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ComplianceOne evidence trail for every market

GMP compliance software for pharma — one set of controls, every inspector.

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. Choose your regulation to see exactly which controls support it.

  • Complete audit trail with a reason for every change
  • 3 e-signature levels, set per module
  • Segregation of duties in 25 modules
  • Evidence packages for FDA, MHRA and EMA inspections
Book a free demo Security & access
QC analysts working at laboratory instruments in a GMP laboratory
7
regulations & standards designed to comply with
3
e-signature levels
25
modules with enforced segregation of duties
85+
integrated modules

Read this first

“Designed to comply with” — and why we say it that way.

No software is compliant on its own. Compliance is something your organisation demonstrates, with a validated installation, your procedures and trained people. What the software can do is make the right thing the easy thing — and the wrong thing impossible.

Regulators inspect manufacturers, not software vendors. When an FDA investigator, an MHRA inspector or a CDSCO team reviews your computerised systems, they ask how you validated the system for its intended use, how you control access, how you review audit trails and how your people are trained. A vendor that calls its product “fully compliant” or “validated” is claiming something it cannot deliver on your behalf.

So we describe Swat iQua Suite precisely. It is designed to comply with the regulations listed on these pages: the technical controls those regulations expect — audit trails, electronic signatures, access control, segregation of duties, trusted time, controlled records — are built into the platform and enforced on the server. Every module inherits them, so a new module arrives with the same controls as the rest.

What you can rely on the platform for

  • Every write and its audit-trail entry commit together, with old and new values, the user, the time and a mandatory reason for the change.
  • Electronic signatures that re-authenticate the signer, configured per module and per site, with the signer’s name, designation and meaning recorded.
  • Segregation of duties enforced on the server — the preparer cannot review, the reviewer cannot approve, and the person who ran the batch cannot release it.
  • Approved masters that are versioned, so every downstream record knows which specification, formula or SOP version applied.
  • Release decisions that are blocked while critical evidence is missing, and inspection evidence packages sealed with a checksum manifest.

What stays with you

Validation of your installation for its intended use, your SOPs for using and administering the system, user training, periodic review of audit trails and access, and the decisions your quality unit takes. We support your validation with requirements traceability in the CSA register, evidence of the Part 11 controls and our team working alongside your QA and CSV leads — but the validated state belongs to your organisation, for your installation.

One evidence trail for every market — FDA, MHRA, EMA, CDSCO and WHO inspections from the same records.

Global

Standards that apply wherever you sell.

Data integrity and computerised-system principles that inspectors in every region expect — and the GMP guides shared by many national regulators.

  • 21 CFR Part 11

    The FDA rule for electronic records and electronic signatures — audit trails, access, signature manifestation and linking.

    Part 11 controls

  • ALCOA+

    Attributable, legible, contemporaneous, original, accurate — plus complete, consistent, enduring and available.

    ALCOA+ principles

  • GAMP 5

    ISPE’s risk-based approach to computerised system validation, and how we support yours.

    GAMP 5 approach

  • PIC/S GMP

    The harmonised GMP guide used by inspectorates worldwide, with its own data integrity guidance.

    PIC/S GMP

  • WHO GMP

    The GMP baseline for WHO prequalification and for many regulators in Africa and emerging markets.

    WHO GMP

US · UK & EU

FDA, EMA and MHRA expectations, mapped.

The regulations behind FDA, EU and UK inspections — from batch records and laboratory controls to computerised systems and sterile manufacturing.

  • US — FDA cGMP

    21 CFR 210 and 211: component control, production records, laboratory controls and record review.

    FDA cGMP

  • UK & EU — Annex 11

    Computerised systems under EU GMP: data, audit trails, security, e-signatures and batch release.

    Annex 11

  • UK & EU — Annex 1

    Sterile manufacturing: the contamination control strategy, media fills, sterilisation and monitoring.

    Annex 1

  • UK — MHRA data integrity

    The MHRA GxP data integrity guidance: data governance, audit trail review and hybrid systems.

    MHRA data integrity

India · Middle East

Regional GMP, from the same records.

National GMP rules increasingly converge on the same international guides — so the same platform controls serve each of them.

  • India — Revised Schedule M

    India’s revised GMP schedule under the Drugs and Cosmetics Rules — now in force for every manufacturer, large or small.

    • Pharmaceutical quality system and quality risk management
    • Product quality review, change control and supplier qualification
    Revised Schedule M

  • Middle East — GCC GMP

    GMP expectations across the Gulf, which draw on internationally harmonised guides such as PIC/S and WHO GMP.

    • The same controls that support EU GMP and Annex 11
    • One evidence trail for every market you supply
    GCC GMP

Shared foundation

The controls behind every regulation on this page.

Whichever regulation you are inspected against, the evidence comes from the same platform controls.

  • Complete audit trail

    Old value, new value, user, site, time and a reason for every change — reported across every module, with PDF and Excel export.

  • Electronic signatures

    Password re-authentication at signing, or password plus one-time code, set per module and per site.

  • Segregation of duties

    Enforced on the server in 25 modules. Most quality workflows have no administrator bypass.

  • Trusted time

    Every entry time-stamped centrally and shown in the local time of the site where the work was done.

  • Audit trail review

    Periodic, risk-based review with automatic signals for deletions, admin changes and changes after approval.

  • Inspection evidence

    Records, audit trails and signatures assembled into an evidence package with a SHA-256 checksum manifest.

Designed to comply with

Keep exploring

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FAQ

Frequently asked questions

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

Is Swat iQua Suite validated or certified?

No software is validated or certified for compliance on its own. Validation is performed by the regulated company for its installation and intended use. 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, and we support your validation with requirements traceability and evidence of the controls.

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.

We supply several markets. Do we need different systems?

No. The same audit trail, signatures, segregation of duties and controlled records support FDA, MHRA, EMA, CDSCO and WHO inspections. Regional rules differ in emphasis, not in the evidence a well-controlled system produces.

What about PIC/S and GCC GMP?

Both build on internationally harmonised GMP. PIC/S shares its GMP guide, including Annex 11 and Annex 1, with EU GMP, and Gulf regulators draw on these guides and WHO GMP. The controls that support EU GMP and Annex 11 in Swat iQua Suite are the same ones you would rely on there.

Who is responsible for validation, procedures and training?

Your organisation. Validation of your installation, the SOPs for using and administering the system, user training and periodic reviews remain the manufacturer’s responsibility. Our implementation team supports each of them.

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.

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