Qualifications
WE QUALIFY WITHOUT LIMITATION
ANY SYSTEMS AND PROCESS EQUIPMENT
We offer qualification not only for individual systems or equipment, but also in the form of a comprehensive coverage of qualification work for new projects.
In the initial stage we can prepare for you:
- User requirement specification (URS)
- Risk Analysis (RA)
- Impact Analysis (IA)
- Project Qualification (DQ)
- Validation Master Plan (VMP)
In the next stages we can offer participation in:
- Factory acceptance testing (FAT)
- Site acceptance testing (SAT)
The qualification itself is then carried out sequentially in all stages:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Process Qualification (PQ)
WE OFFER THE FOLLOWING QUALIFICATIONS
EQUIPMENT AND SYSTEMS
Clean media
PW – purified water
WFI – water for injection
PS – pure steam
CA – compressed air
CN – compressed nitrogen
CO – pressurized oxygen
Thermal processes
Sterilization – sterilizers, tunnels
Thermal sanitation
SIP system
Process equipment and systems
Storage tanks / reactors / product pipelines
Lines for solid dosage form
Lines for liquid dosage form
Temperature/humidity maps
Warehouses
Refrigerators/freezers
Incubators
Stability rooms
Computer control systems
Embedded control systems
WMS Qualification
MES Qualification
EBR Qualification
Other services
Validation supervision
Consultation
Preparation/check of validation documentation
get in touch
You have an individual requirement
or an idea and you don’t know how to proceed?
Always something extra in order to help you.
Impartial view and experience
from dozens of companies.
From idea to implementation.
We can help you.
get in touch
A few reasons why working with us is worth it:
- Always something extra in order to help you.
- An unbiased view and experience from dozens of companies.
- From idea to implementation. We can help you.
