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VALIDATIONS
AltaQ offers a range of validation services from planning through execution and final reporting. This covers product, process, system, software, equipment, facility and more.
We can work with you to develop and execute validation protocols including IQ/OQ/PQ activities.
Software Validation
Including software verification, test planning, IQ/OQ/PQ
Clinical Validation
Developing and executing clinical studies for IVD/LDT and medical devices
Facility Qualification
Facility qualification as a part of PMA/PAI inspection
Equipment Qualification
Installation, Operational, and Performance Qualifications (IQ, OQ, PQ)
Process Validation
Manufacturing process, packaging, labeling, cleaning, etc.
Analytical Validation
Developing and executing analytical studies for IVD and LDT products
ERP and MRP
Enterprise Resource Planning and Manufacturing Resource Planning System Validations
eQMS Validation
Development and execution of eQMS to meet 21 CFR Part 11 requirements
30 years
Our team members have been serving the life science industry for more than 30 years.
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30 years
Our team members have been serving the life science industry for more than 30 years.
