Submissions Gateway allows companies doing business in regulated GxP environments to maintain control in assembling and tracking documentation vital to submissions
MasterControl announces the release of its enhanced Submissions Gateway, 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 organise and 'pre-publish' the approved submissions documents earlier in the process, reducing the time spent searching for and organising 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 organisation of submissions documents in a pre-publishing setting.
The two working together ensure that documents are always up to date and maintained in a single controlled repository.
MasterControl claims Submissions Gateway 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 organisation 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 says this allows the publishing team to focus on publishing - not chasing down documents - resulting in faster submission times.
