FDA's core regulations governing drugs, devices, biologics, and electronic records — the backbone of US life-sciences compliance.

Parts covered

International standards for quality management, medical devices, laboratory competence, and information security.

Standards covered

Good Practice quality guidelines spanning manufacturing, laboratory, clinical, distribution, and pharmacovigilance domains.

Practices covered

Standards governing transfusion medicine, cellular therapies, and biotherapies — including donor management and patient blood management.

Programs covered

College of American Pathologists laboratory accreditation — the gold standard for clinical and anatomic pathology programs.

Checklists covered

Clinical Laboratory Improvement Amendments — federal regulatory standards governing all clinical laboratory testing in the United States.

Complexity levels

AICPA Trust Services Criteria for security, availability, processing integrity, confidentiality, and privacy of customer data.

Trust criteria

Health Insurance Portability and Accountability Act — privacy, security, and breach notification rules for protected health information.

Rules covered

European GMP requirements for computerized systems used in regulated activities — the EU counterpart to 21 CFR Part 11.

Adjacent standards

Data integrity principles enforced by every kind of audit log Kintavo writes — the operating contract for trustworthy regulated data.

Principles

International Council for Harmonisation guidelines — the global baseline for pharmaceutical quality, safety, and efficacy.

Quality guidelines

Specialty accreditation programs for tissue banks, transplant centers, and cellular therapy programs across North America and Europe.

Programs covered