Supplier Quality Audits

Our team of ASQ certified quality auditors will provide a turnkey service of planning and executing suppliers audits, follow up and close out for your organization. This service is for Contract Manufacturer Organizations, Contract Research Organizations and Contract Laboratories.

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Internal Quality Assessments

Our team of Quality professionals can complete a external review of your Quality Systems, SOPs and Processes and create solutions and mitigation strategies. We will also assist your organization in execution. We can be an independent 3rd party review of your key  failure investigations and train your internal investigation team.

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Training

QSI can provide comprehensive training for your organization in Failure Investigation, Risk Management, Design of Experiments DOEs and responses to FDA inquiries and deficiencies.

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FDA Response Assistance

FDA deficiencies 

FDA 483 Observations

FDA Warning Letter Observations

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Human Factor Studies

Our team can assist your organization with interfacing with Human Factor Study Contractor, reviewing experimental design, protocol and being on site during execution.