FAQ

Frequently Asked Questions

What distinguishes GlobalSubmit’s eCTD publishing software from competitor solutions?

PUBLISH is a mature, innovative eCTD publishing system that differs significantly from the status quo.

The greatest achievement of our publishing system is that it reduces what was previously a 6-7 step process to 2 steps. A number of individual innovations make this possible.

LINK in PUBLISH and CROSSCHECK boost productivity by introducing greater efficiency in PDF document publishing and submission quality review, respectively.

Live Validation gives a user the ability to identify and correct technical errors in real time without having to first publish out. The system runs validation checks for the region specified as documents are loaded. At the same time, PUBLISH processes PDFs and checksums in the background. Publishing out takes minutes compared to hours or days; the only processing that remains is the XML backbone.

When last-minute changes are needed, our system processes only the delta; the changes since the last publishing action. Last-minute edits can be performed in the PUBLISH system itself, which doesn’t raise the specter of breaking the audit trail.

The risk of submission delay is greatly lessened by Live Validation and our Delta Publishing functionality.

Describe how your software products support the new US FDA Module 1 requirements (e.g., Promotional Material submissions, Grouped submissions, eCTD metadata).

Having collaborated with the FDA on the technology to support the new specifications, GlobalSubmit PUBLISH was compliant with the new US Module 1 v2.3 well ahead of the Agency’s public go live date of June 15, 2015.

To support Promotional Labeling and Advertising submissions, section 1.15 was added as a possible Repeatable Section in PUBLISH for the input of promotional material audience type – professional or consumer. Additional metadata attributes for Promotional Material Document Type, Promotional Material Type and Material ID were also built into the system.

The DTD v3.3 application wizard supports creation of Grouped Submissions. The Regulatory Activity In field is used to group together applications. On the REVIEW side, GlobalSubmit’s tool is able to point all submissions in a group to the database where the physical files reside.

In terms of metadata, date of submission, sequence number and related sequence number were removed were removed according to FDA specifications.New metadata attributes such as DUNS number are either captured in the PUBLISH Application Wizard or automatically processed as part of the XML.

What regulatory services does GlobalSubmit provide?

Yes. GlobalSubmit offers a number of regulatory services, including regulatory publishing, migration services, regulatory operations consulting, regulatory affairs, structured product labeling (SPL), tobacco submissions, medical writing, and training and implementation.

How is GlobalSubmit software priced?

GlobalSubmit offers two models of software license pricing – subscription and perpetual. Subscription licenses are available in single or multi-year installments; costs are determined on a per seat basis. We also offer perpetual licenses for those who wish to purchase applications outright.

Other than the FDA, what Regulatory Agencies does GlobalSubmit work with?

GlobalSubmit’s full software suite is fully compliant and up-to-date with submission criteria for EMA, Health Canada and Swissmedic.

What is the latest version of GlobalSubmit software available? What version is the FDA currently using?

The most recent release of our software is GlobalSubmit 2015 R2 (Version 9.0.3). The FDA is currently using 8.2.2.

Is GlobalSubmit compatible with leading publishing and document management systems?

If you have filed electronic regulatory submissions with the U.S. Food & Drug Administration, those applications were processed using GlobalSubmit’s software platforms. Therefore, our full software suite offers interoperability with any system you’re using, and we can offer seamless conversion to our platforms.

GlobalSubmit applications use the XML output from your publishing system as input for our VALIDATE™ software. We also offer our own PUBLISH™ platform. Our software suite works in conjunction with SharePoint and Documentum-based systems such as FirstDoc.

Are you 21 CFR Part 11 compliant?

GlobalSubmit’s PUBLISH™ product provides compliance with the FDA’s ruling on Electronic Records and Electronic Signatures (21 CFR Part 11). The final determination of compliance for any application, including PUBLISH, rests with our clients and is subject to their interpretation of Part 11. Other components of GlobalSubmit’s full suite are not subject to 21 CFR Part 11 as they do not create, modify, or delete any record required under a predicate rule. We follow best practices in software development, documentation, staff training, etc., so we are compliant as the regulations relate to our solutions.

Where can I connect with GlobalSubmit’s management team in person?

GlobalSubmit executives participate in a number of educational seminars and industry events throughout the year. We also offer web-based discussions on a recurring basis. For a full list of scheduled events, please visit our event calendar. To inquire about the availability of a member of our management team for your event, please email marketing@globalsubmit.com.