Validation support is readily available to help you fulfil regulatory requirements when working in GxP environments. Gyros supports 21 CFR Part 11 compliance by offering signed IQ/OQ documentation. With its IQ/OQ documentation, Gyrolab xP meets the requirements for compliance with 21 CFR Part 11. Services include fully documented activities and test protocols required in order to meet requirements.
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Validated hardware and software, compliant with 21 CFR Part 11 regulations, and consumables |
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Gyros trained and qualified service personnel conduct IQ/OQ services in your working environment |
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IQ and OQ documentation and signed report will be provided following installation |
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Gyros personnel can provide guidance for the User Acceptance Test (PQ) |
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Service contract agreements, including Preventive Maintenance that maintains the instrument's validated state |
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User training with certification to ensure competent use of Gyrolab is carried out by Gyros trained and qualified personnel |