For heads of QALinked · tracked · closed on time

Software for pharma QA heads who would rather open the system than prepare for inspection.

Every deviation, CAPA and change linked, tracked and closed on time, with a full audit trail. Swat iQua Suite gives heads of QA one QA dashboard across sites, segregation of duties the system enforces, and release decisions built on evidence.

  • QA dashboard and Action Center
  • One CAPA register fed by every source
  • Segregation of duties in 25 modules
  • Inspection evidence packages in minutes
Dashboard with counts of open CAPAs, deviations, change controls and OOS investigations

Your quality system

Every quality record, linked to the next.

Deviations, OOS results, audits, stability failures and audit-trail findings all escalate into one CAPA register — and CAPA approval follows the source record’s approval chain.

  • CAPA hub

    Standalone or source-raised CAPAs, per-action verification, controlled extensions and an optional effectiveness review.

    • Overdue gate blocks final close
    • Daily overdue digest
    CAPA management
  • Deviations

    Four-person segregation of duties from initiator to decision-taker, with interim close and verified actions.

    • Raised automatically from shop-floor and lab events
    Deviation management
  • Change control

    The same four-person chain with change actions, forward-only extensions and an effectiveness review after closure.

    Change control
  • Audits

    Internal, external and partner audits; each observation can raise its own CAPA, approved with the audit.

    Audit management
  • Supplier qualification

    Assessment plans, site risk ratings that drive audit frequency, and versioned quality agreements.

    Supplier qualification
  • SOPs & training

    SOPs approved and made effective separately; training created from the effective version with server-graded exams.

    Documents & training

Quality KPIs at a glance

See what is open, overdue and blocked — before anyone asks.

A head of QA spends too much time finding out where things stand. In Swat iQua Suite the role-based dashboard does that for you. The Action Center lists pending work oldest first, with scopes for your own items, your team, your site and approvals across modules and sites. Due panels show CAPAs, deviations, change controls, instruments, stability and training, with an overdue-by-owner view so you know who to call.

Every due date from 13 sources — CAPA, deviation and change-control actions, audits, training, supplier assessments, instrument calibrations, stability pulls and more — sits on one compliance calendar. Email digests remind owners before items go overdue, routed per site.

Data integrity you can demonstrate

Periodic audit trail review is built in. When a review starts, five risk signals are frozen for the reviewer: deletions and voids, privileged administrator changes, configuration changes, after-hours activity and — flagged as critical — changes made after approval. Findings can raise a CAPA, and the review is approved with an e-signature by someone other than the reviewer.

Annual product quality review

Product quality reviews collect batch, deviation, CAPA, OOS, change control and EM excursion figures for the review period into a snapshot that cannot be changed, followed by e-signed approval and a controlled PDF.

Segregation of duties is enforced on the server in 25 modules, and most quality workflows have no administrator bypass. Where an override is permitted, it is recorded and shown on the record and its print.

Inspection readiness

When inspectors arrive, you open the system.

Inspection dossiers are assembled from the evidence framework: the system works out completeness, approval is e-signed by someone other than the preparer, and the export carries a SHA-256 checksum manifest so tampering is evident.

  • Evidence completeness — computed by the system, never typed in.
  • Critical gaps block decisions — even an administrator cannot release past one.
  • Expiring exceptions — approved under QA authority, and blocked again automatically when they expire.
  • Trusted time — every entry time-stamped centrally and shown in the site’s local time.
Inspection readiness
Release dossier with evidence items and reviewer sign-offs

From a QA perspective

Inspection-ready by design.

“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

FAQ

Frequently asked questions

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

Can I see open and overdue items across all our sites?

Yes. The Action Center has mine, team, site and approvals scopes across modules and sites, and due panels show overdue items by owner. What each user sees follows their roles at each site.

Does change control raise CAPAs?

No. Change control has its own change actions, verification and effectiveness review. CAPAs are raised from deviations, OOS investigations, lab quality events, audits, stability and audit trail review.

Can someone approve their own record?

No. Segregation of duties is checked on the server — for example preparer ≠ reviewer ≠ approver — and most quality workflows have no administrator bypass.

How quickly can we produce evidence for an inspector?

Inspection dossiers are assembled from existing records, with completeness worked out by the system, and approved dossiers export with a checksum manifest — typically in minutes rather than days of searching.

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 →