Question 1

What is a regulatory document management system (DMS)?

Accepted Answer

A regulatory document management system is software that stores, version-controls, and tracks the controlled documents a regulatory team produces for submissions, such as Module 2 summaries, Module 3 quality sections, protocols, reports, and correspondence. Unlike a generic file share, a regulatory DMS enforces version control, captures an audit trail of every change and approval, applies electronic signatures, and links each document to the submission section it supports. The goal is a single defensible source of truth that holds up under an inspection or audit.

Question 2

How is a regulatory DMS different from SharePoint or Google Drive?

Accepted Answer

Generic file shares store files; they do not enforce regulatory controls. SharePoint and Google Drive do not give you a validated audit trail, controlled check-out, regulated electronic signatures, or links between a document and the eCTD section it supports. Teams that run submissions on a generic drive usually end up with multiple conflicting copies, broken links, and no reliable history of who approved what. A regulatory DMS adds the version control, access control, audit trail, and submission linkage that a generic share cannot provide.

Question 3

Does Assyro's document management support 21 CFR Part 11?

Accepted Answer

Yes. Assyro's document workflow is built to support 21 CFR Part 11 requirements for electronic records and electronic signatures: complete audit trails, access controls, signature manifestations tied to the signer and reason, and version history that cannot be silently altered. For teams filing in the EU, the same controls map to EU Annex 11 expectations for computerised systems. Part 11 readiness also depends on your own validation and SOPs, so Assyro provides the system controls and documentation your quality team needs to complete validation.

Question 4

How does document management connect to eCTD submissions?

Accepted Answer

Each controlled document maps to the eCTD module, section, and submission lifecycle state it supports. When a Module 3.2.S.4 specifications document is updated, the link points to the current approved version, and the submission view reflects it. This keeps authoring, validation, and publishing working from the same source instead of copying files between systems and losing track of which version made it into the sequence.

Question 5

Does this replace Veeva Vault or MasterControl?

Accepted Answer

For submission-centric regulatory teams, Assyro can be the system of record for the documents that go into a submission, with the version control, audit trail, and eCTD linkage those documents need. Larger organizations that already run an enterprise Vault or MasterControl instance can integrate instead: Assyro links its submission workflow to documents that live in those systems. The right answer depends on whether you want a single submission-focused workspace or an integration with an enterprise content platform you already operate.

Question 6

How does a regulatory DMS support audit and inspection readiness?

Accepted Answer

Inspection readiness comes down to being able to show, quickly and defensibly, the history of a document: who authored it, who reviewed and approved it, what changed between versions, and why. A regulatory DMS captures all of that automatically as work happens, following ALCOA+ data integrity principles (attributable, legible, contemporaneous, original, accurate, and complete). When an inspector or auditor asks for a document's history, it is a search that returns the full trail rather than a scramble through email and shared drives.

Question 7

Can multiple authors and reviewers work on documents together?

Accepted Answer

Yes. Controlled check-out and version history prevent the overwrite problem where two people edit the same file and one set of changes disappears. Authors draft, reviewers comment and approve, and every action is tracked against the document version. The team collaborates in one place without losing the controlled, auditable record that regulatory work requires.

Question 8

Can it compare document versions to show what changed?

Accepted Answer

Yes. Version comparison shows exactly what changed between two versions of a controlled document, which is essential when a reviewer needs to confirm that only the intended edits were made before approval, or when reconstructing the rationale for a change during an audit. This is the regulatory-affairs equivalent of redline comparison, tied to the controlled version history rather than to ad hoc copies of the file.

Regulatory Document Management Software That Stays Audit-Ready

How Document Management Fits the Submission Workflow

One Controlled Version, Not Five Conflicting Copies

Documents Stay Linked to the Submission They Belong To

A Defensible Audit Trail for Every Change

Find the Right Document Without Hunting Through Folders

Controls and Traceability for Document Management

Keep Document Management Audit-Ready

Scale Across Programs Without Adding Complexity

Questions About Document Management

See Document Management in a Live Submission Workflow.