Wellthinic Technology, as a service provider that focuses on implementing the overall solutions of automation control and digitization for the pharmaceutical and batch process industries, combines the best industry practices with global leading technical standards to provide comprehensive consulting services for customers.

Features

• Digital Blueprint Planning and Implementation

Design a digital architecture that meets the standards in the early stage of factory construction, renovation, and system upgrading. With years of technical experience and benchmark industry cases, we help customers shorten the project cycle and achieve value delivery.

• Lean Management and Continuous Improvement

Conduct professional investigations and gap analyses, clarify the gap between the current digital level of the enterprise and its goals, provide feasibility reports, customize targeted improvement plans, and promote the continuous development of the enterprise.

• Compliance Assurance and Integration

Ensure that the system design and implementation meet regulatory requirements such as GMP, reducing the audit risk. Through the deep integration technology of IT and OT, create a modular, flexible, safe, and sustainable production model.

• IT Compliance and Audit (for Pharma)

Conduct compliance audits and gap analyses for GxP critical systems (such as electronic records and signatures, data integrity). Assist enterprises in dealing with official inspections such as those from the FDA and EU GMP, and provide pre-inspection simulation and defect rectification support.

• Data Integrity Management (for Pharma)

Evaluate the risks in the data lifecycle and formulate data governance strategies under the ALCOA+ principle. Provide consulting services for electronic data backup, audit trail configuration, and permission management.

•Training and Knowledge Transfer (for Pharma)

Provide customized training for enterprise employees on topics such as GAMP5, data integrity, and computer system validation. Output standardized SOPs and operation manuals to ensure the continuous internalization of technical capabilities.