PlatformOne system · one audit trail
The integrated pharma software platform — built on one audit trail.
Swat iQua Suite runs your QC laboratory, quality management, batch records, materials and release on one platform — the same records, the same users and the same compliance controls everywhere.
- 85+ integrated modules
- Role-based dashboards & Action Center
- Multi-company, multi-site
- Cloud-hosted, live in 1–3 months
- 85+
- integrated modules
- 25
- modules enforce segregation of duties
- 3
- e-signature levels
- 7
- regulations designed for
One platform
Eight connected areas. One set of records.
From supplier to released batch — every area shares the same records, users and audit trail, so nothing has to be re-keyed or reconciled.
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Quality Management
CAPA, deviations, change control, OOS, quality events, audits and supplier assessments.
Pharma QMS -
Documents & Training
SOP lifecycle, SOP-linked training with online exams, product knowledge.
Documents & training -
Materials & Purchasing
Requisitions, purchase orders, goods receipt, quarantine-to-release lots.
Pharma ERP -
Manufacturing
Formulas, production orders, dispensing, batch execution, packaging, API.
eBMR & MES -
Batch Records
Electronic batch records, hybrid controlled copies, batch numbering.
eBMR software -
QC Laboratory
Specifications, testing & CoA, stability, environmental monitoring, instruments.
Pharma LIMS -
Release & Distribution
Evidence-based e-signed release, shipments, recalls and traceability.
Batch release -
Sterile & Injectables
Media fills, sterilisation, lyophilisation, CCIT, visual inspection, contamination control.
Sterile manufacturing
Everything visible
Every user starts the day with their open work.
The role-based dashboard and Action Center gather each person’s pending reviews, approvals and due dates from every module — oldest first — so nothing slips between departments.
- Action Center — mine, team, site and approvals scopes across modules and sites.
- Due panels — CAPA, deviation, change control, instruments, stability and training at a glance.
- Widgets per role — QA, QC, production and plant heads each see what matters to them.
- Compliance calendar — every due date from 13 sources on one calendar.
Proven in production
From supplier to released batch — on one platform.
QC labs and manufacturers in the UK, India and beyond run their GMP records on Swat iQua Suite.
See the modules- 10+years building pharma software
- 5+countries with live customers
- 100K+batches managed
- 1–3months typical go-live
One connected flow
Records link themselves — from the shop floor to release.
A deviation raised in a batch step links to the CAPA it creates, the lab retest and the release decision. Controlled masters drive every record, and each one knows which master version applied.
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Deviation raised at the step
Recorded where it happened — batch, product and step already linked.
Batch on hold -
Investigation & CAPA
The root cause and the CAPA it creates stay linked to the deviation.
In progress -
Lab retest reviewed
Results count only after second-person review and an e-signature.
Approved -
Release decision
Blocked until every linked record is closed or assessed.
Released
One click from any record to everything behind it — every step in the same audit trail.
Shared foundation
The compliance controls every module inherits.
Switch on a new module and it arrives with the same audit trail, signatures, access rules and hosting as the rest of the platform.
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Complete audit trail
Old value, new value, user, time and a reason for every change — cross-referenced across related records.
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Electronic signatures
Password, or password plus one-time code, configured per module and per site.
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Segregation of duties
Enforced in 25 modules — the person who ran the batch cannot release it.
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Trusted time
Every entry time-stamped centrally and shown in the local time of the site where the work was done.
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Role-based access
A permission matrix controls every action; every change to it is logged.
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Multi-factor login
Authenticator app or email code, with a password policy set per site.
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Secure cloud hosting
No servers to buy or maintain. Encrypted connections, scheduled backups and your data stored in your chosen region.
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.
Is Swat iQua Suite one product or several?
One platform. LIMS, QMS, eBMR/MES and pharma ERP modules share one database, one audit trail and one set of users, so records link across departments without integration projects.
Do we have to buy every module?
No. Licensing is modular — you pay for the modules active in your current phase, and costs grow with your users and sites. Most customers start with a quality foundation and add the lab, manufacturing and sterile areas over time.
Is it cloud-hosted or on-premise?
Swat iQua Suite is cloud-hosted: no servers to buy, install or maintain on site. Your data is stored in your chosen region, over encrypted connections with scheduled backups.
How long does implementation take?
Typical go-live is 1–3 months, depending on the modules and sites in scope. We map your processes, configure sites, roles and workflows, migrate your history, train your users and support you through go-live.
Which regulations is it designed for?
Swat iQua Suite is designed to comply with 21 CFR Part 11, EU GMP Annex 11 and Annex 1, WHO GMP and Revised Schedule M, following ALCOA+ data-integrity principles and a GAMP 5 risk-based validation approach.
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.