To get your systems up and running quickly while ensuring that all regulatory requirements are met, our experienced engineers will partner with you to make certain that your equipment is qualified and fully operational for your specific process. Our qualification services include:
- Installation Qualification and Operational Qualification (IQ/QQ): Once your system has been site accepted, we will ensure that it is fully operational to your exact specifications, and that operation is documented and compliant with all pharmaceutical regulatory requirements.
- Performance Qualification (PQ): A trained biomanufacturing engineer will prepare your equipment and support both an engineering run and an actual run of your process recipe, providing the confidence you need to fully qualify and implement your new system.
When you’re under pressure to get underway as quickly as possible, we can ensure that your systems function as intended for your specific process. To learn more, contact us today.