Quality · eQMSSupplier & Vendor Qualification

Supplier qualification software that purchasing cannot get around.

Swat iQua Suite supplier qualification software runs a per-site assessment programme for suppliers, service providers and subcontractors — with qualification scopes, site risk assessments and versioned quality agreements. Only a supplier with an approved quality agreement in force passes the approved-source check on a purchase order.

  • Planned assessments created automatically
  • Single, double or dual-person signatures
  • Versioned quality agreements
  • Expiry digest at 30 and 7 days

Real product footage

Watch a purchase order approved by QA.

Assessment lifecycle

From a planned assessment to an effective qualification.

Scheduled / Planned → In Progress → Submitted → Under Review → Effective or Rejected. An effective assessment later becomes Expired by date or Superseded by a re-assessment.

  1. PlanDaily spin-up

    Scheduled

    Per-site assessment plans create scheduled assessments automatically, onto each assessor’s worklist.

    Scheduled
  2. PerformPerformed

    In progress & submitted

    The assessor records the assessment and signs it as performed.

    Submitted
  3. ReviewReviewed · approved

    Under review

    Reviewed and approved by different people — with a co-signer where the site uses dual-person signing.

    Under review
  4. EffectiveCertificate

    Effective

    The qualification is in force until it expires or is superseded; a PDF certificate carries the signature manifest.

    Effective

Extension requests change the due date only when approved — overdue work is blocked until then.

Key capabilities

Vendor qualification as a controlled programme.

  • Plans and worklists

    Configurable assessment types and per-site plans. A daily job creates scheduled assessments, and each user has a “My Assessments” worklist.

  • Signature modes per site

    Single, double password or dual-person signing. Signatures cannot be changed, are tied to an assessment version and freeze the signer’s name and designation.

  • Four-way SoD

    Performer ≠ reviewer ≠ approver ≠ co-signer, checked on the server.

  • Qualification scopes

    Qualify a supplier by material, product, category, dosage form, service or market — each scope with its own risk rating.

  • Site risk assessments

    Supplier site risk ratings drive how often each site should be audited.

  • Versioned quality agreements

    Quality agreements are prepared, reviewed and approved as versions; the approved version must be in force on the PO date.

How it works

Approved vendor assessment that reaches all the way to the purchase order.

Supplier qualification only protects a plant if purchasing respects it. In Swat iQua Suite the qualification programme feeds the approved-source check in GMP procurement: a purchase order passes only when the supplier is qualified and an approved quality agreement version is in force on the PO date.

A per-site programme

Each site runs its own assessment programme for its business associates — suppliers, service providers and subcontractors. Assessment types are configurable, and per-site plans let a daily job create the next scheduled assessments automatically. The last and next assessment dates are written back to the business associate record, so purchasing and QA always see the same status.

Signatures that hold up

Every signature — performed, reviewed, approved and co-approved — is tied to a specific assessment version and cannot be changed afterwards. The signer’s name and designation are frozen at the moment of signing, so a later promotion or role change never rewrites history. Sites choose single, double-password or dual-person signing to match their procedure.

Staying in date

  • A daily expiry digest lists items already expired and items due within 7 or 30 days.
  • Extension requests change the effective due date only after approval; until then, a hard overdue gate blocks late work.
  • An effective assessment becomes Expired automatically from its dates, or Superseded when a re-assessment takes over.

Reporting

A dashboard, Excel export and PDF report show the programme status across suppliers. Each qualification can produce a PDF certificate with a signature manifest showing who signed, in what role, with what meaning and when. Supplier audits themselves are recorded in Audit Management, with one CAPA per observation.

Regulations

Designed to support supplier control requirements.

  • 21 CFR Part 11

    Signature manifestation with name, role, meaning and date — §11.50 — on assessments and certificates.

    21 CFR Part 11
  • EU GMP Chapter 7

    Outsourced activities governed by written, approved agreements between contract giver and acceptor.

    PIC/S & EU GMP
  • US FDA cGMP

    Components accepted only from qualified suppliers, with the qualification documented — see 21 CFR 211.84.

    FDA cGMP

FAQ

Frequently asked questions

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

What does supplier qualification software do?

It manages the assessment, approval and periodic re-assessment of suppliers and service providers. In Swat iQua Suite it also holds qualification scopes, site risk assessments and versioned quality agreements, and feeds the approved-source check on purchase orders.

Can we require two signatures on an assessment?

Yes. Each site chooses single, double-password or dual-person signing, where a separate co-signer approves. Performer, reviewer, approver and co-signer must all be different people.

How are quality agreements controlled?

Quality agreements are versioned and go through prepare, review and approve. The approved version must be in force on the purchase order date for the supplier to pass the approved-source check.

How do we know when qualifications are about to expire?

A daily email digest lists items already expired and items due within 7 or 30 days. Expired status is derived from the dates automatically.

Is it set up per site?

Yes. Each site runs its own assessment plans, signature mode and worklists.

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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