Creation of documentation with a professionally trained validation team, utilizing certified equipment, following current methods and protocols.
Regular maintenance, servicing and validation of equipment, systems or facilities ensures safety during use and extends the life of the device. Modern system management requires continuous care in maintenance and traceability of documentation through all phases of the system’s life cycle. The documentation is continuously updated, from the design phase, construction, commissioning and system qualification and subsequent validation to confirm satisfactory parameters. The above requires systematic action and knowledge of standards and test methods that are applied in the pharmaceutical and healthcare environment.
Preparation of qualification and validation documentation
We create documentation using advanced programs that ensure good documentation practice (GDP – Good Documentation Practice) – COMOS, DMS, KNEAT.
- URS – User Requirement Specification
- GMP RA – Risk Assessment
- RDS – Room Data Sheet / Roombook
- FS – Functional Specification
- TS – Technical Specification
- DQ – Design Specification
- MC – Mechanical Completion procedure
- COMMISSIONING – FAT / HOURS
- IQ – Installation Qualification
- OQ – Operation Qualification
- PQ – Performance Qualification
- TEMPERATURE MAPPING – Cold or Hot Rooms, Chambers, Warehouses
- Sensor calibration certificates
Services
We create validation, qualification and requalification documentation related to HVAC, technological media, clean rooms, temperature-controlled equipment and other equipment of the same or similar domain, such as transit chambers, LF cabins and cabinets, BSC cabinets, isolators, cooling chambers, refrigerators and spaces as warehouses, thermostatic rooms, etc.
- Commissioning of the HVAC system
- Balancing the HVAC system
- Qualification of cleanroom and devices
- Testing the integrity of the HEPA filter
- Space classification – Particle counting
- Space recovery test
- Lighting test
- Sound test
- Visualization of air flow
- Temperature and relative humidity mapping
- Balancing the technological media distribution
- Calibration of differential pressure, temperature and relative humidity gauges
Professional qualification of the validation team
Our CQV systems qualification team is professionally trained and keeps up with trends, new methods and protocols. With extensive experience in qualifying and validating systems of well-known pharmaceutical manufacturers and equipment adapted to user needs, we help users in planning and developing the qualification and validation phases, advise on the legal framework and provide a complete documentation package. We perform complex tests in accordance with GMP (Good Manufacturing Practice) guidelines within the given deadlines for quick commissioning. Our team is certified according to the CTCB-I standard.
Certified equipment
We have new equipment from renowned manufacturers aligned with changes in market standards. The equipment is regularly calibrated according to requirements, at least every 12 months. We adapt the tests according to the requirements of the investors and the selection of the method according to the preferences of the market.
