Qas

QAS provides these services: QAU development/maintenance Master & inspection schedules/study copies Study inspection/management reports for method, SOPs & raw data Protocol & SOP deviation authorization/documentation Final study data report statement Records, auditing metrics, checklists/forms Inspection guidance (see below) Data/Report Auditing in US & internationally regulated non-clinical study data/reports for Toxicology (Reproductive, Teratology, Neurotoxicology, Immunology & Acute, etc.), Toxicokinetics/ Pharmcokinetics, Histopathology, Genetic Toxicology & Analytical Chemistry. US EPA Regulated Safety Study Data and/or Report Auditing for Analytical Chemistry Product Chemistry, Residue Chemistry, Health Effects and Ecological/Environmental Effects. US FDA CVM Good Clinical Practice Guideline expertise. Facility/Records Review QA Records, Personnel Training Files, Method Validations & SOPs Equipment Records/Archives & Computerized Systems Validation Installation, Operating & Performance Qualifications Facility wide monitoring/review including its QA Inspections Regulatory inspections facilitation Facilitate FDA’s unannounced, directed and/or for-cause inspections Gap Analysis & Compliance Assessments Third Party Inspections for current and/or future study placement Targeted Subcontractor/Vendor inspections utilized by sponsor or CRO Training On-site training on US & International Good Laboratory Practices Specialized training including but not limited to new/refresher employee orientation, regulatory and/or third party inspection prep, FDA CVM EPA OCSPP ICH & OECD guidelines, QA auditing/auditor training, Quality Control & Pesticide Product Labeling SOP/Document Control SOP generation or supplementation of current SOP/document control practices Procedures & develop Personnel, Equipment, Quality Assurance & Animal Care/Handling SOPs Forms, form directories & mechanisms for document control