LABORATORY INFORMATICS

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Specialty Biopharmaceutical Company

Quality System Consulting Services

LabAnswer provides assistance to laboratories seeking accreditation to ISO/IEC 17025 including the various discipline-specific enhancements of ISO/IEC 17025, e.g.:

  • AOAC International Accreditation Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Foods, and Pharmaceuticals
  • The NELAC (National Environmental Laboratory Accreditation Conference) Institute (TNI) Management and Technical Requirements for Laboratories Performing Environmental Analysis
  • American Association of Veterinary Laboratory Diagnosticians (AAVLD) Essential Requirements for an Accredited Veterinary Medical Diagnostic Laboratory.
  • American Society of Crime Laboratory Director / Laboratory Accreditation Board (ASCLD/LAB) International Supplemental Requirements

LabAnswer's Services Include:

  • Training to the requirements of ISO/IEC 17025 and enhancements to include required terminology, documents and records.
  • Performing a gap analyses to determine compliance of a laboratory’s current policies and procedures with the requirements of the standards to which the laboratory wishes to become accredited.
  • Providing guidance on how to correct deficiencies.
  • Writing Quality Manual sections and Standard Operating Procedures (SOPs), as well as providing training on how to write compliant Quality Documents.
  • Performing pre-assessment audits to ensure that laboratory operations are in compliance with the Quality System as written.
  • Providing assistance/training/guidance on establishing measurement uncertainty for your methods.