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Pharma QMSOne CAPA register

Pharma QMS software where every quality record links to the next.

Swat iQua Suite is pharma QMS software — an electronic quality management system for manufacturers and QC labs. CAPA, deviations, change control, OOS, audits, risk and supplier qualification share one audit trail, and segregation of duties is enforced by the system, not by trust.

  • CAPA raised from the source record
  • Preparer ≠ reviewer ≠ approver, no admin bypass
  • Daily overdue reminder digests
  • Inspection evidence with a checksum manifest
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Swat iQua Suite dashboard with quality cards for CAPA, deviations, change controls, lab quality events and OOS
25
modules enforce segregation of duties
3
e-signature levels
85+
integrated modules
7
regulations designed for

2-minute product tour

Real screens, real records. See a deviation become a CAPA.

  1. Deviation record DEV/2026/0017 showing title, Major classification, reason for change, department and initiator

    Step 1 of 4Major · Closed

    A deviation, recorded where it happened

    DEV/2026/0017 records a drying time that ran past its validated limit. It is classified Major, linked to its department and raised by a named person.

    1. Classification & status
    2. Raised by a named person
    3. Locked once closed
  2. Deviation decision by the plant head and closure by Head QA, each with name and time-stamp

    Step 2 of 4Decision e-signed

    Decision and closure, each by a different person

    The plant head decides to proceed; Head QA closes the deviation once its actions are complete. Each step shows who acted and when, in the site’s local time.

    1. Decision by the plant head
    2. Closed by Head QA
    3. The rationale, on record
  3. CAPA record raised from an internal audit, with the action, owner, target date, reviewer and approver

    Step 3 of 4CAPA closed

    The CAPA, tracked to closure

    An internal audit finding raised this CAPA. The action has an owner and a target date; a QA officer reviews it and Head QA approves it — two different people.

    1. Source: internal audit
    2. Owner & target date
    3. Reviewed and approved separately
  4. Activity timeline of the deviation listing each event with user, time and old and new values

    Step 4 of 4Audit trail

    Every change on the audit trail

    The activity timeline shows who changed what, when and why — the old and new value of every field, readable by an inspector without a database query.

    1. Each event, user and time
    2. Old value → new value
    3. The decision and its reason

Real product footage

Watch a deviation go from review to approval.

The quality loop

From event to verified closure — in one linked record.

A single CAPA register is fed by deviations, OOS, lab quality events, audits, stability failures and audit-trail review. Approving the source approves its CAPA in the same step — so nothing is approved twice, or not at all.

  1. DeviationDEV/2026/0016

    Event recorded

    Raised from batch execution, an environmental excursion or a raw-data review finding.

    Investigating

  2. CAPACAPA/2026/0042

    CAPA raised and approved

    Approved together with its source — the hub refuses to approve it on its own.

    Open

  3. ActionsVerifier ≠ owner

    Actions verified

    Each action verified by someone other than its owner; overdue actions need an approved extension.

    Verified

  4. ClosureEffectiveness

    Effectiveness review

    An optional effectiveness review before final closure.

    Closed

Every step in the same audit trail — one click from the CAPA back to the event that caused it.

eQMS modules

Nine quality modules. One register of truth.

  • CAPA Management

    One register for corrective and preventive actions, with per-action verification, extensions and an optional effectiveness review.

    CAPA software

  • Deviation Management

    Four different people initiate, review, approve and decide; interim close keeps open actions workable.

    Deviation management

  • Change Control

    Review, approval, verified change actions and an effectiveness review after closure.

    Change control

  • OOS & Lab Incident Investigation

    Up to three investigation levels, each reviewed and approved; finalising locks the record.

    OOS investigation

  • Audit Management

    Internal, external and supplier audits — one CAPA per observation, approved with the audit.

    Audit management

  • Quality Risk Management (FMEA)

    FMEA registers where the server computes RPN from severity, occurrence and detection.

    Risk management

  • Supplier & Vendor Qualification

    Assessment plans, risk-rated scopes and versioned quality agreements, with expiry digests.

    Supplier qualification

  • Audit Trail & Data Integrity

    Cross-module audit-trail report, periodic risk-based review and second-person raw-data review.

    Audit trail review

  • Inspection Readiness

    Dossiers assembled from evidence requirements, approved with an e-signature and a SHA-256 manifest.

    Inspection readiness

Inside the eQMS

What pharma QMS software should enforce — not just record.

Many quality systems store forms. A GMP quality management system has to enforce who may sign what, in which order, and what happens when a date slips.

CAPA as the hub

CAPAs in Swat iQua Suite are raised on their own or from a source record — a deviation, OOS, lab quality event, audit observation, stability failure or audit-trail review finding. A source-raised CAPA is approved through the source’s own approval chain, and the full CAPA work panel — verify, extend, close, review effectiveness — is available from inside the source record. Preparer, reviewer and approver must be different people; an action’s verifier cannot be its owner; an extension cannot be approved by the person who requested it. A hard overdue gate blocks final closure unless an approved extension exists.

Deviations and change control

Deviations and change controls share a four-actor lifecycle: initiator, reviewer, approver and decision-taker must all be different people. An e-signature on approval can be required per site. Actions carry their own verification and forward-only extension requests, and an interim close — with an e-signed justification — lets the record close while its open actions remain workable until final close. Change control adds an effectiveness review after closure, and its corrective mechanism is its own change actions.

OOS and lab incidents

OOS investigations run in up to three levels. Level 1 always runs; the server decides the current level, and each level has its own review and approval. Finalising locks the record, and the controlled print is only available after that. Lab quality events — OOT results, complaints and other incidents — follow the same level-by-level pattern, and both can raise a CAPA that is approved with the final level.

Audits, risk and suppliers

  • Audits: internal, external and partner audits, with each observation able to raise its own CAPA
  • Quality risk management: FMEA registers with RPN computed by the server and recalculated after mitigation, approved by QA with an e-signature
  • Supplier qualification: per-site assessment plans, signature modes up to dual-person, risk-rated qualification scopes and versioned quality agreements that the purchasing gate checks

Daily email digests list overdue deviations, change controls, audits, trainings, CAPAs and pending extension approvals — routed to the right site.

Shared controls

Quality controls your inspector will look for.

  • Complete audit trail

    Old value, new value, user, time, site and a reason for every change — written in the same transaction as the change itself.

  • Segregation of duties

    Enforced in 25 modules, with no administrator bypass on the main quality workflows.

  • E-signatures

    Password, or password plus a one-time code — per module and per site.

  • Reminder digests

    Overdue items and pending approvals emailed daily.

  • Audit-trail review

    Risk-based runs flag deletions, privileged and configuration changes, after-hours activity and changes after approval.

  • REST API

    CAPA, deviation, change control, OOS, audit and training records available through the versioned API.

Product quality review & CPV

Product quality review from the records you already keep.

Because deviations, CAPAs, OOS, change controls and batches live in one system, the periodic review starts from live data instead of a spreadsheet hunt.

The product quality review collects the period’s figures — batches, deviations, CAPAs, OOS investigations, change controls, environmental monitoring excursions and lab quality events — and freezes them as a snapshot that cannot be changed. The review is then prepared, approved with an e-signature by someone other than the preparer, and issued as a controlled PDF report. Modules you have not licensed simply show as not applicable.

The review works at count level today: it gives QA a reliable, reproducible starting point for the APQR or PQR narrative, trend discussion and conclusions your SOP requires.

Continued process verification

For stage 3 process validation, continued process verification trends a process parameter across batches. Your team enters the data points for the review period — each can be tagged to its batch — and on preparation the server calculates mean, standard deviation, Cp and Cpk, ±3σ control limits and out-of-control points into an immutable snapshot, which is then approved with an e-signature.

CPV data points are entered by your team; the calculation, snapshot and approval are controlled by the system.

Inspection readiness

When the inspector arrives, open the system.

Inspection dossiers are assembled from approved evidence requirements, and completeness is calculated by the system. On approval, the dossier export carries a SHA-256 checksum manifest, so any tampering is detectable.

  • Evidence completeness — computed, never typed in.
  • Approval — e-signed, and the approver cannot be the preparer.
  • Checksum manifest — tampered or expired exports are refused.
  • Audit-trail export — PDF and Excel, every export logged.
Inspection readiness
Swat iQua Suite release dossier listing evidence items with their status and named reviewers

Designed to comply with

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.

ARC Pharma UK LimitedUnited Kingdom · QC laboratory, since 2016

“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.

Lunar Labs LimitedUnited Kingdom · QC laboratory

“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.

Norvium Healthcare Pvt. Ltd.India · API manufacturing

Keep exploring

Related

FAQ

Frequently asked questions

Can’t find your answer? Talk to our team — we reply within one business day.

What is pharma QMS software?

An electronic quality management system (eQMS) built for GMP: it runs CAPA, deviations, change control, OOS, audits, risk and supplier qualification as controlled workflows with an audit trail, e-signatures and segregation of duties. In Swat iQua Suite these share one platform with the LIMS and batch records, so quality events link to the batch, sample or instrument they came from.

Which records can raise a CAPA?

Deviations, OOS investigations, lab quality events, internal, external and supplier audit observations, stability failures and audit-trail review findings. A CAPA raised from a source record is approved with that record; standalone CAPAs have their own review and approval.

Can an administrator override segregation of duties?

Not on the main quality workflows. CAPA, deviation, change control, SOP and specification approvals have no administrator bypass — the server refuses the action.

How are overdue items handled?

Daily email digests list overdue deviations, change controls, audits, trainings and CAPAs. Actions past their due date cannot be verified, and a CAPA cannot be finally closed, without an approved extension.

Does it support the annual product quality review?

Yes. The product quality review collects the period’s batch, deviation, CAPA, OOS, change control, EM excursion and lab quality event figures into a frozen snapshot, approved with an e-signature and issued as a controlled PDF — a reproducible basis for your APQR/PQR.

Can we start with QMS only?

Yes. Most customers start with a quality foundation — CAPA, deviations, change control, OOS, audits, SOPs and training — and add the lab, manufacturing and sterile areas later. Licensing is modular, so you pay only for what is live.

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.

Download the brochure →