Design and Qualification
Process and product safety is always a priority for us.
We ensure compliance with GxP’s and other official requirements (FDA, EMA, etc.) in accordance with current standards in construction and conversion of entire plants or plant components in the pharmaceutical industry.
We aim for the complete and comprehensible documentation of all GMP-relevant processes or process steps and the assistance of our customers beyond project completion.
An overview of our services:
- Determining qualifiers
- Risk analysis definition
- Qualification schedule generation
- Implementing DQ, IQ, and OQ
- Extending qualification phases with FAT and SAT
- Assisting in PQ
- On-site operator training
- Formulating SOPs
- Change control
Years of experience, continual further training, and know-how in pharmaceutical plant construction ensure that qualification will be treated extensively and with the utmost quality.
- ASSESSMENTS
- RISK MANAGEMENT
- SYSTEM/SOFTWARE QUALITY ASSURANCE PROCESS
- SYSTEM/SOFTWARE CONFIGURATION MANAGMENT PROCESS
- SYSTEM/SOFTWARE PROBLEM RESOLUTION PROCESS
- OPERATIONS AND MAINTENANCE LIFECYCLE
- SYSTEM DISPOSITION/RETIREMENT
FAQ
What compliance standards do you follow?
We ensure full compliance with GxP guidelines and regulatory requirements from authorities such as the FDA, EMA, and other official bodies. Our services are aligned with current pharmaceutical industry standards for plant construction, qualification, and conversion.
What qualification services do you provide?
We provide end-to-end qualification services including DQ, IQ, OQ, PQ support, FAT, SAT, risk analysis, qualification scheduling, and SOP formulation to ensure systems and processes meet all regulatory and operational requirements.
Do you provide risk management and quality assurance support?
Yes, we offer comprehensive risk management, system/software quality assurance, configuration management, and problem resolution processes to maintain compliance and operational reliability throughout the lifecycle.
Do you support customers after project completion?
Absolutely. Our support extends beyond project completion with services such as change control, documentation support, operator training, maintenance lifecycle assistance, and system retirement/disposition support.
Why choose your qualification and compliance services?
With years of experience in pharmaceutical plant construction, continuous industry training, and strong technical expertise, we deliver high-quality qualification, validation, and compliance solutions with complete documentation and regulatory confidence.
