Documents & TrainingTraining Management

GMP training management software tied to the SOP in force.

Swat iQua Suite GMP training management software builds every training from an approved, effective SOP version. Trainees read and accept the SOP, complete a server-graded assessment and receive a certificate — and when a new SOP version arrives, the old training is superseded.

  • Created only from effective SOP versions
  • Read-and-accept training records
  • Certificates with the trainee’s designation
  • Training interlocks on the shop floor

Participant journey

From assigned to trained and certified.

Each participant moves Assigned → Read-Accepted → Assessment → Passed or Failed. A participant who uses up their attempts is Blocked until unblocked with a reason.

  1. AssignSOP version

    Assigned

    Internal users are assigned training on a specific effective SOP version.

    Assigned
  2. ReadRead & understood

    Read-accepted

    The trainee reads the SOP and records acceptance in the system.

    Read-accepted
  3. AssessServer-graded

    Assessment

    Graded on the server against a pass mark and attempt limit frozen for that participant.

    In progress
  4. CertifyPDF certificate

    Passed

    A certificate records the trainee’s designation at completion.

    Passed

Unblocking a participant requires a reason and keeps the full attempt history.

Key capabilities

Training records pharma inspectors can trust.

  • SOP-based by design

    A training can only be created from an approved, effective SOP version — never from a draft.

  • SOP read-and-understood

    Each participant records reading and accepting the SOP before completing the training.

  • Fair, fixed rules

    Assessments are graded on the server. Pass mark and attempt limit are set per site and frozen per participant, so past results never change.

  • Certificates and reports

    A PDF certificate shows the trainee’s designation at completion. Results report and export.

  • Supersede handling

    When a new SOP version becomes effective, training on the old version is superseded.

  • Global SOPs across sites

    Training for global SOPs can be copied across sites. Included in the daily overdue digest.

How it works

Training that follows the document — and guards the work.

Training Management in Swat iQua Suite is not a general learning management system. It does one job for GMP: prove that each person was trained on the version of the SOP in force before they did the work it covers.

Built from the SOP in force

When an SOP becomes effective in SOP & Document Control, it prompts the creation of a training. Training can only be created from an approved, effective SOP version, so the training record always points to a controlled document. When a newer version of the SOP takes effect, training on the previous version is superseded.

Read, accept, assess

Trainees read and accept the SOP, then complete an assessment. Grading happens entirely on the server, the answers are never sent to the browser and the time limit is enforced by the server. The pass mark and number of attempts are set per site and frozen for each participant when they are assigned, so changing the site settings later never alters a past result.

Training interlocks on the shop floor

  • A batch step in the electronic batch record cannot start unless the operator is trained on the SOPs linked to that step.
  • Dispensing checks training for both the dispenser and the verifier.
  • Packaging checks training at start and completion.

These interlocks are what turn a training record into a control. Training due dates appear on the compliance calendar and in the daily overdue digest, and only internal users can be training participants.

Regulations

Designed to support GMP training requirements.

  • US FDA cGMP

    Personnel trained in the operations they perform and the written procedures that apply — see 21 CFR 211.25.

    FDA cGMP
  • WHO GMP · Revised Schedule M

    Documented, ongoing training of personnel, with records kept.

    WHO GMP
  • 21 CFR Part 11

    Attributable training records with a complete audit trail.

    21 CFR Part 11

FAQ

Frequently asked questions

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

What is GMP training management software?

Software that records who was trained on which controlled procedure, when, and with what result. Swat iQua Suite creates training from effective SOP versions and records read-and-accept, assessment results and certificates.

Is Swat iQua Suite a general LMS?

No. Training Management is focused on SOP-based and refresher GMP training. It is not designed for general courses or e-learning content.

What happens when an SOP is revised?

When the new version becomes effective, training on the old version is superseded, and a new training is created from the new version.

Does training block untrained operators?

Yes. Batch steps, dispensing and packaging check that the person is trained on the linked SOPs before work can start.

Can external users be trained?

No. Only internal users can be training participants.

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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