Table 3 ReOmicS quality management system
From: Management at the service of research: ReOmicS, a quality management system for omics sciences
QMS topics | SOP | Contents | Ref |
|---|---|---|---|
Organizational aspects | Management of personnel | The organizational structure was designed according to a matrix scheme. Roles and responsibilities are compliant to GLP requirements | Fig 3 |
Study management | Study management | The management of the study is designed in compliance with GLP requirements. For each process step, a specific scientific SOP describes the procedure and refers to scientific protocols | Fig 5 |
Definition of raw data | Management of computerized systems | • Raw data are represented by:.txt or.xls files and image data (jpg, tiff and pdf) for the quality and quantity check steps, after the nucleic acid extractions;.txt or.xls files and image data (jpg, tiff and pdf) for quality and quantity check during and after libraries preparation;.txt or xls files and image data (jpg, tiff, and pdf) for the Illumina sequencing, and are produced before, during and after the run • sequencing data in fastq format and.bcl file produced by the platforms at the end of the sequencing | |
Data processing and storage | Management of computerized systems | Data are processed on CNR-IBIOM servers. Databases, pipelines, software programs, personalized scripts, bioinformatics and statistical tools are developed and stored on CNR-IBIOM servers and are adopted according to the planned project purpose and subject area (Genomic, Transcriptomics and Metagenomics) | Fig 5 |
Reporting | Study management | As per GLPs, The director of the study is charged with drafting and signing off the final report. The Final Report is reviewed by the QA and signed off only if compliant to GLP requirements | |
SW validation | Management of computerized systems | • The commercial equipment generating raw data is validated before starting production (“black box validation” or “performance-based validation”). This task is performed during the installation check by the technicians of the production company, and verified by the Laboratory Manager • Formulas in these spreadsheets are checked using alternative calculation methods and subsequently protected from accidental change. • External databases, whose reliability is guaranteed by internationally recognized scientific publications, are used to obtain reference sequences for integrating the internal reference set | |
Archiving | Archive management | The role of archivist is compliant to GLP requirements | |
Quality assurance | Quality assurance | The Quality Assurance Manager checks the study plan, study records, compiles the final Quality Assurance Statement for each study and annually plans and undertakes three types of audit: study-based, process-based and facility inspection | |
Equipment and facilities | Management of equipment and facilities | Equipment is managed from selection, purchase and identification through to maintenance and fault rectification, and elimination Facilities are organized and monitored by means of specific practices and records, according to GLP requirements | |
Samples | Acceptance, identification and characterization of samples | Samples are identified, managed, and stored according to GLP requirements | |
Materials | Management and disposal of materials | Chemicals, reagents, and solutions are identified, tracked, stored and disposed according to GLP requirements |
