Compliance & Project Management_TekMax-Cleanroom Integrated Turnkey Solutions

Turnkey solution

Dalian TekMax Technology — Cleanroom Solutions

Compliance & Project Management

Commissioning & Qualification (DQ/IQ/OQ/PQ)

Provide clean project debugging and validation services, covering Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Complete system debugging, document preparation, test execution, and report output, assisting clients in completing GMP validation delivery to meet regulatory compliance requirements.

GMP Validation & Regulatory Compliance Support

Provide full-process GMP validation and compliance technical support, including the preparation of validation plans, implementation of tests, output of validation reports, deviation handling, and assistance in improving the document system. Assist clients in meeting regulatory inspection requirements to ensure the project successfully passes GMP compliance acceptance.

EPC Full-cycle Project Management

Provide clean project EPC full-cycle project management services, coordinating design, procurement, construction, commissioning, and verification at each stage, controlling project schedule, quality, cost, and risk, coordinating multiple resources, and ensuring high-quality project delivery as planned.

Procurement & Quality Management

Carry out project procurement and overall quality management, responsible for equipment and material selection, supplier control, material inspection, and acceptance upon arrival, establishing a project quality control system. Control the quality checkpoints in the supply chain to ensure that all materials and equipment meet cleanliness and GMP standards.

HSE Management (Health, Safety & Environment)

Implement the HSE management system for the project, establish on-site health, safety, and environmental control mechanisms, and carry out operational risk identification, safety control, environmental protection measures, and on-site supervision. Avoid construction safety hazards, fulfill environmental protection requirements, and ensure the safety of personnel, the project, and the environment.