Quality Assurance

To assure a successful and accurate bioanalytical phase

Quality Assurance

Regulatory Compliance

Alturas Analytics, Inc. is compliant with the Food and Drug Administration (FDA), Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies, 21 CFR Part 58, as well as provisions of other regulations and guidelines that apply to bioanalysis and multi-site studies. 

  • Food and Drug Administration (FDA)’s Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies, 21 CFR Part 58
  • Food and Drug Administration (FDA) Electronic Records Electronic Signatures, 21 CFR Part 11

Our Quality Assurance Unit (QAU) is a stand-alone unit to provide assurance that non-clinical and clinical study activities are conducted in compliance with procedures and applicable regulations.  The QAU works with scientific staff and management to continually improve Standard Operating Procedures (SOPs) and quality systems.  The QAU has their own set of SOPs to independently assure that defined requirements for the processes have been followed and that inspections occur on a regular basis including:

  • Facility Inspections (including process audits)
  • In Process Inspections
  • Data Inspections
  • Report Inspections

Standard Operating Procedures (SOPS) and Document Management

The QAU develops and implements comprehensive, accurate, and easy to follow SOPs to describe the operations of Alturas Analytics, providing structure and ensuring consistency between individuals carrying out the various procedures.  The SOPs reflect full compliance with all applicable regulations. A controlled, current, and effective version of each SOP is available to each employee at all times. The SOPs are reviewed and revised according to updates or changes in regulations, technology, processes, and resources.

Training

The QAU staff are members of the Society of Quality Assurance and stay current with industry regulations, standards, and guidance documents by regularly attending national or regional meetings, workshops, and webinars sponsored by SQA and other organizations.

The entire staff at Alturas Analytics, Inc. is required to take part in various training activities as new employees and as part of an on-going professional development training program. Some specialized training areas include annual regulatory training, safety training, business continuity plan, and disaster recovery training. 

Training Resources:

 

Future Science Editorial Now in Print

"Microspray and Microflow Liquid Chromatography: The Way Forward for LC–MS Bioanalysis" Shane R Needham, Ph.D.


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