The FDA's 21 CFR Part 11 allows regulatory information to be signed and submitted electronically and permits the use of electronic record-keeping systems in complying with predicate rules. While automated submission tools can cut costs and save time, they can only be as useful as the submission's content will allow. A submission tool is an advantageous conduit in the submissions process, but just as crucial is a mechanism that can ensure controlled, quality content in the regulatory submission.
To guarantee submission consistency, companies in regulated environments demand that quality initiatives be integrated into the corporate culture organization-wide. The MasterControl Explorer Gateway™ responds to those demands by ensuring control in assembling and tracking documentation vital to submissions. It is an out-of-the-box application that can be integrated with leading e-submission tools, connecting approved documents and forms-based content with the submission assembly process, to accelerate the submission process. The enhanced Explorer Gateway is specifically designed to help companies meet the requirements for good document control within the confines of FDA-regulated GxP environments, including compliance with 21 CFR Part 11.
Any company preparing a submission will use its submission tool of choice, but it still requires an effective means of controlling documents and maintaining shared submission-related files in a secure submission repository. MasterControl provides a centralized repository that controls the creation, sharing, and documentation of submission-related files, regardless of the submission tool in use.
Here's how MasterControl addresses key submission preparation obstacles:
FDA submissions (e.g., for a NDA or IND) can entail thousands of pages that need to be managed, compiled, published, and revised. With a paper-based system, the process can be overwhelming and is prone to error and delay.
MasterControl's centralized repository for all regulatory submission documents makes search and retrieval easy. A single repository also simplifies follow-up submissions and reduces potential agency questions. MasterControl integrates with a company's existing submission tool to streamline and optimize the e-submission process.
Lack of Security
Paper submissions compiled in binders and folders or stored partially in computers provide little security and might not be able to guarantee data integrity. Submissions documents stored on file shares provide only slightly more control. Submission documents in these circumstances may be "uncontrolled" during the entire process.
MasterControl controls submission documents before, during and after publishing. 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.
Lack of Revision Control
In a paper-based or simple file share 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.