Deviations and nonconformances
Record what happened, its severity and where it was found. A rule can open a linked CAPA automatically when a deviation is serious enough, and the board shows what is open, under investigation and closed.
Quality · CAPA · deviations · document control
Quality events and controlled documents, in one system.
Run deviations, nonconformances, CAPA and change control next to the documents and training they affect, so each decision sits beside its evidence. Every approval is a signature, and every change is on the record.
What you run in it
The records a quality team lives in, linked together.
Each one is an ordinary table with a page and a workflow you can change. The starting templates give you a working process on day one.
CAPA and change control
Actions with an owner, a due date and a status, tied to the event that caused them. Changes go through an impact assessment and signed approvals before they take effect.
Documents and training
SOPs with versions, review and approval, locked once published. Training records are related to the documents people must read, so each person's reading list follows the document.
Close the loop
From the event to the fix, without leaving the page.
A deviation links to its CAPA, the CAPA to the change it needs, and the change to the SOP it updates. Reviewers see what is waiting for their signature in one place, oldest first, so nothing sits unnoticed.
- CAPAs linked to the deviations, complaints and audit findings that raised them
- Owners and due dates, with reminders before something is late
- Internal audits, findings and complaints in the same workspace
- My approvals: everything waiting for your signature
Signed and locked
Approval is a signature, and a published version stays put.
The author of a record can't approve it. The approver signs with a fresh password or single sign-on check, the signature records its meaning, and the approved version is locked. A change means a new version, and the old one stays on record with an append-only audit trail beside it.
- Segregation of duties enforced by the system
- Signer, time and meaning on every signature
- Locked versions, with the full history one click away
- Any record's page, history and signatures ready to show an auditor
How it supports your standard
The questions an auditor asks about quality records, and what answers them.
Qualsted gives you the controls and the records; your procedures, training and validation of your own configuration complete the picture.
| Requirement | How Qualsted helps |
|---|---|
| 21 CFR 11.10(e) · Annex 11 §9 | Audit trail. Who created, changed or signed a record and when, recorded by the server and impossible to edit. |
| 21 CFR 11.50 · 11.70 | Signatures linked to records. Each signature shows the signer, the time and its meaning, and stays attached to the exact version it approved. |
| ISO 9001 §7.5 · ISO 13485 §4.2.4 | Control of documents. Versions, review and approval, and a published version that can't be edited in place. |
| ISO 9001 §10.2 · ISO 13485 §8.5.2 | Nonconformity and corrective action. Events, investigations and actions linked together, with owners, due dates and a signed closure. |
Templates
Start from these, installed in one click.
Working processes with signatures, reminders and views set up, as ordinary tables and pages you can change.
Deviations and CAPA
Record deviations, assess their impact, and open a corrective and preventive action when one is needed. CAPAs are reviewed and approved, with reminders before they fall due.
- Deviations 15 columns · IDs like DEV-0001 · signed: QA approval
- CAPA 13 columns · IDs like CAPA-0001 · signed: Reviewed by, Approved by
- Reminder: Deviation due in 3 days
- Reminder: Deviation overdue
- Reminder: CAPA due in 3 days
- Reminder: CAPA overdue
21 CFR 211.192 · FDA QMSR (21 CFR 820) · ISO 13485 §8.5.2 · ISO 9001 §10.2 · EU GMP Ch. 1
Nonconformances
Product or material that doesn't meet requirements: identify it, decide its disposition, and get it approved.
- Nonconformances 14 columns · IDs like NC-0001 · signed: Disposition approved by
- Reminder: Nonconformance due in 3 days
- Reminder: Nonconformance overdue
ISO 9001 §8.7 · ISO 13485 §8.3 · FDA QMSR (21 CFR 820) · AS9100 §8.7 · IATF 16949 §8.7
Change control
Propose, assess and approve changes to processes, equipment, materials or documents before they're made.
- Change requests 13 columns · IDs like CC-0001 · signed: Assessed by, Approved by
- Reminder: Change due in 3 days
- Reminder: Change overdue
FDA QMSR (21 CFR 820) · ISO 13485 §7.3.9 · ISO 9001 §6.3 · EU GMP Annex 15 · ICH Q10
Document control (SOPs)
Controlled documents with versions, review and approval. Each document gets a periodic review date two years ahead, and its owner is reminded a month before it's due.
- Documents 11 columns · IDs like DOC-0001 · signed: Reviewed by, Approved by
- Reminder: Periodic review due in 30 days
21 CFR 211.100 · FDA QMSR (21 CFR 820) · ISO 9001 §7.5 · ISO 13485 §4.2.4 · ISO/IEC 17025 §8.3
Training records
Who was trained on what, when, and by whom, with trainee and trainer sign-off and reminders when training falls due.
- Training records 10 columns · IDs like TRN-0001 · signed: Trainer sign-off
- Reminder: Training due in 7 days
- Reminder: Training overdue
21 CFR 211.25 · FDA QMSR (21 CFR 820) · ISO 9001 §7.2 · ISO 13485 §6.2 · ISO/IEC 17025 §6.2
Complaints
Customer complaints from receipt to closure: investigation, reportability decision, response, and QA approval.
- Complaints 13 columns · IDs like CMP-0001 · signed: Closed by QA
- Reminder: Complaint due in 3 days
- Reminder: Complaint overdue
21 CFR 211.198 · FDA QMSR (21 CFR 820) · ISO 13485 §8.2.2 · ISO 9001 §9.1.2
Questions
What quality teams ask.
Can we bring our existing SOPs and CAPA history?
Yes. Import records from CSV or Excel files and attach the documents themselves; large imports run in the background while people keep working.
Do we have to use your templates?
No. They are ordinary tables, columns, views and pages. Rename a stage, add a field, or build the process from scratch, and keep the signatures and audit trail.
How is this different from a document system on its own?
Documents, deviations, CAPA, change control and training live in the same workspace and link to each other, so a decision sits beside its evidence instead of in a separate tool.
Who can sign a record?
You decide who may approve each kind of record. The system won't let the author of a record approve it, and every signature needs a fresh password or single sign-on check.
Do you provide validation documentation?
Yes. Every release comes with a validation package: requirements, test evidence and an installation check you can run in your own environment. See the compliance page.
See it with your own process