QV-Compliance A/S has many years of experience with qualification and validation within the pharmaceutical industry and
other regulated industries according to the V-model. We can assist you with qualification and validation of:
- Bottle Pack equipment & Bulk process equipment
- Fermentors & bioreactors
- Purification equipment
- Isolators & VHP (Vaporized Hydrogen Peroxide)
- All types of SIP-installations (Steam In Place), SIP Equipment, Dry heat sterilization/ Depyrogenation tunnels, Autoclaves. See Thermal Validation.
- Temperature/humidity distribution, Pressure measurements.
- Qualification of loggers
- Filling equipment
- Packaging equipment
- Cycle Progression
We can help you with every step from risk assessment to PQ (FMEA, IAR, RRA, URS, IQ, OQ, PQ, V-model).
We can perform and coordinate qualification activities during a project such as writing validation master plans, validation plan and qualification protocols.
We can assist in every aspect of risk assessments according to your own quality management system.
With our years of experience in the qualification of production equipment,
from design/requirement specification to performance qualification or process validation
(URS, IQ, OQ, PQ and PV).
Furthermore, we can supplement your quality organization temporarily with manpower,
e.g during a project peek or during production.
Specialists in QV-Compliance A/S are trained in ISO 9000 based quality systems and are up to date with GxP requirements within the field of quality.