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Industry-Specific

Global Standards

FDA 21 CFR Part 11

Electronic records, electronic signatures, and data integrity across FDA-regulated laboratory systems.

OECD Good Laboratory Practice (GLP)

Quality systems for non-clinical laboratory studies supporting regulatory safety and efficacy evaluations.

Good Manufacturing Practice (GMP)

Quality systems governing manufacturing, laboratory operations, and product consistency across regulated industries.

Current Good Manufacturing Practice (cGMP)

Current quality practices supporting pharmaceutical manufacturing, laboratory testing, and process control.

Good Clinical Practice (GCP)

Clinical trial conduct, laboratory documentation, and data supporting regulated clinical investigations.

ICH E6 (GCP)

Clinical trial conduct, laboratory documentation, and data supporting regulated clinical investigations.

Good Pharmacovigilance Practice (GVP)

Safety monitoring, adverse event reporting, and lifecycle surveillance for medicinal products.

IEC 62304

Software lifecycle processes supporting development and maintenance of medical device software.

IEC 62366

Usability engineering supporting safe and effective medical device development.

IEC 60601

Safety and essential performance standards for medical electrical equipment used in laboratory environments.

Hazard Analysis and Critical Control Points (HACCP)

Hazard analysis and preventive controls supporting food safety throughout production and laboratory testing.

BRCGS Global Food Safety Standard

Food safety, quality management, and operational controls across manufacturing and laboratory environments.

Safe Quality Food (SQF)

Food safety and quality certification supported by documented laboratory testing and verification programs.

FDA Grade "A" Pasteurized Milk Ordinance (PMO)

Milk quality, laboratory testing, sanitation, and regulatory compliance for dairy products.

Good Agricultural Practices (GAP)

Agricultural production practices supporting product quality, traceability, and laboratory verification.

GLOBALG.A.P.

International agricultural certification supporting food safety, traceability, sustainability, and laboratory verification.

Globally Harmonized System (GHS)

Standardized classification and communication of chemical hazards across laboratory and industrial environments.

API Standards

Testing, inspection, and quality requirements supporting petroleum and petrochemical laboratory operations.

ISO 14001

Environmental management systems supporting sustainable laboratory and operational practices.

Good Documentation Practice (GDP)

Controlled documentation ensuring complete, accurate, traceable, and consistent laboratory and quality records.

Good Distribution Practice (GDP)

Storage, handling, distribution, and traceability of regulated products throughout the supply chain.

ALCOA+

Data integrity principles supporting complete, accurate, attributable, legible, and traceable laboratory records.

GAMP 5

Risk-based validation framework for computerized systems used in regulated laboratory environments.

Computer Software Assurance (CSA)

Risk-based software assurance focused on intended use and critical laboratory functions.

Computer System Validation (CSV)

Documented validation demonstrating consistent performance of computerized laboratory systems.

ISO 9001

Quality management systems supporting consistent laboratory processes and organizational performance.

ISO 13485

Quality management systems for medical device development, manufacturing, and laboratory operations.

ISO 14971

Risk management throughout the lifecycle of medical devices and associated laboratory activities.

ISO 15189

Quality management and technical competence for medical laboratory testing and diagnostic services.

ISO/IEC 17025

Technical competence, quality systems, and reliable results for testing and calibration laboratories.

ISO 17020

Competence of inspection bodies performing technical inspections and conformity assessment activities.

ISO 17034

Production and characterization of certified reference materials supporting laboratory accuracy and consistency.

ISO 17043

Proficiency testing programs evaluating laboratory competence through interlaboratory performance comparisons.

ISO 20387

Quality systems governing biological sample handling, storage, traceability, and biobank operations.

ISO 22000

Food safety management integrating laboratory testing, quality assurance, and supply chain controls.

FSSC 22000

GFSI-recognized food safety certification integrating laboratory verification, manufacturing controls, and supplier assurance.

ISO 22301

Business continuity supporting uninterrupted laboratory operations and critical scientific processes.

ISO 31000

Enterprise risk management supporting laboratory operations, quality systems, and organizational governance.

ISO/IEC 27001

Information security management protecting laboratory systems, scientific data, and regulated digital records.

ISO/IEC 27017

Cloud security controls protecting laboratory applications and scientific workloads hosted in cloud environments.

ISO/IEC 27018

Protection of personal information processed within cloud-based laboratory information systems.

ISO/IEC 27701

Privacy information management supporting responsible processing of laboratory and research personal data.

ISO/IEC 20000

IT service management supporting laboratory software, infrastructure, and regulated digital services.

FAIR Principles

Scientific data practices promoting findability, accessibility, interoperability, and long-term data reuse.

ASTM International

Consensus laboratory standards supporting standardized testing methods, measurements, and material evaluation.

AOAC INTERNATIONAL

Validated analytical methods supporting food, agriculture, environmental, and pharmaceutical laboratory testing.

Codex Alimentarius

International food standards supporting laboratory analysis, food safety, and regulatory harmonization.

WHO Good Manufacturing Practice (WHO GMP)

Pharmaceutical manufacturing, quality control, and laboratory operations aligned with WHO guidelines.

PIC/S GMP

Harmonized Good Manufacturing Practice supporting pharmaceutical manufacturing and quality laboratories worldwide.

ISBER Best Practices

Biobank operations covering biospecimen collection, storage, traceability, and lifecycle management.

CLSI Standards

Consensus standards supporting quality, consistency, and best practices in clinical laboratory testing.

ICH Q1

Stability studies supporting pharmaceutical product development and lifecycle management.

ICH Q2(R2)

Analytical method validation ensuring complete, accurate, and reproducible laboratory testing.

ICH Q3

Impurity testing and control throughout pharmaceutical development and manufacturing.

ICH Q5

Quality evaluation of biotechnology-derived pharmaceutical products throughout development and manufacturing.

ICH Q7

Manufacturing and quality management of active pharmaceutical ingredients across regulated production facilities.

ICH Q8

Quality by Design supporting systematic pharmaceutical development and process understanding.

ICH Q9

Risk management across laboratory operations, manufacturing, and pharmaceutical quality systems.

ICH Q10

Pharmaceutical quality systems supporting continual improvement throughout the product lifecycle.

ICH M11

Standardized clinical study protocols supporting laboratory documentation and regulatory submissions.

FDA 21 CFR Part 1271

Requirements governing donor eligibility, tissue handling, processing, storage, traceability, and recordkeeping.

Good Tissue Practice (GTP)

Quality practices governing the handling, processing, storage, distribution, and traceability of human tissues.

FACT Standards

Quality standards for cellular therapy collection, processing, storage, and administration.

JACIE Standards

Accreditation standards supporting hematopoietic stem cell transplantation and cellular therapy programs.

EU GMP Annex 1

Sterile manufacturing requirements supporting aseptic production of cell and gene therapies.