Quality Assurance

Seventh Wave’s Quality Assurance Consulting Services operate as an extension of your internal quality procedures, conducting inspections or audits on your behalf to improve systems and overall compliance.  Whether you are a startup company with no internal quality assurance department, a large organization looking to outsource, or a laboratory desiring to become GLP compliant, Seventh Wave will work with your team to increase efficiency and ensure that all compliance responsibilities are met.

Services provided include:

  • Vendor Inspections
  • Facility Inspections
  • In-Process Inspections
  • Data and Report Audits
  • Part 11 Electronic Systems Audits
  • Quality Systems Audits
  • GLP Training
  • SOP Development and Preparation

Seventh Wave QA personnel have extensive industry experience in GLP regulated studies working with the US FDA, US EPA, OECD, JMHLW, JMAFF and 21 CFR Part 11.

Our areas of expertise include:

  • General Toxicology
  • Histopathology
  • Analytical Chemistry
  • Bioanalytical Analysis & Method Validation
  • TK/PK/PD Evaluation
  • Archives
  • Computer Systems Validation
  • Corrective and Preventative Actions (CAPA)
  • Quality Management Systems

Contact us to learn more.