Validations
Successful validations requires proper planning and defined protocols.

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.
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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
Efficient
Effective
Reliable
Efficient
Effective
Reliable
Efficient
Trust
Responsibility
Results
Trust
Responsibility
Results

Our experience is our key asset and building trust is our goal!

30 yrs
Our team members have been serving the life science industry for more than 30 years.
100%
return and retention rate
We are proud that we are able to build and trust with our clients and retain of clients for multiple years.

Recent articles

See all articles

The FDA LDT Final Rule and SCOTUS ruling on the Chevron Doctrine - What is next?

The FDA's LDT Rule Explained

info@altaq.com
301-304-4888
Maryland, Bethesda; California, San Diego
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