A CSA requirement and traceability register
Swat iQua Suite includes a controlled register of system requirements, built for a computer software assurance (CSA) approach. Each requirement carries a risk level, is approved with an e-signature by someone other than its owner, and cannot be edited once approved — a controlled correction replaces it with a new version and keeps the original. Requirements trace through to test cases and their execution, and a coverage report shows which approved requirements have a verified execution and which still have gaps.
Validation support from people who know the system
Implementation starts by mapping your processes, forms and SOPs, then configuring sites, roles, workflows and master data. We support your validation with documentation and the traceability register, and stay with you through go-live. Your quality unit keeps ownership of the validation decision — as GAMP 5 and every regulator expect.
Risk-based by design
Swat iQua Suite follows a GAMP 5 risk-based validation approach and ALCOA+ data-integrity principles. Because e-signature levels are set per module and per site, and modules can be switched on in phases, you can scope each validation step to what is actually going live.
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. Compliance is achieved by your validated installation and procedures, which we help you put in place.
