>> Feasibility Study
YANZ provides feasibility study service for project technical solutions and user requirements before formal engineering to clients and all conclusions will be summarized into a Project User Requirements Specification (PURS). The study includes but not limited to below:
    > Project Master Schedule;
    > Project Scope;
    > Master Plan Overall Planning;
    > Materials Plan, Products Plan; 
    > Process Plan, Equipment’s Plan;
    > IT & Automation Plan;
    > Staffing Plan;
    > Project Phasing Plan;
    > References and Standards;
    > Energy Saving, EHS Requirements;

>> Engineering Design
YANZ provides engineering design service for Greenfield Project, Renovation & Expansion Project which includes but not limited to Schematic Design, Conceptual Design and Basic Design, also include the detailed design for some core packages for example Process Equipment, Logistics Equipment, Lab Equipment, Clean Room, SCADA, PCS, BMS, EMS.

The engineering scope from YANZ are flexible depend on client needs for example to develop some packages for change control, authority submission, tendering etc. If required, YANZ also can help clients to prepare As-Built Drawing for their self-managed projects.

The core members of our design team are YANZ partners, they are from international engineering companies or well-known Local Design Institutes(LDI) and all are industry elites. To approach the best engineering solutions, YANZ also can involve our international partners into the design work if clients required.

Up to now, our team already completes the project for example OSD, sterile preparations, API, IVD, mAb, vaccines and dairy for the clients which include MSD,BASF, Roche, Biolake, CCPC etc.

>> Design Review
With ability across Conceptual Engineering, Basic Engineering, Detail Engineering and Vendor Engineering YANZ can integrate into the client design process at any stage to offer design review service alongside full design for Architecture, HVAC, Mechanical, Electrical and Process systems.

Except all design drawings and documents will be checked and reviewed by senior engineers, the whole review progress will be driven by standard checklist also to guarantee performance. Finally, all comments or observations will be documented into a summary report which based on standard template also to satisfy authority audit requirement.

Strict management procedures are implemented by our engineers to protect clients’ Know-How from leakage.

>> Procurement Support
YANZ provides procurement support service alongside project execution for example to define package scope and boundary, define vendor deliverables, to prepare procurement standards, request for quotation etc. If required, YANZ also can be involved into technical bidding progress for example to prepare evaluation report, technical clarification etc.

>> Vendor Support
To help Chinese vendor improve their international market competitiveness, YANZ provides software upgrading service to the equipment manufacturing enterprises for Pharmaceutical & Medical, Chemical and Food industry. By compiling of below engineering drawings & documents, we provide clients a whole set of internationally recognized technical package:
    > User Requirements Specifications (URS);
    > Process Flow Diagram (PFD), Process & Instrument Diagram (P&ID);
    > Datasheet, Technical Specification;
    > Instruments List, Components List;
    > Critical Assessment (CA), Failure Mode and Effects Analysis (FMEA);
    > Spare Parts List, Operation & Maintenance Manual; 
    > Function, Hardware and Software Design Specification (FDS, HDS and TDS);
    > Project Quality Plan (PQP), Inspection & Test Plan (ITP);
    > Factory Acceptance Test (FAT), Site Acceptance Test (SAT);
    > Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ);

>> Project Management
YANZ provides project management service across the whole project life cycle which incudes but not limited to Design Management, Procurement Management, Construction Management, Start-up & Commissioning Management and Qualification & Validation Management. The detailed service scope from YANZ are flexible depend on client expectation, if necessary, YANZ also can integrate into clients team to implement some subdivisional work for example project planning, document management, schedule control, site management etc.

By accumulating from many projects, YANZ has established a whole set of internationally recognized Project Management Systems, Standard Operation Procedures, Quality Assurance & Control Systems and Application Templates. Besides, our team members for example Project Managers, Discipline Engineers, Schedulers and Document Controllers are Medical & Pharmaceutical, Chemical, Food or Engineering backgrounded, all are highly-experienced and GEP trained.

Detailed schedules, meticulous solutions and judicious decisions are the weapons of YANZ to manage project. Rely on our smart system and professional team, YANZ promise clients to delivery project as user expectations and regulatory requirements by continuous monitoring & control of project key performances for example “Safety”, “Schedule”, “Quality”, “Cost” and “Risk” etc.

① Construction Management
YANZ provides construction management service alongside project execution which includes but not limited to help clients handle below tasks:
    > Establish site management and operation procedures;
    > Establish overall construction plan and schedule;
    > Establish project quality execution plan & schedule;
    > Documents control, schedules control;
    > Subcontracts coordination, routine meetings organization;
    > Review and approve construction protocols, change requests from subcontractors;
    > Site walkdown, coordination and non-conformances management;
    > Initial of Construction completion, mechanical completion, punch list management;
    > Review and approve construction & mechanical completion handover packages;
Through detailed inspection & test actions, YANZ provides documented evidences to clients that all packages & sub systems are built & installed as per user and regulatory requirements by compiling of Construction Completion Packs or Mechanical Completion Packs. 

② Commissioning Management
YANZ provides commissioning management service alongside project execution which includes but not limited to help clients handle below tasks:
    > Establish site management and operation procedures;
    > Establish overall start-up & commissioning plan and schedule;
    > Establish project quality execution plan & schedule;
    > Documents control, schedule control;
    > Cross system coordination, routine meetings organization; 
    > Review and approve start-up & commissioning protocols, change requests;
    > Site walkdown, coordination;
    > Review and approve start-up & commissioning reports, punch list management;
    > Organization of equipment operation & maintenance training;
    > Review and approve system commissioning completion handover packages;
Through detailed start-up & commissioning actions, YANZ provides documented evidences to clients that all systems & equipment’s are commissioned and their operation can meet user and regulatory requirements by compiling of System Commissioning Packs.

>> Validation
Dedicated for Pharmaceutical & Medical industry, YANZ provides validation service across the whole product life cycle which includes but not limited to Clean Room, HVAC, Environmental Monitoring System, Process Equipment, Computerized System, Production Process, Cleaning and Analysis Methods etc.

To approach the audit from different authorities, YANZ has established a whole set of internationally recognized validation templates for example Management SOP, Document Requirement Matrix, GMP Review Checklist, Validation Plan, User Requirements Specification, Technical Specifications, Critical Assessment Form, Failure Mode and Effects Analysis Form, Validation Protocols and Reports etc.

Different from other companies which being mainly consisted of quality personnel, most of our validation specialists are engineering backgrounded, all are highly technical experienced and GxP trained. Thus, our validation service not only provides the assurance that all systems are satisfied with regulatory and user requirements, but also help clients find and solve problems technically.

Start from project conceptual design and ended with plant trial production, the deliverables from our validation service include but not limited to below documents:
    > Validation Management SOPs;
    > Conceptual, Basic and Detailed Design GMP Review Report;
    > System List, System GMP Impact Assessment Form; 
    > All kinds of validation master plans, validation plans and schedules;
    > User Requirements Specifications, Technical Specifications;
    > Critical Assessment (CA), Failure Mode and Effects Analysis (FMEA); 
    > Validation Document Matrix, Requirements Tracing Matrix;
    > FAT & SAT Protocol and Report;
    > Design, Installation, Operation and Performance Qualification Protocols and Reports;
    > Process, Cleaning Validation Protocols and Reports;