Audit and Inspection Services
We Provide Everything You Need!
Systems and Documents
Expertise in the conduct of internal system (Process) and document (Data) audits to include:
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Design/Device History File
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Validation
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Batch Records
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Investigator Brochure
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Protocol
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ICF
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Computer Systems
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Clinical Study Reports
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Pharmacovigilance
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PSMF
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TMF
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Investigator Initiated Studies
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Functional Areas
Inspection Preparation and Process Support
With a breadth of international inspection experience, we can help your organization with mock inspections and/or streamlining the inspection process to ensure your inspections are managed with the best processes and systems of communication.
Inspection Training
We can provide training focused on how to anticipate the inspection requests and what documentation to have ready from the start of the inspection. By completing this training, we have seen inspectors spend less time at the facility as your preparedness shows an understanding of the requirements. We offer training of:
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Sponsor Staff
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Vendor Teams
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Investigator Sites