Modules85+ integrated modules
Every module you need — on one audit trail.
Quality, laboratory, manufacturing, sterile and supply modules that share the same records, users and compliance controls. Start with the ones that matter most and add the rest when you are ready.
- Licensed module by module
- Same audit trail and e-signatures everywhere
- Shared masters across sites
- 85+
- integrated modules
- 5
- areas
- 25
- modules enforce segregation of duties
- 3
- e-signature levels
Browse by area
Find your module.
Quality management (eQMS) 11
Every quality record linked to the next — from the event that raised it to the verified closure.
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CAPA Management
One CAPA register fed by deviations, OOS, quality events, audits and audit-trail review — tracked to effectiveness and verified closure.
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Deviation Management
Deviations raised from batch execution and other shop-floor events, reviewed, approved and closed with verified actions.
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Change Control
GMP change control with review, approval and an effectiveness review after closure.
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OOS & Lab Incident Investigation
Staged, level-by-level OOS investigations and lab quality events, reviewed and approved at every level.
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Audit Management
Internal, external and supplier audits with observations raised straight into CAPA.
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Quality Risk Management (FMEA)
Controlled FMEA risk registers with automatic severity × occurrence × detection scoring, e-signed.
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Supplier & Vendor Qualification
Scheduled assessments, site risk ratings, versioned quality agreements and expiry digests, per site.
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SOP & Document Control
SOPs from draft through review and approval to effective, with controlled print.
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Training Management
SOP-linked read-and-accept training with server-graded exams and certificates; new SOP versions supersede old training.
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Audit Trail & Data Integrity
A cross-module audit trail report, periodic risk-based review and second-person raw-data review.
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Inspection Readiness
Inspection evidence packages assembled from your records, with a tamper-evident file manifest.
QC laboratory (LIMS) 7
From sample registration to approved result and CoA — every value reviewed before it counts.
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Sample & Testing Management
Samples registered, routed, tested, reviewed and approved — with reagent and standard inventory.
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Specification Management
Versioned product and material specifications with acceptance criteria and test method trees.
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Stability Study Management
ICH stability studies with a server-computed pull schedule; each pull creates its lab tests.
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Environmental Monitoring
Cleanrooms, monitoring points, alert and action limits, EM sessions and gowning qualifications.
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Instrument Calibration & Maintenance
An append-only instrument register with calibration and maintenance records and due reminders.
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Contract Lab Client Portal
Clients submit sample requests and receive released results, reports and CoAs through a portal.
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In-House QC Testing (RM / IP / FP)
Specification-driven testing of raw materials, in-process samples and finished product.
Manufacturing & batch records 6
Approved masters drive every batch: plan, dispense, execute and pack under enforced controls.
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Master Formula & Batch Record Design
Versioned formulas, process steps and product definitions — prepared, reviewed and approved by three different people.
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Production Planning & MRP
Production orders released only after a readiness and material-feasibility check on released stock.
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Dispensing & Weighing
Only QA-released lots, only calibrated scales — and every weight verified by a second person.
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Packaging & Reconciliation
Bulk hold-time control, packaging orders and printed-component reconciliation before completion.
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Hybrid (Paper + Electronic) Batch Record
Controlled paper copies, printed once and reconciled before the batch can close.
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Continued Process Verification
Trend process parameters across batches with Cp/Cpk and ±3σ control limits, approved and signed.
Sterile & Annex 1 4
Covers the Annex 1 controls — and blocks a sterile step when the room, line or operator is not ready.
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Aseptic Process Simulation (Media Fill)
Versioned media-fill protocols and runs; a line without a current passing media fill cannot fill.
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Sterilisation Cycles & Filter Integrity
Cycles with BI/CI results and filter integrity tests; a failed cycle cannot be released.
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Contamination Control Strategy
The site CCS, versioned and signed, with a hazard → control → monitoring register.
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Pharma Utilities Monitoring
WFI, clean steam, compressed air and HVAC results classified against versioned alert and action limits.
Materials, release & distribution 3
Only qualified sources in, only released stock out — and every lot traceable both ways.
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GMP Warehouse & Materials Management
Goods receipt into quarantine, sampling and QA release — only released stock can be issued.
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Approved Supplier List & GMP Procurement
Purchase orders only from approved, in-date sources with a quality agreement in force.
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Distribution, Traceability & Recall
Ship only released lots, trace any lot forward or back in one click, and run recalls to closure.
In every module
The compliance controls every module inherits.
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Complete audit trail
Old value, new value, user, time and reason — for every change, in every module.
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Electronic signatures
Password, or password plus a one-time code — set per module and per site.
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Segregation of duties
The person who prepares a record cannot approve or release it.
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Role-based access
A permission matrix controls every action, per site.
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.