Global ERP Computerized System Validation
Risk-based CSV of Quasar Medical's enterprise ERP across its manufacturing sites in Israel, Asia, Europe and North America, under GAMP 5, 21 CFR Part 11, EU Annex 11 and ISO 13485.
CSVGAMP 5URS/FSIQ/OQ/PQChange controlPeriodic review
The Brief
Quasar Medical manufactures Class II and Class III medical devices at sites on several continents. Its ERP has to run with full data integrity and one validation approach across time zones, aligned with FDA 21 CFR Part 11, EU Annex 11, GAMP 5 and ISO 13485.
What We Do
- Planning and risk: global ERP Validation Master Plans and risk assessments, classifying functions under GAMP 5 to keep testing lean and defensible.
- Specifications: standardized URS and FS across supply chain, inventory, production planning, quality and batch release.
- Qualification: IQ, OQ and PQ protocols and execution across the sites - workflows, interfaces, electronic signatures, user authorization and audit trails.
- Change control and periodic review: CSV change control for updates, patches and expansions, with Validation Summary Reports.
Result
One harmonized CSV framework across Quasar’s international sites, keeping the ERP audit-ready and product traceability intact.
Planning a Facility, a Line or a Validation?
Tell us what you are building. An engineer will get back to you.