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Services > Validation and Rentals > Qualification and Validation Services
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11/17/2018 Qualification and Validation Services - IQ, OQ, PQ
At Ellab, we understand that our client’s needs are unique, and those needs will vary based on the evolving industry
requirements for equipment qualification and process validation. Our expertise is specialized in life sciences, which includes
the pharmaceutical, medical device and biotechnology industries. Additionally, we o er testing and qualification services in the
biorepository/blood banking, cosmeceutical, nutraceutical, food, beverage and hospital industries.
Guidelines and Standards that Ellab Qualification and Validation Services Follow
Our validation services meet industry requirements and guidelines established by government agencies (FDA, EU/EMA/EMEA,
PMDA, TGA), industry organizations (WHO, ISO, ICH, ASTM, PDA, ISPE, CAP, USP), and industry guidelines (cGMP, cGLP, cGxP,
cGDP, GAMP 5, 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211). Our equipment and software systems are validated and 21
CFR Part 11 compliant. Our ValSuite software has been audited for data integrity by third party companies.
Final Reports
We understand how critical it is that all documentation meets current Good Documentation Practices (cGDP). For example,
summary reports for performance qualification (PQ) are generally submitted to the FDA during facility licensing. Our validation
experts know what is expected and how to accurately generate reports. We always provide both hard and soft copies of the
following:
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11/17/2018 Qualification and Validation Services - IQ, OQ, PQ
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11/17/2018 Qualification and Validation Services - IQ, OQ, PQ
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11/17/2018 Qualification and Validation Services - IQ, OQ, PQ
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