Submissions Software
Features & Benefits

for the Biotechnology Industry

eSubmissions Software to Automate FDA Electronic Submissions in a 21 CFR Part 11 Compliant Manner

Under 21 CFR Part 11, the FDA allows companies to submit regulatory information electronically and to use electronic record-keeping systems in complying with predicate rules. The regulation also makes electronic signatures as valid as handwritten signatures.

How can MasterControl Submission Gateway™ Benefit You?

MasterControl Submissions Gateway? facilitates electronic delivery of FDA submissions by providing control in assembling and tracking necessary documentation. Here's a glance at some key challenges faced by companies in preparing their FDA submissions:

FDA Submissions Challenges		MasterControl Submissions Gateway™ Solution
Inefficient Processes FDA submissions (i.e. for a new drug or investigational drug application) can entail thousands of pages that need to be managed, compiled, published, and revised when necessary. With a paper-based system, the process can be overwhelming and is likely to cause delays and errors.		Efficient Process MasterControl can be integrated with a company's existing submission tool to streamline and effectively manage the process of electronic submission. MasterControl provides a centralized repository for all regulatory submissions, making search and retrieval easy. MasterControl is Web-based so it's accessible to all authorized users regardless of location.
Lack of Security 21 CFR Part 11 has specific security requirements to ensure the integrity and authenticity of data. Paper submissions compiled in binders and folders or stored partially in computers provide little security.		Secure Repository Documents are stored in secure virtual vaults located in a central database for authorized access only. Automatically locks both login and approval any time a password or login is compromised. 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 system, there could be multiple (unwanted) versions of documents. Modifying a document entails time-consuming meetings and manual change.		Automatic Revision Control MasterControl's ?check out? and ?check in? feature provides automatic revision control to ensure that only the current version of a document is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports.

Features

Here's a summary of MasterControl Submissions Gateway's features:

Integrates with Other Submission Tools - MasterControl 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 dossier assembly process, to accelerate the submission process.

Lifecycle Management ? MasterControl provides complete lifecycle management, from document creation to submission, with the help of the following tools:

• MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Users can compile files in Organizers and later export them to the directory structure of a 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 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. Through the InfoCard, MasterControl then tracks document changes and provides a secure, time-stamped audit trail as required by 21 CFR Part 11.

FDA Submission Templates - MasterControl provides appropriate templates (i.e., NDA, BLA, CTD, IND) to streamline the dossier-creation process.

Automated PDF file generation ? To make an electronic submission to the FDA, the agency requires that electronic files of regulatory information be submitted in PDF format. MasterControl offers automated PDF conversion of documents, streamlining the process by not having to manually generate PDF files. The unalterable PDF format also provides added security and control.

Electronic sign-offs ? With MasterControl, documents can be signed and approved electronically. Signature manifestation ? name, date, time, and meaning of electronic signature ? can be appended automatically to each document as required by 21 CFR Part 11.