GLP Compliance

Alturas Analytics, Inc. complies with GLP and Part 11 requirements

GLP Compliance

Regulatory Compliance

All work performed at 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. 

Compliance

  • 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

 

Standard Operating Procedures (SOPs)

Written SOPs have been developed to describe the operations of Alturas Analytics, Inc. and are necessary to provide structure and ensure consistency between individuals carrying out the various procedures.  A controlled, current and effective version of each SOP is available to each employee at all times.  The SOPs are periodically reviewed and revised according to updates or changes in regulations, technology, processes and resources.