders in the Submissions Locker are exclusively controlled and tracked automatically by MasterControl, making the publishing process more efficient and reducing the imposition on IT departments.
The security of submission documents is maintained by the MasterControl system throughout the publishing process, which speeds up submission times since publishing teams are allowed to focus on publishing instead of chasing down documents.
The Submissions Locker and the enhanced Submissions Gateway function seamlessly with MasterControl's PDF Publishing 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 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.
Because good PDFs are the key to making successful submissions, the three systems - Submissions Locker, Submissions Gateway, and PDF Publishing - work together to provide regulated companies with the tools they need to achieve FDA approval.
