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9237378BR MDx, InstallationThe Installation, BR MDx facilitates the quick implementation of the BioRobot MDx into the lab routine by minimizing the instrument start-up phase. It covers the hardware ａnd software installation of the BioRobot MDx instrument ａnd provides the user with an introductory training on operation ａnd user maintenance. The installation includes labor ａnd travel costs. The performance of the installation process is documented on a GMP/GLP-compliant Field Service document.CNY

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9243654Comprehen Valid., Other Quant. Sys."""The Comprehensive Validation Support plan specific to a laboratory＇s needs will incorporate all of the requirements for the internal validation guidelines from the FBI＇s Quality Assurance Standards (QAS).

The Comprehensive Validation Support service includes all travel ａnd labor charges for up to 20 days by the QIAGEN Validation Team. Typically, one week will be required to extract, quantify, ａnd amplify the validation study samples ａnd may require multiple individuals. Usually, two weeks is required to analyze the data ａnd one week to write the final report. The expected time period to complete the Comprehensive Validation is six weeks. The actual time may vary depending on resource availability, including laboratory time dedicated to validation activities.

Lab Work – The QIAGEN specialist(s) will travel to the laboratory to conduct the on-site validation lab work. The QIAGEN specialist team will perform ａnd complete all extractions, quantifications, amplfications, ａnd capillary electrophoresis. The laboratory is responsible for providing systems/protocols that may be needed (generally laboratory SOPs, ex. interpretation guidelines). Additionally, the laboratory staff may be required to provide additional data needed for interpretation (ex. quantification/amplification/CE results) during the data review phase of the validation. 

Once the final scope of the validation is determined, QIAGEN will provide a quote for all consumables required for the validation.  Non-QIAGEN chemistry ａnd accessories are not included ａnd should  be purchased to cover the validation experimental design including qPCR, STR, NIST standards, required samples types (blood, semen, buccal samples) ａnd required substrates (swabs, materials, etc).   For planning purposes ａnd to ensure a smooth process, the Customer is expected to have all materials on-hand ａnd inventoried one (1) week prior to the validation start date.

Data Analysis – The Comprehensive Validation Support plan encompasses data collection (quants, amps, CE) during the on-site visit. The laboratory may be responsible for sharing (typically electronically via e-mail) any validation data requested after the on-site visit. A QIAGEN specialist will complete all of the data analysis produced from the validation study design. This includes qPCR (quant) ａnd STR (amp) analysis ａnd linkage to starting samples.

Validation data CD/flashdrive – QIAGEN will review the validation data ａnd draft a validation summary document, ensuring compliance with the FBI＇s QAS requirements/standards. QIAGEN will send validation data in an electronic format (email/CD/flashdrive) to the laboratory. The laboratory is responsible for final compilation, any format change preferences, review ａnd signoff of the validation report. The documentation provided by QIAGEN will aide in demonstrating compliance with all accreditation guidelines during laboratory audits. Should a hard copy of the validation study be preferred, the laboratory is required to specify prior to the onset of the validation.

Post-validation QIAGEN-to-Laboratory Transfer – Following completion of the validation ａnd generation of the draft validation summary document, a designated member of the QIAGEN validation team will review the validation with the Lab Manager ａnd the Technical Leader. Following sign off on the validation report, training of the laboratory DNA staff will occur. Refer to the Post-validation Competency Training for additional information. """CNY

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