QV-Compliance A/S has many years of experience with qualification and validation within the pharmaceutical industry and
other regulated industries according to the risk-based approach and the traditional V-model. We can assist you with qualification and validation of:
- Fermentors & bioreactors
- Equipment for chemical synthesis
- Purification equipment
- Temperature/humidity distribution, Pressure measurements.
- Qualification of utility
- Filling lines
- Bottle Pack equipment & Bulk process equipment
- Packaging lines
- Cycle Progression
- Isolators & VHP (Vaporized Hydrogen Peroxide)
- All types of SIP-installations (Sterilisation In Place), SIP Equipment, Dry heat sterilization/ Depyrogenation tunnels, Autoclaves. See Thermal Validation.
We can help you with every step from risk assessment to process validation (FMEA, IAR, RRA, URS, IQ, OQ, PQ, PV).
With our years of experience we can perform qualification of production equipment 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.
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 9001 based quality systems and are up to date with cGxP requirements within the field of quality.