Pharma document management software where every SOP drives its training.

The SOP lifecycle

SOPs in Swat iQua Suite move from draft to review, approval and a separate make-effective step. Approval does not put an SOP into use on its own: an approved SOP waits “awaiting go-live” until someone deliberately makes it effective, so the date it takes effect is a recorded decision. Editing an effective SOP reopens the workflow, and each approval moves the version on.

Segregation of duties is enforced by the server — the reviewer cannot be the author, and the approver cannot be the author or the reviewer — with no administrator bypass. The signature block shows each signer’s designation at the time they acted, not their current job title.

Controlled copies that cannot drift

When an SOP is made effective, a controlled-copy PDF is saved and can never be changed. Reprints use that saved copy rather than regenerating it, so the document an inspector sees is the document that was approved. A watermarked preview is available before approval, and reference numbers follow your departments.

Global SOPs across sites

Group-wide procedures can be shared across sites as global SOPs, with their trainings copied to each site, while site-specific SOPs stay local.

Swat iQua Suite controls SOPs and the training that follows them. It is not a general learning management system — every training starts from an effective SOP version.

Read, accept, prove

A training can only be created from an approved, effective SOP version. Participants read and accept the SOP, then sit an exam that is graded entirely on the server — the answer key is never sent to the browser, and the 20-minute deadline is enforced by the server too. Pass mark and attempt limit are set per site and frozen for each participant, so changing the settings later never alters a past result.

• Participants who use up their attempts are blocked; unblocking needs a recorded reason and keeps the attempt history
• PDF certificates show the trainee’s designation at completion
• Results report and export for QA and auditors
• Overdue trainings included in the daily reminder digest
• Only internal users can be training participants

Training that gates the work

The real test of a training system is whether untrained people can still do the job. In Swat iQua Suite they cannot: a batch step will not start unless the operator is trained on the SOPs linked to it, and dispensing checks training for both the dispenser and the verifier. Packaging start and completion carry the same interlock.

Product and process knowledge

Alongside SOPs, product knowledge items capture critical quality attributes and critical process parameters — with target, limits, rationale and source reference — tied to the exact product version they come from. Approval is e-signed with segregation of duties, approved items cannot be edited, and a correction is a new draft that supersedes the old item once approved.