11/17/2018 Qualification and Validation Services - IQ, OQ, PQ

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the USA, Canada, Europe and the Philippines. We o er a wide variety of validation services to meet
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Equipment Qualification & Validation Services

Ellab not only manufactures some of the best temperature mapping equipment available; we also o er validation services
specializing in temperature mapping. Our team of in-house expertly trained, validation engineers provide on-site validation and
qualification services globally, with the best customer service in the industry. Our engineers are experts in temperature
mapping and are available as a package with pre-calibrated Ellab equipment, ready to hit the ground running. We can help you
meet complex requirements in regulated environments with significantly reduced test equipment risk.

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.

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Our team of expert validation engineers have a focus on the quality and accuracy of all documentation provided to you for your
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project. Clients have the option to provide us with report, protocol and SOP templates or have Ellab draft documentation
designed specifically for the project.
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Qualification Protocol Test Case Examples
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11/17/2018 Qualification and Validation Services - IQ, OQ, PQ

 Power O tests V-LIMS CAREERS LANGUAGE

 Door Open tests
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 Temperature Distribution tests
 Temperature Penetration tests
 Alarm testing
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 Loaded and Empty Mappings
 Power Failure tests
 Instrument/equipment calibration
 And several more…

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:

 Final summary report

 Temperature mapping data
 Test equipment calibration certificates (DANAK accredited calibration upon request)
 Pre/Post sensor calibration data
 Employee training records
 Audit trails generated by our ValSuite validation and calibration software
 IQ/OQ/PQ/CQ/RQ Protocols
 Standard Operating Procedures (SOPs)

 
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Trollesmindealle 25
3400 Hillerød
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