Laboratory Compliance & Quality
The regulatory and quality frameworks governing laboratory work: GxP, data integrity and validation, accreditation and calibration, biosafety, chemical safety, waste and shipping, and facility requirements.
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Laboratory compliance is frequently encountered as a series of disconnected obligations — an accreditation audit here, a chemical hygiene plan there, a shipping rule discovered only when a sample is rejected. In practice these frameworks overlap heavily and share a common logic: define what you will do, do it consistently, record it contemporaneously, and be able to demonstrate all three to an auditor.
This section covers those frameworks as a connected system, written for researchers, lab managers and quality staff who need to act on them rather than merely cite them.
How this section is organised
- GxP and quality management systems — Good Laboratory Practice, Good Clinical Practice and Good Manufacturing Practice, and the SOP, deviation, CAPA and change-control machinery around them.
- Data integrity and validation — 21 CFR Part 11, computer system validation, audit trails, and the ALCOA+ principles.
- Accreditation and calibration — ISO/IEC 17025, CLIA and CAP, proficiency testing, and NIST-traceable calibration.
- Biosafety and containment — biosafety levels 1 to 4, institutional biosafety committee review, select agents, and biosafety cabinet classes.
- Chemical safety and hazard communication — GHS labelling, safety data sheets, the OSHA Laboratory Standard, chemical hygiene plans and inventory control.
- Waste, shipping and transport — waste stream segregation, dry ice shipping, and IATA dangerous goods requirements.
- Facility and environmental controls — cleanroom classification, ventilation and fume hood face velocity, eyewash and safety shower requirements.
- Device and diagnostics quality — ISO 13485, design controls, IVDR, pharmacovigilance and regulatory affairs practice.
- Compliance fundamentals — how these frameworks relate to one another.
Which framework applies to you
The frameworks are not alternatives; they stack according to what the work is and what it supports. Academic bench research is typically governed by institutional biosafety and chemical hygiene requirements. Work supporting a regulatory submission adds the relevant GxP framework and, where electronic systems hold that data, 21 CFR Part 11. A laboratory selling testing services adds accreditation under ISO 17025 or, for human specimens in the United States, CLIA. Determining the applicable stack before designing a quality system is considerably cheaper than retrofitting one after an audit finding.
Related sections
For the instruments and consumables these requirements apply to, see Laboratory Equipment & Instrumentation. For clinical trial conduct specifically, see Clinical Research Administration. For day-to-day bench operations, see Laboratory Operations.
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