Specialized Data and Report Auditing
Quality Assurance Services has the capability and flexibility to perform data and/or report reviews either in our office or your facility. Having experience in either venue, we’re willing to work with you to best meet your needs. Our specialized data and/or report auditing capabilities include expertise in:
US and Internationally Regulated Non-Clinical Study Data and/or Reports; including but not limited to:
- Toxicology (Reproductive, Teratology, Neurotoxicology, Acutes, etc.)
- Pharmacokinetics/Toxicokinetics
- Histopathology
- Genetic Toxicology
- Analytical Chemistry
US EPA Regulated Safety Study Data and/or Report Auditing; including but not limited to:
- Product Chemistry
- Residue Chemistry
- Health Effects
- Ecological/Environmental Effects
US FDA CVM Good Clinical Practice Guidelines
Facility Records Review
- Quality Assurance Records Training Files
- Method Validations
- Standard Operating Procedures
- Equipment Records
- Archive Files
- Equipment and Computerized Systems Validation
- Installation, Operation and Performance Qualifications
The review of QAU records is frequently at the bottom of any facility’s priority list. Because it is assumed that since the QAU is in the position to monitor compliance throughout the facility, their internal records should be error-free and up-to-date. Often this is not the case. Let us QA your QA!
If you have the need for specialized auditing not listed in the choices above, please don’t hesitate to contact us. Let’s talk about what we can do for you.