Qualysols is a document management system for regulated teams — version control, e-signature sign-off, and full change history for every SOP, work instruction, and form.
Every SOP, work instruction, and form lives in one version-controlled system — reviewed, approved, and archived on a clear trail.
Version-controlled SOPs, work instructions, and forms with full revision history, redlines, and e-signature sign-off. The current revision is always clearly marked.
Route document changes through review and approval, with old versions automatically archived, never deleted.
Route documents for review and approval with legally binding, timestamped e-signatures at every step.
Automatic reminders when a document is due for periodic review, so nothing goes stale unnoticed.
One-click document packet generation, pulling every version, signature, and approval record.
Run Qualysols as a hosted online service, or deploy it entirely within your own site's infrastructure.
Click through the stages — this is exactly how a document moves inside Qualysols, from first draft to archive.
As of February 2026, the FDA's device regulation runs through ISO 13485. Every document workflow in Qualysols is built around that current framework — not the legacy rules it replaced.
Effective Feb 2, 2026, the FDA's Quality Management System Regulation incorporates ISO 13485:2016 by reference, replacing the old Quality System Regulation. Qualysols is built around this current framework, not the legacy one.
Documents must be reviewed, approved, and kept legible and retrievable, with obsolete versions kept from unintended use. Superseded versions are archived, never deleted.
Electronic signatures must be trustworthy, traceable to the individual, and tamper-evident. Every sign-off in Qualysols is timestamped and permanently linked to that document's history.
Reach out and we'll walk through your document process — pricing and plans discussed on the call.
Tell us a bit about your team — we'll walk through your document process and cover pricing and plans on the call.
Our team has your email and will reach out shortly to schedule a walkthrough.
Something went wrong sending that — please try again, or email us directly at management@qualysols.com.