From first draft to archive
Every document moves through the same states: draft, review, approval, release and archive. Superseded versions are archived, so your team always works from the version in force.
Controlled documents
built for quality
Manage every controlled document and record in one system, from first draft to archive, with full version history and compliant e-signatures.
- Draft to archive version control
- Compliant e-signatures (21 CFR Part 11)
- An audit trail that can’t be edited or deleted
Trusted byquality teams
Features
Every version, approval and signature
on the record
Custom approval flows for every document type
Set who reviews and approves each document type, in the order you need. Drafts sit alongside the version in force until they're approved, with every reviewer and approver named.
Live placeholders that keep every document current
Approval tables, document status, version numbers, owners and review dates update themselves inside the document, so nobody edits a cover page or revision table by hand.
Electronic signatures that meet 21 CFR Part 11
Every signature records who signed, what they were signing for and when, so it carries the same weight as a handwritten one.
A complete audit trail for every document
See who changed what and when, and compare versions side by side. Entries can't be edited or deleted, even by your own administrators.
Write and update SOPs with AI
Start from our SOP and policy library, then draft and update in the AI-native editor. Every AI suggestion is a tracked change that a named person accepts.
Free migration of your existing documents
Our team moves your existing QMS documents into controlled Assuric documents for you, with version history intact.
Benefits
Stay in control of every sign-off
Spend less time on manual work
Approval flows, e-signatures and AI drafting take care of the repetitive work, so keeping documents current takes minutes, not a quarterly clean-up.
Know exactly what's approved
Everyone can see which documents are in force, who approved them, and which drafts are still under review.
No more chasing signatures
Reviews and approvals go straight to the right people in the right order, so documents don't sit in an inbox waiting to be signed.
Be audit-ready all year round
Every version, approval and signature is already on the record, so audits are a review of what's in Assuric, not a hunt through shared drives.
Ready for international markets
Document control that meets FDA 21 CFR Part 11 in the US and EU MDR, UK MDR and ISO 13485 in Europe and the UK, so your QMS is ready wherever you sell.
Trusted by healthtech’s very best
“We couldn't speak highly enough of both the Assuric team and the platform itself, which is incredibly easy to use, and with the skill and hardworking nature of the Assuric team. They've been a key component in accelerating our progress and deployments!”
Maks Kozarzewski
COO, VitVio
“The Assuric platform is a game changer in the clinical risk management field. It has been carefully designed to make the job of a CSO significantly more streamlined. The team are excellent and responsive to any product suggestions I have requested, and it has been a pleasure to work with them.”
Paul Llewellyn
CCIO, Accenture
“Assuric has been fantastic in helping us quickly and safely navigate regulatory compliance in the UK. From completing Cybersecurity requirements to DSPT, DCB0129, and DTAC, the team was supportive, extremely knowledgeable, and the platform made everything quick and straightforward. A separate regulatory company we consulted at the beginning even remarked on how quickly we achieved compliance!”
Katie Baker
Director UK & Ireland, Tandem
Mapped to other frameworks
Overlapping requirements and evidence are mapped across frameworks automatically, so you never do the same work twice.
Frequently asked questions
It is the FDA regulation covering electronic records and electronic signatures. It sets out what a system must do for an electronic signature to count as equivalent to a handwritten one: recording the signer’s identity, the meaning of the signature and the time of signing, and keeping a secure audit trail.
You need them to place a medical device on the US market, and partners, notified bodies and larger customers often expect them even where they aren’t strictly required. Assuric provides them as standard.
Yes. The same document control satisfies ISO 13485 document and record requirements, which underpin EU MDR and UK MDR, alongside FDA 21 CFR Part 11. Evidence is mapped once and reused across your other frameworks.
A controlled document has a named owner and approver, a version history, a review date and a defined status, so you can prove which version was in force at any point in time. A file in a shared drive can’t do that.
Yes. Training, hazards, quality events and evidence keep the same version history, sign-off and audit trail as your SOPs, so every record is as controlled and traceable as your policies.
Yes. Choose who reviews and approves each document type, and in what order. Drafts stay alongside the version in force until every approver has signed.
No. Entries are written as the work happens and can’t be edited or deleted afterwards, even by your own administrators. Every version, approval and signature stays on the record for the life of the document.
Yes. Our team migrates your existing QMS documents into controlled Assuric documents for free, with version history intact.
Document control
that actually works
Talk to us about moving your QMS documents into a
pain-free system, with free migration included.