Question 1

What is regulatory archiving software?

Accepted Answer

Regulatory archiving software preserves a company's filed submissions, sequences, and regulatory documents in a compliant, searchable long-term archive. Regulatory records must be retained for years, often well beyond a product's active life, and must be retrievable in their original form for inspections, audits, litigation, and follow-up filings. Archiving software provides that durable, defensible store with the metadata, retention controls, and search needed to find and produce any record on demand, rather than relying on scattered drives and legacy systems.

Question 2

How is archiving different from document management?

Accepted Answer

Document management handles documents while they are active: drafting, review, approval, and version control. Archiving handles records after they are final and filed: long-term preservation, retention enforcement, and retrieval over a multi-year horizon. A document in a DMS is a living artifact; an archived record is a fixed, defensible snapshot of what was filed. Assyro connects the two so a filed sequence flows from the active workspace into the archive with its history and context preserved.

Question 3

What record retention requirements does archiving support?

Accepted Answer

Regulatory record retention requirements vary by authority, record type, and region, and many GxP records must be retained for years after a product is withdrawn. Assyro lets you apply retention policies to archived records so each is preserved for the required period and handled correctly afterward, with an audit trail of retention actions. Because requirements differ across markets, the system supports per-region and per-record-type retention rather than a single blanket rule.

Question 4

Is the archive built to support 21 CFR Part 11?

Accepted Answer

Yes. The archive preserves records with the audit trails, access controls, and integrity protections that 21 CFR Part 11 and EU Annex 11 expect for electronic records, so an archived submission remains attributable, complete, and unaltered over its retention period. As with any Part 11 system, full compliance also depends on the customer's validation and SOPs; Assyro provides the system controls and documentation that support them.

Question 5

Can we retrieve old submissions for an inspection or follow-up filing?

Accepted Answer

Yes, that is the core use case. The archive is searchable by product, submission, sequence, region, and date, so retrieving a specific historical document or an entire prior sequence is fast. For inspections, you can produce the exact record requested with its metadata and history. For follow-up filings, you can pull a prior sequence as the baseline for the next one, instead of reconstructing what was filed from scattered copies.

Question 6

How does archiving fit with publishing and submission management?

Accepted Answer

Submission management plans and tracks the filing, publishing assembles the final sequence, and archiving preserves it once filed. In Assyro the three connect: when a sequence is published and filed, it flows into the archive as a fixed record with its full history. This means the long-term archive is populated automatically as part of the submission workflow, rather than being a separate manual step that gets skipped under deadline pressure.

eCTD Archiving Software: Find Any Sequence You Ever Filed in Seconds

How Archiving Fits the Submission Workflow

Every Filing Preserved, Not Scattered

Retrieve History in Seconds, Not Days

Retention Rules Enforced by Region

An Archive the Whole Team Can Use

Controls and Traceability for Archiving

Keep Archiving Audit-Ready

Scale Across Programs Without Adding Complexity

Questions About Archiving

See Archiving in a Live Submission Workflow.