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Service agreements—IQ/OQ

Services that keep you in peak condition

Installation
Our BioProcess service engineers assemble and install your system, perform installation tests and make sure they are ready for use.

Validation
Installation Qualification and Operation Qualification (IQ/OQ)

We can help certify your system and its operation with our IQ/OQ services. Our documentation packages and qualification services cover cGMP requirements and can include 21 CFR part 11 verification (optional). Our engineers are highly trained and able to complete IQ/OQ protocols quickly, efficiently and precisely. Initial certification and annual cGMP training mean our engineers are up to speed on the latest cGMP regulations and guidelines.

Change control protocols (CCPs)
We can also certify upgrades to your system or UNICORN™ software in a controlled manner. Our engineers ensure that the changes are carefully evaluated, verified, documented and reviewed.

Please review our service area for more information.

Imagined - Custom designed bioprocessing solutions to your production requirements.

Delivered - Specification, design & manufacturing to installed, validated & tested systems.

Supported - Support services offered to clients with customized BioProcess solutions.