Framework for the quality assurance of 'omics technologies considering GLP requirements.

ABSTRACT: 'Omics technologies are gaining importance to support regulatory toxicity studies. Prerequisites for performing 'omics studies considering GLP principles were discussed at the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Workshop Applying 'omics technologies in Chemical Risk Assessment. A GLP environment comprises a standard operating procedure system, proper pre-planning and documentation, and inspections of independent quality assurance staff. To prevent uncontrolled data changes, the raw data obtained in the respective 'omics data recording systems have to be specifically defined. Further requirements include transparent and reproducible data processing steps, and safe data storage and archiving procedures. The software for data recording and processing should

SUBMITTER: Kauffmann HM 

PROVIDER: S-EPMC6816020 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature