Innovation to Simplify Complex Regulatory Processes
A track record of innovation has vaulted GlobalSubmit’s PUBLISH solution to the top tier of the eCTD publishing market. Foremost among the enhancements we’ve made to the status quo is a big picture process improvement that greatly reduces the number of steps a regulatory professional must perform to arrive at a validated, high-quality output.
Live Validation functionality is the innovation driving single instance output processing. Being able to identify and correct errors in real time, and then publish only the changes, is a tangible advantage as regulatory departments race to meet deadlines and deliver treatments to patients — we call it the ‘Last Mile’.
GlobalSubmit PUBLISH vs. Status Quo
More Efficient PDF Document Publishing and QC
PDF publishing tasks, such as adding external and internal hyperlinks, and performing QC of bookmarks and hyperlinks, account for 80% of the time spent on eCTD compilation. GlobalSubmit’s CROSSCHECK and LINK tools, both found within the PUBLISH system, are designed to facilitate these actions, which are absolutely necessary if sponsors want to create high-quality, compliant submissions in a more efficient manner.
Independent tests show that CROSSCHECK is 8X faster and 3X more accurate when compared to traditional, manual methods of hyperlink and bookmark QC. CROSSCHECK displays a link source and destination side-by-side for quick, easy review. This innovation expedites an activity that accounts for 40% of working time when building an eCTD submission.
LINK streamlines user workflow by cutting out at least 4 publishing tasks per document. Without exiting the PUBLISH interface to access a third party tool, you can set PDF document properties, create bookmarks and hyperlinks and apply headers and pagination. Document updates can then be processed in bulk at industry leading speeds.
Auto Process Regulatory Compliant PDFs
GlobalSubmit PUBLISH eliminates tens of thousands of routine, annual publishing tasks while assuring 100% regulatory compliant PDF documents through auto processing. When the option to automatically process PDF documents according to regulatory compliant settings is turned on, the system only produces compliant PDFs. Time savings are realized as manual, pre-publishing tasks previously performed by the user are now executed by the system.
Regulatory compliant PDF properties include:
- Set Navigation to Bookmarks Panel and Page
- Embed All Fonts
- Inherit Zoom for Bookmarks and Hyperlinks
- Flatten Annotations (excludes hyperlinks)
- Set Fast Web Access
Additional PUBLISH Advantages
- Performance — Intuitive functionality, user-friendly interface plus fast processing. Multi GB submissions “publish out” in a matter of minutes. System only processes deltas or changes.
- Compliant with Internal QC Standards — All edits occur within audit trails; don’t break trail by accessing the copy folder
- Industry Leading Validation Engine — Interpretation of technical errors, presentation of submission content identical to FDA
- Study Tagging Files — Automatically created for you based on information you supply about the study and its documents
- Effectively Manage Hyperlinks — Move PDF documents from one section to another without breaking external hyperlinks
- U.S. FDA – 2.01, 3.3
- EU – 3.0.1 and NeeS
- Health Canada – 2.2
- Australia (TGA) – 3.0
- Swissmedic – 1.3
In a multi-tenant or public cloud environment, many users are accessing a single instance of a software program running on a server. Here, GlobalSubmit PUBLISH is running on shared Amazon Web Services (AWS) infrastructure. Submission data for each company is partitioned into unique, secure buckets within the shared AWS server. These buckets are only accessible with the proper login credentials.
Terms to describe cloud computing for life sciences regulatory publishing are causing some confusion. For the purposes of clarification, GlobalSubmit is technically the SaaS software provider while AWS is the provider of the cloud infrastructure hosting the SaaS application.
Clients who elect to purchase a private Secure CLOUD deployment do not share AWS infrastructure with other users. One of the primary benefits of a private deployment is flexibility with regards to timing of software upgrades.
A local installation of GlobalSubmit PUBLISH allows for complete control over system upgrades, security and validation. Such an installation would require more internal IT resources. Upfront costs and installation time associated with a local installation is greater. Performance, however, is regulated and monitored internally, giving users greater autonomy over the system.