Building and Sustaining Laboratory Compliance

Regulatory compliance in the laboratory centers on demonstrating control over instruments, processes, data, and documentation. In regulated environments, it is not enough for work to be performed correctly; laboratories must also be able to show, through appropriate records and defined procedures, that activities were carried out as intended and in accordance with applicable requirements. This expectation underpins many common compliance frameworks, including Good Laboratory Practice (GLP), ISO/IEC 17025, and 21 CFR Part 11.

This resource guide brings together articles that address how laboratories can meet these expectations. It begins with the role of instrument qualification and validation, explaining how installation, operational, and performance qualification are used to establish that equipment and supporting software function as intended. From there, the guide examines data integrity and documentation, focusing on how records are created, protected, and reviewed, as well as how software features and laboratory systems support traceability and accountability. The final chapter turns to how  compliance is evaluated and maintained over time. It covers internal quality audits, accreditation assessments, and GLPs, providing context for how laboratories are reviewed against defined standards and requirements. Taken together, the articles in this guide are intended to clarify what laboratories are expected to demonstrate, how compliance-related tools and systems support that effort, and how ongoing review helps sustain regulatory alignment.

This guide covers core compliance topics relevant to regulated laboratories, including instrument qualification and validation, data integrity and documentation practices, compliance-supporting software and laboratory systems, and preparing for audits and accreditation assessments. The content addresses how these requirements are defined, applied, and reviewed across common regulatory and accreditation frameworks.