Royal Quality Pillars
Turnkey Project Services
Empower your quality operations with a secure, compliant, and integrated platform designed for regulated industries.
Key Features
1. Project Initiation & Feasibility
- Project Planning & Feasibility Study
- Land Selection
- Regulatory Feasibility Assessment
- Risk Assessment & Mitigation Plan
2. Design Phase
- Factory Layout Design
- Concept & Civil Design
- Process Engineering
- 3D Modelling / BIM
3. Cleanroom & Environment Systems
- Modular Cleanroom Panels
- HVAC Design
- EMS (Environmental Monitoring System)
- BMS (Building Management System)
- Pressure Zoning Plan
- Airflow Visualization & Smoke Studies
- Cleanroom Classification & Validation Plan
4. Engineering Utilities & Infrastructure
- Electrical & Extra Low Voltage Systems
- Utilities (WFI, PW, Steam, Compressed Air, Nitrogen, HVAC)
- Mechanical Engineering Design
- Machinery Selection and Design
- Firefighting Design
- Environmental Engineering Design
- Utility Piping & Instrumentation Design (P&ID)
- BOQ Preparation for Procurement
5. Construction & Execution
- Civil Construction & Supervision
- MEP (Mechanical, Electrical, Plumbing) Execution
- Cleanroom Installation & Commissioning
- Equipment Installation & Calibration
- Utility Validation (Thermal Mapping, Pressure Testing, etc.)
6. Automation, Software & CSV
- Implementation of Software Systems
- Computer System Validations (CSV)
- Automation Design (SCADA/DCS/HMI)
- 21 CFR Part 11 Compliance Setup
- Cybersecurity Setup for Networked Systems
7. Validation & Quality System Implementation
- Validation & Qualifications (DQ, IQ, OQ, PQ)
- Documentation Support Services
- Implementation of Quality Systems (QMS, SOPs)
- Change Control & Deviation Management Setup
- Continual Validation Plan (Requalification/Periodic Review)
8. Laboratory Setup
- QC Laboratory Design & Setup
- Microbiology Lab Setup
- Lab Equipment Selection & Validation
- GLP Compliance Assessment
9. Regulatory Support & Commercial Readiness
- Dossier Service (CTD/eCTD preparation)
- Export Marketing Services
- Regulatory Audit Support (e.g., USFDA, EU-GMP, WHO)
- Mock Inspection & GAP Analysis
- Product Registration & Licensing Support
10. Post-Commissioning Support
- Operator & Maintenance Staff Training
- Annual Maintenance Contract (AMC) Support Setup
- SOP Training & Document Handover
- Post-Go-Live Technical Support / Warranty Support