Swat iQua Suite covers the GMP-controlled side of the supply chain: supplier approval, purchasing, receipt, sampling, material release, warehouse status, production planning, dispensing, distribution and recall. Every movement carries the same audit trail, e-signatures and segregation of duties as the quality and laboratory records it depends on.
Scope, stated plainly
- Covered: approved supplier list and GMP procurement, goods receipt and quarantine, sampling plans, QA material release, inventory ledger and locations, production planning and material availability, dispensing, packaging, shipments of released stock, traceability and recall
- Not covered: sales orders, invoicing, costing, CRM and general accounting — these stay in your finance system
Approved Supplier List and GMP procurement
Each site keeps an Approved Supplier List per material, naming both the supplier’s dispatch site and the manufacturer’s site. A purchase order line can only use a source that passes the gate on the PO date: the ASL entry approved and in date, the qualification scope effective, the quality agreement in force, and a valid GMP certificate and verified capability at the manufacturer’s site. The gate is checked when the line is added and again for every line at approval, and PO approval is e-signed with segregation of duties. Sources past their approved-to date expire automatically.
Warehouse: quarantine to release
Material enters only through a posted goods receipt against an approved PO line, landing as a quarantine lot in a quarantine location. Lots move through a 12-state status model — from quarantine, sampling pending and under testing to unrestricted, with conditionally released, on hold, under investigation, retest due, expired, rejected, returned and destroyed — and illegal status jumps are refused. Only unrestricted stock can be reserved or dispensed. The inventory ledger is immutable: corrections are reversal entries, and balances can never go negative.
At receipt the system decides the testing level — full, reduced or identity-only — from the manufacturer site’s qualification and its run of consecutive conforming lots, and resets it after an OOS or deviation. Identity is always tested, in line with 21 CFR 211.84. Supplier CoAs and receipt documents are stored privately with a SHA-256 integrity check on download, and QA material release needs a conforming CoA, a passed identity test, all QC tests approved and no OOS — signed by someone who neither received nor tested the lot.
