Build it your way
Tables with 28 column types, from people and files to formulas, rollups and signatures. Table, board, calendar, timeline and gallery views. Pages that mix instructions, checklists, live tables and charts.
eQMS · inventory · lot control
The no-code workspace for regulated teams.
Build the records your work needs, from CAPAs and deviations to samples, calibrations and inspections, the way your team already works. Every record gets electronic signatures, locked versions and an audit trail no one can edit, and every release comes with its validation evidence.
Supports 21 CFR Part 11 & EU Annex 11
A live demo on your own process
Your data, your keys
AI assistant that never decides for you
Supplier lot out of tolerance
● Approved · v2
- Item
- Housing, part 40-118 · lot L-2291
- Finding
- Bore 0.04 mm over limit on 6 of 50
- Disposition
- Return to supplier
- CAPA
- CAPA-0058
Approved by Dr. Maya ChenQuality Manager
sha256 7f3a…c91e · content unchanged since signing
✓Validation: PASS
63 requirements traced to tests
63 requirements traced to tests
🔑Encrypted with your key
Built for
Life sciences
Medical devices
Testing labs
Food & beverage
Manufacturing
Aerospace
Why teams switch
Flexible tools don't hold up in an inspection. Regulated systems don't bend.
01
Records live everywhere
Logs in spreadsheets, approvals in email, sign-offs on paper, procedures on a shared drive. Every audit starts with a week of gathering evidence.
02
Workspace apps weren't built for auditors
A “signature” that's really a status change, page history that expires, locks any editor can switch off. Fine for planning; not for controlled records.
03
Regulated systems are rigid and costly
Fixed modules, consultants for every new form, months of revalidation and prices behind a sales call. Teams end up working around them.
The platform
Build it, sign it, prove it, all in one place.
Your team configures tables, forms, pages and workflows themselves. The controls inspectors look for are built in, and the same on every one.
Sign with confidence
Review and approval workflows with electronic signatures: the signer's name, time and meaning, a fresh password or single sign-on check, and a link to the exact content they signed.
Every change, on the record
Who changed what, when, from what to what, for every record, page, permission and setting, kept for as long as the record. The audit trail is append-only in the database itself.
Evidence with every release
Each release ships with a validation report: requirements traced to automated tests, installation checks and deviations, to support your own computerized system validation.
See it in use
Inventory and quality records, in one workspace.
Stock with expiry dates and a Quality release. Deviations that lead to CAPAs. The same signatures, locked versions and audit trail on every one.
Release a lot with a signature.
The person who received a lot can't release it. A second person signs with a fresh password check, the version is locked, and the audit trail records who did what and when.
Text version of this video
- A new lot arrives and is sent for release.
- Quality opens the lot record.
- The second person signs. The author can't sign their own record.
- Signing asks for the password again, and the signature's meaning is chosen.
- The meaning and the password are checked on the server.
- The lot is signed and locked. A change means a new version.
- Every step is in the append-only audit trail: who created, sent and signed it, and when.
Screens show sample data from a fictional company.
AI assistant · add-on
Ask your records anything. It assists; your people decide.
An assistant that knows the platform and the tables you can see. Ask how to do something, ask about your views and automations, get a chart from one sentence, or catch up on a long deviation in a few lines.
- “Where is the filter?” “How do I set a calibration reminder?”, answered with the exact buttons
- “Chart open CAPAs by owner”: a live chart you can add to a page
- Summaries of long records, filters from plain words, suggested columns for new tables
- Sees only what you can see, changes nothing on its own, and every use is logged
Meet the assistant · $15 per user/month
How many deviations do we have by area this quarter?
Most are in Production. Here they are by area:
Add to a page
Written by AI: check it before relying on it.
Compliance you can inspect
We don't just say “Part 11.” We show you how each control works.
Every claim below is enforced by the system and checked by automated tests in the validation report. The same controls answer the record-keeping clauses of ISO 9001, ISO 13485, ISO/IEC 17025 and AS9100.
| Requirement | How Qualsted meets it |
|---|---|
| §11.10(e) Audit trails | Append-only in the database. Times come from the server; database triggers reject any edit or deletion, whoever attempts it. |
| §11.50 · §11.70 Signatures | Name, time and meaning, linked to the content. Each signature stores a SHA-256 hash of what was signed; any later change is flagged. |
| §11.200 Signing | A fresh credential check, every time. A password or a new single sign-on at the moment of signing; failed attempts are recorded. |
| §11.300(d) Misuse | Locked out and reported. Five failed attempts lock the account, and admins are notified at once, in the app and by email. |
| §11.10(c) Protection | Nothing is ever hard-deleted. Records are archived, versions kept, and published versions are locked for good. |
Configure, don't code
Your CAPA log, built in an afternoon.
Start from a table and add the columns you need: IDs, owners, due dates, files, links to other tables. Then save the views each team works from.
- Unique record IDs and required fields, checked on the server
- Form templates, so every record starts the same way
- CSV and Excel import that checks every row before creating any
- Automations and reminders: “when a nonconformance is major, open a CAPA”, “tell the owner 7 days before Due”
| ID | Title | Owner | Due | Stage |
|---|---|---|---|---|
| CAPA-0058 | Incoming inspection sampling | M. Chen | Oct 19 | Action |
| CAPA-0057 | Label printer calibration | J. Patel | Oct 12 | Investigation |
| CAPA-0056 | Cold storage alarm limits | R. Okafor | Oct 08 | Action |
| CAPA-0055 | Courier temperature logs | R. Okafor | Sep 30 | Effectiveness check |
| CAPA-0054 | Training record gaps | A. Silva | Sep 21 | Effectiveness check |
Pages
The procedure and the record, on the same page.
Write instructions, add checklists that record who ticked each step and when, embed live tables and charts, and put the form right where the work happens.
- Checklist stamps set by the server, not the browser
- Record submission: new records added from the page, and listed there
- Page history in the audit trail, and signed PDFs of the page
Receiving inspectionProgress 2 of 3
✓
Check the certificate of conformanceDone by J. Patel · 09:02 EDT
✓
Measure 50 parts against the drawingDone by J. Patel · 09:10 EDT
3
Record any nonconformance belowWaiting
| Nonconformances from this page | Status |
|---|---|
| NC-0142 · Supplier lot out of tolerance | In review |
+ New nonconformance
Review and approval
Signatures in the right order, by the right people.
Set who reviews and approves each table's records. Records lock while in review; approval publishes a version that can never change, and edits go into a new one.
- Signers chosen from the step's group; authors can't sign their own records
- Reviewers are notified in the app and by email
- Rejections return the record with a reason; every version stays readable
1
Reviewed by R. OkaforMeaning: Reviewed · 2026-10-05 11:05 EDT
SIGNED2
Approved by M. Chen (Quality)Meaning: Approved · password re-entered
SIGNED3
Released by Head of QualityWaiting · record locked for editing
Next
Validation package
Evidence for every release, not a binder every three years.
Every release runs the full automated test suite, checks the installation, and traces each requirement to the tests that prove it, in a signed-off PDF report.
- Requirements mapped to Part 11, Annex 11, NIST 800-53 and HIPAA
- Installation and operational qualification (IQ / OQ)
- A renamed or failing test shows as a deviation, never silently passes
Validation report · release 3db40f7PASS
63/63Requirements traced
13/13Installation checks
0Open deviations
| AUD-01 | Audit trail append-only | PASS |
| SIG-03 | Signature linked to content | PASS |
| TEN-01 | Companies isolated | PASS |
| SEC-01 | Each company's own key | PASS |
Day one to day one hundred
Start from a template. Work together. Connect the rest.
17 templatesComments · reminders
API · webhooks · Slack · Teams
Start from a working process
Deviations and CAPA, change control, document control, training, complaints, calibration, suppliers, samples, HACCP and more, with signatures and reminders set up. Install in one click, then change anything.
Work it out on the record
Comments and @mentions on records and pages, kept in the audit trail. Reminders before due dates, calibrations and training expire, and automations on a schedule.
Connect your systems
A documented API with keys that act as a person, signed webhooks when records change, and messages to Slack or Microsoft Teams channels.
QR codes · barcodesScan to open a record
Print QR labels for equipment, samples and lots. Scan with a phone camera or a handheld scanner to open the record, or a supplier's barcode to find the lot.
Industries
The same controls, whatever standard you answer to.
Signed, locked and audited records are required well beyond the FDA. Qualsted speaks your standard's language.
Part 11 · Annex 11 · GMP · GLP
Life sciences
Biotech, pharma, cell and gene therapy, biorepositories and CDMOs.
ISO 13485 · QMSR · Part 11Medical devices
Design history, complaints, device history records and supplier controls.
ISO/IEC 17025Testing and calibration labs
Methods, samples, results, equipment calibration and reports.
FSMA · HACCP · SQF · BRCGSFood and beverage
Monitoring logs, verification sign-offs, corrective actions and audits.
ISO 9001 · IATF 16949Manufacturing
Document control, nonconformance, CAPA, 8D reports and internal audits.
AS9100 · AS9102Aerospace and defense
First-article inspection, traceability, special processes and access control.
Your data, your control
Our staff can't open your workspace unless your admin approves.
Your own encryption key
Each company's files and secrets are encrypted with its own key, or one from your own AWS account. If you revoke your own key, those files and secrets become unreadable to everyone, including us.
Support access you approve
Our engineers can't enter your workspace unless your admin approves, for a set time and level. You can withdraw it at any moment; everything they do is recorded.
Walled off from everyone else
Every company's data is isolated by the database itself, not just the app. Two-step sign-in by default; single sign-on with Entra ID, Okta or Google on every plan.
Pricing
Published prices. Viewers and auditors free.
Pay for the people who create records and sign. Everyone who only reads, exports or audits is free, on every plan.
Standard
$79per user / month, billed annually, from 2 users
Every compliance control, the validation package, single sign-on and your own key.
Enterprise
$129per user / month, from 25 users
Adds required single sign-on, SCIM provisioning, a negotiated quality agreement, supplier audits and validation support.
Add the AI assistant for the people who'll use it: $15 per user/month.
Founding customer program
Five places for teams who want to shape it.
We're working closely with our first customers: we set up your first workflows with you, and your priorities go straight onto our roadmap.
- Your first workflows configured with you, at no extra cost
- Founding pricing, locked for as long as you're a customer
- A direct line to the people who build it
- Validation support for your first go-live
Questions
What regulated teams ask us first.
Does Qualsted make us Part 11 compliant?
No software can on its own. Qualsted provides the technical controls Part 11 and Annex 11 require (audit trails, e-signatures, access control, record protection) and the evidence that they work. Your procedures, training and validation of your intended use complete the picture, and our validation package is designed to support that work. Part 11 in plain English.
We're not in life sciences. Is it for us?
Yes. ISO 9001, ISO 13485, ISO/IEC 17025, AS9100, IATF 16949 and food safety schemes all require controlled documents and records: who approved what, when, and what changed. Those are the same controls, and you build the records your standard asks for.
How long does it take to go live?
Start with one process, such as CAPA, document control or equipment calibration. Because tables, forms and workflows are configured rather than coded, it can be set up in days, then validated for your use. Adding the next process doesn't need a new project.
Where is our data stored?
In Amazon Web Services in the United States, encrypted at rest and in transit, with daily backups and point-in-time restore. Each company's data is isolated in the database, and its files and secrets are encrypted with its own key.
Do you use AI? Is it safe for regulated records?
The AI assistant is an optional add-on, used only by the people you give a seat. It reads what they're allowed to see and suggests; it never signs, approves or changes a record on its own, and every use is logged. Your data isn't used to train models. How it works.
Can we bring data from spreadsheets or our current system?
Yes. CSV and Excel imports check every row against your table's rules before creating anything, and report each problem with its row, so you fix the file instead of cleaning up afterwards.
Can your staff see our data?
Not unless your admin approves a support request, for a time and access level you choose. Approval can be withdrawn at once, and everything a support engineer does appears in your audit trail.
See it with your own process
Bring one workflow. We'll build it with you in the demo.
Tell us what you track today, whether CAPAs, samples or calibrations, and see it running with signatures and an audit trail in 30 minutes.