85+ modules: CAPA, deviation, change control, OOS, stability, environmental monitoring, dispensing, eBMR, media fill, batch release and more
One GMP platform for pharma of every size.
LIMS, QMS, eBMR and materials on one audit trail — for QC labs and manufacturers. Start with the modules you need, then grow by module and site, from one lab to a multi-site group.
- Live in 1–3 months, cloud-hosted
- One audit trail, no integrations
- Customers in India, UK & beyond
- Pay only for live modules
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- Designed to comply with:
- 21 CFR Part 11
- EU GMP Annex 11
- EU GMP Annex 1
- WHO GMP
- Revised Schedule M
- ALCOA+
- GAMP 5
- 10+
- years of pharma expertise
- 5+
- countries served
- 100K+
- batches released
- 85+
- integrated modules
- CAPA
- Deviation
- Change control
- OOS investigation
- Stability studies
- Environmental monitoring
- Instrument calibration
- Dispensing
- Electronic batch record
- Packaging reconciliation
- Media fill
- Sterilisation
- Batch release
- Recall & traceability
- Supplier qualification
- SOPs
- Training
- Audit trail review
- Quality risk management
- Product quality review
QC labs and manufacturers in the UK and India run on Swat iQua Suite
- ARC Pharma UK LimitedUnited Kingdom · QC laboratory, since 2016
- Lunar Labs LimitedUnited Kingdom · QC laboratory
- Norvium Healthcare Pvt. Ltd.India · API manufacturing
The Swat iQua Suite platform
Four connected products. One audit trail.
Start with the one that hurts most and add the rest when you are ready — every product shares the same records, users and controls.
-
LIMS
Pharma LIMS
Built for QC managers & analysts
- Sample registration to CoA
- Specifications, stability & environmental monitoring
- Instrument calibration with reminders
- Second-person review on every result
-
QMS
Pharma QMS
Built for QA heads & reviewers
- CAPA, deviation, change control, OOS
- Audits and supplier qualification
- SOPs with linked training
- Quality risk management (FMEA)
-
eBMR
eBMR & MES
Built for Production heads & operators
- Master formula & process templates
- Verified dispensing on calibrated scales
- Step-by-step electronic batch records
- Packaging reconciliation & hybrid records
-
ERP
Pharma ERP
Built for Stores, purchase & planning
- Approved-supplier purchasing
- Quarantine-to-release warehouse
- Production planning & MRP
- Distribution, traceability & recall
Watch
Swat iQua Suite in 70 seconds.
Real product footage: e-signed approvals, second-person review, enforced hold points and evidence-based release.
Grows with you
From one QC lab to a multi-site group.
Start with the modules you need today. Add quality, manufacturing and more sites later — on the same records, users and audit trail.
-
Single-site QC lab
Start with the laboratory: samples to Certificate of Analysis, with SOPs and training alongside.
- Testing, review & CoA
- Specifications & stability
- Instrument calibration
- SOPs & SOP-linked training
-
Growing manufacturer
Add quality management, materials and batch records as you grow — nothing re-keyed, nothing to integrate.
- CAPA, deviation, change control & OOS
- Quarantine-to-release materials
- Dispensing & electronic batch records
- E-signed batch release
-
Multi-site group
Run every plant and lab from one installation, with shared or site-owned masters and group-wide oversight.
- Companies & sites in one system
- Shared or site-owned masters
- Group QA sees every site
- Own users, rules & local time per site
One platform vs. four projects
Why buy four systems when one will do?
Buying a LIMS, a QMS, an eBMR/MES and an ERP separately means separate vendors, validations and audit trails. Swat iQua Suite is one platform.
| Separate LIMS, QMS, eBMR & ERP | Swat iQua Suite | |
|---|---|---|
| Vendors & contracts | Three or four vendors, each with its own contract, support desk and roadmap | Yes: One vendor, one contract, one roadmap |
| Validation | Each system validated on its own — plus every interface between them | Yes: One validation effort; each new module inherits the same controls |
| Audit trail | Several audit trails, pieced together for an inspection | Yes: One audit trail across lab, quality, production and release |
| Users & signatures | Separate logins, roles and e-signature set-ups | Yes: One set of users, roles and e-signatures |
| Linked records | Deviation, CAPA, retest and release sit in different systems | Yes: Linked automatically — one click from any record to everything behind it |
| Integrations | Interfaces to build, validate and maintain | Yes: None between modules — one database |
| Rollout | Three or four rollouts and validations, one after another | Yes: Live module by module, typically in 1–3 months |
Keeping other systems? Swat iQua Suite connects to them through a versioned REST API and controlled imports.
See the platformHow Swat iQua Suite connects
Every record flows through one audit trail.
Materials flow in, batches flow out — and every result, deviation and signature lands in the same tamper-evident trail.
Inspection-ready by design
When the inspector asks, answer in minutes — not days.
- “Show me the full history of this batch”
- One record, linked to every deviation, test and signature behind it.
- “Who changed this result, and why?”
- Audit trail with the old value, new value, user, time and reason.
- “Was the operator trained on this SOP version?”
- The batch step would not have opened if they were not.
- “Which CAPAs are overdue?”
- Live register with due dates, owners and effectiveness checks.
- Complete audit trail
- A reason for every change
- Electronic signatures with MFA
- Segregation of duties
- Trusted time
- Audit-trail review
- Role-based access
- Inspection evidence packages
One connected flow
Follow one batch through Swat iQua Suite.
Materials flow in, batches flow out — and every step writes to the same records, under the same compliance controls.
- 01
Supplier qualified
Purchase orders bind only to an approved supplier with a valid quality agreement and GMP certificate.
- 02
Received & quarantined
Goods receipt creates a quarantine lot and decides the testing level. The supplier CoA is stored with a hash.
- 03
Sampled & QC released
QC tests against the approved specification. QA releases the lot only on conforming evidence.
- 04
Dispensed & verified
Only released lots, only on calibrated scales — and a second person verifies every weighing.
- 05
Executed step by step
The electronic batch record enforces hold points, process limits and operator training. Out-of-limit readings raise a deviation.
- 06
Packed & reconciled
Printed components are issued and reconciled before the finished-goods lot is created.
- 07
Tested & CoA issued
Finished-product results are reviewed and approved before the Certificate of Analysis is generated.
- 08
Released with e-signature
The release file assembles itself and shows every blocker. The person who ran the batch cannot release it.
- 09
Shipped & traced
Only released stock ships. Any lot traces back to raw materials and forward to every customer in one view.
Built for your plant
From API to sterile fill — and the labs that test them.
Global compliance
One evidence trail for every market you ship to.
Serving labs and manufacturers in India, the UK, the US, Canada and Africa — FDA, MHRA, EMA, CDSCO and WHO inspections answered from the same records.
Customer stories
Ten years on, they would choose Swat iQua Suite again.
“Ten years on, we would choose it again.”
We moved our QC LIMS onto SwatTech in 2016 and have never looked back. Every specification, result and calibration is one search away, and every change explains itself. When inspectors arrive, we don’t prepare — we simply open the system.
“Audits are something we welcome now.”
In contract testing, our reputation rides on every result we sign. A second-person review on every result, a complete audit trail and a client portal that delivers reports and CoAs on time have turned audits from something we braced for into something we welcome.
“Any batch, traced in one click.”
In API manufacturing, traceability is everything. Today we follow any batch back to its raw-material lots and forward to every shipment in seconds. Revised Schedule M no longer feels like a deadline — it feels like the way we already work.
Your Swat iQua Suite roadmap
Digitalise at your own pace.
Start anywhere. Pay only for what’s live — costs grow with your users and sites as you do.
- Phase 1
Quality foundation
CAPA, deviations, change control, OOS, audits, SOPs, training.
- Phase 2
QC laboratory
Specifications, testing & CoA, stability, environmental monitoring, instruments.
- Phase 3
Manufacturing & release
Materials, dispensing, eBMR, packaging, release, distribution.
- Phase 4
Sterile & insight
Annex 1 controls, product quality review, CPV, risk management, inspection readiness.
FAQ
Questions buyers ask first
Can’t find your answer? Talk to our team — we reply within one business day.
Is Swat iQua Suite only a LIMS?
No. It is one platform for the QC laboratory (LIMS), quality management (QMS), electronic batch records and manufacturing (eBMR/MES), materials, batch release and distribution, and sterile manufacturing — 85+ modules on one audit trail.
Is it right for a small lab or a single site?
Yes. Licensing is modular, so a single QC lab can start with the laboratory modules plus SOPs and training, then add quality, manufacturing and more sites later — on the same records and users.
Can it run a multi-site group?
Yes. One installation runs several companies and sites, with masters shared group-wide or owned by each site, roles and a password policy per site, and entries shown in each site’s local time. Group QA sees quality, production and release across every site.
Does Swat iQua Suite use AI?
Not in GMP decisions. Today 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: every suggestion will be reviewed by a person and recorded in the audit trail.
How long does it take to go live?
Typical go-live is 1–3 months, depending on the modules and sites in scope. Because LIMS, QMS, eBMR and materials are one platform, there are no integration projects between them.
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 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.