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1-10 employees
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Pharmaceuticals
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1720 S 13th Street, Beatrice, Nebraska 68310, US
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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
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Quality Assurance Services (QAS) Email Formats | Example Email Formats | Percentage |
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{f}{last} | [email protected] |
75.00%
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The widely used Quality Assurance Services (QAS) email format is {f}{last} (e.g. [email protected]) with 75.00% adoption across the company.
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