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.
Select all the resources you’re interested in downloading
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.