Some of the key challenges faced by pharmaceutical companies in preparing the CTD for eSubmissions, and the many ways in which MasterControl eSubmissions software systems can help, are outlined below.
Regulatory Submissions Challenges
MasterControl Explorer Gateway™ Solution
Regulatory submissions (for example, 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 result in delays and errors. MasterControl's eSubmissions systems are specially designed to cater such concerns to make the processes more effective.
MasterControl can be integrated with a company's existing eSubmissions software 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 for ensuring the integrity and authenticity of data. Paper submissions compiled in binders and folders (or stored partially in computers) provide little security which can be secured with an eSubmissions system.
Documents are stored in secure virtual vaults in the eSubmissions software located in a central database for authorized access only. MasterControl automatically locks both login and approval any time a password or login is compromised. The software uses industry-standard SSL and 128-bit encryption capabilities to secure the data communications that take place between the Web browser and the application.
Lack of Revision Control
In a paper-based system, there can 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 ensure that only the most current version of a document (which will go into the eSubmission software) is available. This prevents users from inadvertently working with unapproved or obsolete documents.
Features of MasterControl's eSubmissions Software Systems
Here's a summary of MasterControl features that will assist with electronic submissions:
Interfaces with any system for publishing the eSubmission - Because custom connectors in the eSubmissions software, are not required, the Explorer Gateway work with any publishing system. The initial collection and organization of documents within the Explorer, followed by the export to the submissions publishing tool, connects the document review and approval process with the process of assembling the eSubmission, thereby accelerating the process of submitting the eCTD.
Integrates with Submissions Locker - The enhanced eSubmissions software is designed to work in conjunction with the MasterControl Submissions Locker to allow early stage organization of submissions documents in "pre-publishing" settings. The two solutions working together ensure that documents that eventually will become part of an eSubmission are secure and up to date. MasterControl enables the cross-functional teams to focus on the preparation of the documents that will go into eSubmissions - versus "chasing down documents" - resulting in faster submissions times.
Enterprise-wide Collaboration - MasterControl's eSubmissions software provides a Web-based, enterprise-wide collaboration tool which allows diverse teams of users to work together to revise documents. Redlines of documents are stored for all team members to review, update, and eventually upload as the final copy. Different teams can be included in a sequential collaboration process to promote faster and easier updates to the documents that will eventually go into the eSubmission.
Lifecycle Management - MasterControl provides complete lifecycle management, from the initial creation of a document to its inclusion in the common technical document or eSubmission. The following tools make lifecycle management possible:
- MasterControl's Explorer, similar to the Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Users can compile files in Explorers within the eSubmissions software and later export them to the directory structure of a particular submission. This avoids the extra, time-consuming step of having to integrate the documents. Updating files is easy because system administrators can create virtual folders within Explorers 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 in the eSubmissions software, the InfoCard requires the authorized user who is accessing the file to enter a reason. Through the InfoCard, MasterControl then tracks document changes and provides a secure, time-stamped audit trail as required in 21 CFR Part 11 and other regulations.
The Explorer Gateway copies submission documents and the folder structure to the Submissions Locker and maintains an index of the documents. As documents are approved in MasterControl eSubmissions software, they are automatically copied to the Submissions Locker. If a document is revised at the last minute, the updated approved version is immediately exported to the Locker. Not only does the Explorer Gateway have the capability to export to the Submissions Locker but it can export to a file share as well. In addition, updates to the Submissions Locker can be set according to a user-defined schedule and attachments may be included when documents are exported. Users may choose to export all documents or only those that have been approved.
FDA Submission Templates MasterControl provides appropriate organizer templates (for example NDA, BLA, CTD, IND, etc. templates) to streamline the submission document organization process. These templates create submission appropriate folder structures to allow users to easily link documents to the correct area in the submission folder structure. Users in the eSubmissions software, who have the correct application rights are given the capability to preview, manage, view, create, and delete submissions folder templates, which are in XML format. Templates created by a user-- as well as MasterControl's pre-existing templates -- appear in the Submission Templates drop-down list of the Gateway tab of an Explorer, where they are available for use.
Automated PDF File Generation - To make an eSubmission to the FDA, or other regulatory agencies, files should be submitted in PDF format. MasterControl offers automated PDF conversion of documents in eSubmissions software, which streamlines the processes by not having to manually generate PDF files. Options for creation of bookmarks and hyperlinks are available for Office and PDF documents. The unalterable PDF format also provides added security and control.
Electronic Sign-offs - With MasterControl's eSubmissions software, 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 and other regulations.
Signature Manifest Option - The Include Signature Manifest function allows users to include or exclude the signature manifest on documents that will be exported using the Explorer Gateway, providing a more efficient means of removing unneeded pages from documents when signature manifests are not required.
Export File Names - The Export File Naming Convention gives users the ability to select a naming format via the Explorer Gateway. Users can choose one of several configurations of title, document number, and revision.
Part 11-compliant Features - In addition to e-signature, MasterControl provides other capabilities that fully satisfy FDA's 21 CFR Part 11 requirements with the help of eSubmissions software, such as a time-stamped audit trail that can be linked to the approval process. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.
Web-based Platform - MasterControl's platform is Web-based so that it can connect employees, consultants, and others involved in the submissions process regardless of their physical location.
Other Benefits of MasterControl's eSubmissions Systems
Continuous Validation - MasterControl offers a "continuous validation" approach for effective eSubmissions system that dramatically cuts the time, pain, and cost involved in validation. MasterControl's continuum of innovative products and services, including MasterControl Transfer OQ, ensures that companies go-live faster and more cost effectively.
Product Training - MasterControl's Professional Services team, consisting of former ISO auditors and system administrators, has developed a comprehensive training program to implement eSubmissions Systems that serves as a foundation for successful project implementation and helps companies realize software ROI more rapidly. The team conducts training at MasterControl's state-of-the-art Training Center in Salt Lake City or on-site at the customers' facilities.
Technical Support - Choosing MasterControl's eSubmissions system means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer's needs, from initial installation to regular maintenance.
For More Information about eSubmissions Software Systems
For more information on how MasterControl's eSubmissions software systems can help your pharmaceutical company with its eSubmissions, please feel free to contact a MasterControl representative.