When is validation of a laboratory-developed procedure required?

Validation of a laboratory-developed procedure is required when the work must be done by an accredited lab. Accreditation signifies that a laboratory has demonstrated its competence to carry out specific tests or calibrations according to established standards. As part of this accreditation process, procedures must be validated to ensure they consistently produce reliable, accurate results. This validation process is crucial for maintaining credibility and compliance with regulatory requirements and industry standards.

In contrast, while high-precision instruments, new procedures, and publications of results may necessitate certain levels of verification and quality control, they do not inherently require validation in the same way as mandated by accreditation standards. Accreditation carries with it specific obligations for proving the effectiveness of laboratory methodologies through validation. Hence, the pathway to maintaining accreditation and trustworthiness as a lab often hinges on the proper validation of all developed procedures.