SaaS System Validation Project for Global Pharmaceutical Group

Project Background

The client is a Suzhou subsidiary of a multinational pharmaceutical company. The SaaS cloud system manages the purchase, sales, and inventory (PSI) of pharmaceuticals and medical devices. This project aims to verify that the system meets national regulatory requirements for the distribution of pharmaceuticals and medical devices.

Scope of Services

Coordinates with the Four Parties and performs on-site validation, including Dry Run Test and formal test. Dry Run finalizes test protocols, covering script testing, IQ/OQ/PQ, RTM and VSR.

(Note: Four Parties: AUSTAR Consulting (US)/ The Medical Technology (Suzhou) Co., Ltd. (end user)/ Shanghai-based software implementer/ AUSTAR Compliance Consulting Team (validation executor)

AUSTAR Value & Client Benefits

• Full project management meeting MNC standards.

• Professional cloud validation ensuring computerized system & data integrity compliance.

• Smooth system launch with aligned design, configuration and validation.