Question 1

What is a life sciences document management system?

Accepted Answer

A life sciences document management system, often called an EDMS, stores and controls the regulated documents a pharma, biotech, or MedTech company produces. That includes protocols, reports, specifications, Module 2 and Module 3 content, and correspondence. Unlike a file share, it enforces version control, records an audit trail of every change and approval, applies electronic signatures, and restricts who can edit or approve. The aim is one defensible copy of each document that holds up in an inspection.

Question 2

What is Assyro DMS?

Accepted Answer

Assyro DMS is a regulatory document management system (DMS) for pharma, biotech and MedTech teams, part of the Assyro AI compliance platform. It keeps controlled documents version-managed, reviewed, approved, and signed, and links each one to the eCTD section it supports.

Question 3

How is an EDMS for life sciences different from SharePoint or Google Drive?

Accepted Answer

A generic file share stores files but does not enforce regulatory controls. It does not give you controlled check-out, regulated electronic signatures, an audit trail built for inspection, or a link between a document and the submission section it supports. Teams that run regulated work on a generic drive tend to end up with conflicting copies and no reliable record of who approved what.

Question 4

What does GxP document management require?

Accepted Answer

GxP document management expects records to follow ALCOA+ principles: attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available. In practice that means version control, an audit trail of changes, controlled review and approval, restricted access, and records that can be retrieved for the whole retention period. Assyro DMS provides those system controls. Your SOPs define how your team uses them.

Question 5

How does Assyro DMS connect documents to eCTD submissions?

Accepted Answer

Each controlled document maps to the eCTD module, section, and lifecycle state it supports. When a document's approved version changes, the submission view points to the current approved version. Authoring, validation, and publishing work from the same source instead of copying files between systems.

Question 6

Does Assyro DMS support 21 CFR Part 11 and EU Annex 11?

Accepted Answer

Assyro DMS is Part 11-capable. It provides audit trails, access controls, electronic signatures tied to the signer and the reason for signing, and version history that cannot be silently altered. The same controls map to EU Annex 11 expectations for computerised systems. Compliance also depends on your validation, SOPs, and training, which no software provides on its own.

Question 7

Can reviewers compare document versions before approval?

Accepted Answer

Yes. Version comparison shows what changed between two versions of a controlled document. Reviewers use it to confirm that only the intended edits were made before they approve, and quality teams use it to explain the reason for a change during an audit.

Question 8

Which teams use a life sciences EDMS?

Accepted Answer

Regulatory affairs, regulatory operations, quality assurance, CMC, clinical, and medical writing teams all author or approve controlled documents. An EDMS gives them one place to draft, review, approve, and retrieve those documents, with the same controls applied to everyone.

Keep GxP Documents Connected to Your Submissions

An EDMS Built Around Regulated Documents

One Controlled Version of Every Document

GxP Documents Linked to the Submission

Review and Approval With E-Signatures

An Audit Trail You Can Hand to an Inspector

Controls Your Quality Team Can Stand Behind

Built to Support Part 11 and Annex 11

Documents and Submissions in One Workspace

Guides for your next decision

Questions About Life Sciences Document Management

See Assyro DMS on Your Own Documents.