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Frequently asked questions
Q: Are your systems for production of biomedicines designed to operate in accordance with GMPs?
A: The design of and materials of construction in our production systems fulfill all relevant FDA regulations and our systems are used in numerous FDA approved processes. Documentation for submission to regulatory authorities supports our systems and to save time and cost during the validation process we provide IQ/OQs for each system.
UNICORN™ is validated software; it is developed, tested and documented in accordance with the System Development Life Cycle Concept. External auditors have audited and supported every major revision. The software comes with a Validation Support Package.
Q: Is UNICORN designed to operate in compliance with 21 CFR Part 11?
A: Yes, UNICORN has a design that complies with 21 CFR Part 11 and the software is audited at every major revision. We also provide a Part 11-IQOQ document to verify that our automated UNICORN based system fulfills the requirements of the FDA 21 CFR part 11 regulation at customer site.
Q: What is required to keep the system in a validated state after a UNICORN upgrade?
A: We sell Change Control Protocols that will qualify the installation of the new UNICORN version and verify that the system functions properly afterwards.
Q: Will your IQ/OQ cover all aspects of the system installations, for instance personnel training, utility checks and documentation?
A: Yes, our system IQ/OQ verifies related issues as well as installation and operation of the system. However, our personnel cannot perform these tests, which are the responsibility of the system owner.
Q: What is the delivery time of IQ/OQ protocols?
A: Generally, two weeks after equipment delivery and formal order received.
Q: Can I receive my IQ/OQ binder before the system delivery?
A: We can normally not deliver IQ/OQ documents before system delivery, as the system documentation is not finished until then.
Q: Is it possible to have the IQ/OQ documents customized?
A: We do some document modifications free of charge. These modifications can be in the category of additional tests, custom front page, custom approval page or other minor customizations that has been agreed on. Changes requiring more work will be charged for.
Q: Do you have IQ/OQ performance as a service and how long does the performance take?
A: Yes, we do offer IQ/OQ performance. It normally takes 5 days for Process systems and three days for ÄKTA™ systems.
Q: Do you perform network validation?
A: Network validations are not a prioritized product area for us. It is determined from case to case if we will do it. We do however qualify systems connected in network.
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