SecurityInspection-ready by design
GxP cloud software security your inspector can verify.
Every action in Swat iQua Suite is authenticated, authorised, signed where it matters and recorded in a tamper-evident audit trail — the controls behind 21 CFR Part 11 and EU GMP Annex 11.
- MFA with authenticator app or email code
- 3 e-signature levels, per module
- Segregation of duties in 25 modules
- Periodic audit trail review
- 3
- e-signature levels
- 25
- modules enforce segregation of duties
- 2
- MFA methods
- 7
- regulations designed for
Identity & access
The right person, with the right rights.
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Multi-factor login
Authenticator app or email code, with a password policy set per site.
- Forced password change at first login and on expiry
- Time-limited lockout after repeated failed logins or MFA codes
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Role-based access
Global roles assigned per site; a permission matrix controls every action.
- Editing the matrix needs its own permission
- Every permission change logged — added and removed
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GMP actors only
Only internal, active users can perform GMP actions; client-portal users see only their own company’s records.
- Block, unblock and deactivate with a recorded reason
Electronic signatures
Signatures that mean something — and prove it.
E-signatures are configured per module and per site: password, or password plus a one-time code. Segregation of duties is enforced where it matters, and any administrator override is recorded and shown on the record and its print.
- 3 signature levels — chosen per module and per site.
- Segregation of duties — reviewer ≠ preparer, approver ≠ reviewer, operator ≠ releaser.
- Overrides are visible — recorded and printed on the record itself.
- Meaning of signature — each signature is bound to the action, user and time.
Segregation of duties
Four people. Four signatures. One record.
Where it matters, each step is signed by a different person — the system enforces it, and any permitted override is recorded and printed on the record.
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Prepared
The record is completed and signed by the person who did the work.
Signed -
Reviewed
A second person checks it — the preparer cannot review their own work.
Signed -
Approved
Approval needs a different user again, with password plus code where configured.
Signed -
Released
The person who ran the batch can never release it.
Released
Each signature is bound to the action, the user and a trusted time-stamp.
Audit trail, data integrity & hosting
A complete, reviewable record — on infrastructure you never maintain.
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Complete audit trail
Old value, new value, user, time and reason for every change — filterable by site, module, user and date, and cross-referenced across related records.
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Periodic audit trail review
Risk-based runs flag deletions, privileged and configuration changes, after-hours activity and changes after approval — findings can raise a CAPA.
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Inspection evidence
Audit trails export to PDF and Excel, every export logged; inspection packages carry a checksummed, tamper-evident file manifest.
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Secure cloud hosting
No servers to buy or maintain. Encrypted connections, scheduled backups, automatic log archiving, data in your chosen region.
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Trusted time
Central time-stamps, shown in each site’s local time.
AI with GMP discipline
No black box in your GMP records.
Inspectors need to know who did what, and why. So in Swat iQua Suite every GMP record has a named author and every decision a named signatory — and that will not change as AI arrives.
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Today: people decide
Every GMP record is created by a named person and every decision is e-signed. Nothing is generated or altered by a model.
- Deterministic, explainable workflows
- Rules you can read and validate
- Every value traceable to a person
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On our roadmap: AI that suggests
AI assistance is on our roadmap — designed to suggest and never decide, so your team stays in control of every GMP outcome.
- Suggestions, never decisions
- Reviewed and accepted by a person
- Switched on only when you choose
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Always: on the audit trail
Any future AI suggestion will be recorded in the same audit trail as everything else — what was suggested, who accepted it and when.
- Same audit trail, same e-signatures
- Aligned with EU GMP draft Annex 22 thinking
- Validated like any other function
FAQ
Frequently asked questions
Can’t find your answer? Talk to our team — we reply within one business day.
Does Swat iQua Suite use AI to make GMP decisions?
No. Every GMP record is created by a named person and every decision is e-signed — nothing is generated or changed by a model. AI assistance is on our roadmap, designed to suggest and never decide: any suggestion will be reviewed by a person and recorded in the audit trail.
Does Swat iQua Suite support multi-factor authentication?
Yes. Users can sign in with an authenticator app or an email code, with a password policy set per site. Repeated failed logins or MFA codes trigger a time-limited lockout.
How do electronic signatures work?
Signatures are configured per module and per site: password only, or password plus a one-time code. Each signature is tied to the action, the user and the time, and segregation of duties prevents the same person preparing and approving.
Can an administrator bypass segregation of duties?
Where an override is permitted, it is recorded and shown on the record and on its print, so an inspector sees it immediately.
How is the audit trail reviewed?
Periodic, risk-based audit trail review runs highlight deletions, privileged and configuration changes, after-hours activity and changes after approval. Reviewers record findings, which can raise a CAPA, and QA approves the review with an e-signature.
Where is our data hosted?
In your chosen region, on secure cloud hosting with encrypted connections, scheduled backups and automatic log archiving. You can export your data to Excel and PDF at any time.
Who is responsible for validation?
Validation of each installation remains the regulated company’s responsibility. We support a risk-based approach consistent with GAMP 5, including CSA requirement traceability and implementation documentation.
Ready to see Swat iQua Suite in action?
Book a free, personalised demo and see how Swat iQua Suite takes your plants, labs and quality teams from paper to inspection-ready.