Clinical and Bioanalytical laboratory Audits

One of the critical tasks for a Good Laboratory Practices (GLP) nonclinical laboratory study or Clinical Trial team is choosing a bioanalytical laboratory vendor that will meet their study needs. A well-managed bioanalytical study with proper Sponsor oversight will go a long way to ensure the generation of accurate data and quality data. Many companies have a Research & Development Quality Unit that includes people with auditing skills in Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs). Many R&D auditors have a background in what is required to audit a bioanalytical laboratory for either Clinical trials, GLP, GLP-Like or best laboratory practices. Bioanalytical Laboratory Vendor Qualification Audits.

 

  • Sample Handling, Sample Chain of Custody
  • Method Validation
  • Method Validation
  • Computer System Management
  • GDP and GLP compliance
  • Operating procedures and protocol compliance
  • Clinical Affairs & Regulatory Strategies

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