Beta

The beta is the first release of eCTD Hub as a service. It covers the full path from an empty workspace to a published GCC sequence.

Workspace and accounts

Self sign-up with a business email. The first user becomes the Tenant admin and the company domain belongs to the workspace.
Sign-in with a password, or single sign-on through OpenID Connect or SAML 2.0, with optional enforcement and a break-glass administrator.
Password reset, account lockout after failed attempts, and administrator unlock.
English and Arabic (right to left), light and dark mode.

Invitations with five roles: Tenant admin, Publisher, QA reviewer, RA specialist and Viewer.
Deactivate and reactivate users. The workspace always keeps one active administrator.
General settings: company name, default language, session length, account creation on first single sign-on.
Branding: workspace colours with a readability check, a logo in the menu, and the default light or dark mode.
Email delivery through eCTD Hub, your own SMTP server, or Microsoft 365 through Microsoft Graph, with a built-in setup guide and a test email.
Append-only audit trail with filters.

GCC region pack: Module 1 v1.5, DTD 1.1, validation criteria v1.4, for the United Arab Emirates, Bahrain, Kuwait, Oman, Qatar, Saudi Arabia (default) and Yemen.
Products and sequences: the initial sequence 0000 and next sequences built from the published history.
Compiler with the CTD tree, drag-and-drop upload (PDF, DOCX, XML, TXT, JPG, PNG or XPT, up to 1 GB), file names, eTOC titles and languages.
Lifecycle operations: new, replace, append and delete.
Envelope entered once for all countries, with per-country agency, applicant and invented name.
Validation with errors, warnings and Fix links.
Review with electronic signature and segregation of duties.
Publishing with PDF optimisation, index.xml, MD5 checksums and a downloadable ZIP package.
Lifecycle view: current, cumulative and by sequence.
A “Waiting for you” task list on the Products page.

Quick search from any page with Ctrl+K or Cmd+K, and a full search page with result types, filters and paging.
Searches products, sequences, CTD folders (by code, number, title or package path), documents and the text inside PDF, TXT and XML files. Tenant admins can also find users.
English and Arabic word forms, "exact phrase", -exclude and OR, and close matches for small typos.
Badges show when a document’s text is still being read or has no text layer.

Every error message says exactly what went wrong, in English and Arabic.
Unexpected errors show a Reference. Send it to support at info@masarcorp.com so we can find the request.

Signing an approval needs an eCTD Hub password. Signing with single sign-on re-authentication is not available yet.
Allowed email domains: only the sign-up domain. Adding domains verified by DNS comes later.
Only the GCC region pack is available.
Search reads the text of PDF, TXT and XML files. Word (DOCX) text is not searched yet.
The package check reports “Valid with warnings” when the official GCC DTD and stylesheet files are not installed in the region pack.

More regions, NeeS, a PDF toolbox and a sequence comparer. Dates are not fixed.