Quality & Accreditation
Quality Built Into Every Step
At BioTrace Labs, quality is central to the way we are building our laboratory. From method selection and instrument qualification to documentation and result review, our focus is on establishing a disciplined, traceable, and scientifically sound approach to analytical testing.
Method Validation & Verification
We are developing appropriate procedures to establish that analytical methods are suitable for their intended use, with performance evaluation based on relevant method requirements.
Instrument Qualification & Performance
Our laboratory setup includes instrument installation and the necessary qualification, calibration, maintenance, and performance checks appropriate to each instrument and method.
Documented Quality Systems
We are establishing controlled procedures, technical records, and quality processes designed to support consistent laboratory operations and traceable results.
Scientific Integrity & Objectivity
We are committed to impartial testing practices, clear reporting, and appropriate communication of analytical findings and limitations.
Working Toward ISO/IEC 17025 Accreditation
BioTrace Labs' ISO/IEC 17025 accreditation process with Perry Johnson Laboratory Accreditation, Inc. (PJLA) is in progress. ISO/IEC 17025 provides an internationally recognized framework for the competence, impartiality, and consistent operation of testing and calibration laboratories. Our team is working toward establishing the systems and technical requirements needed for the accreditation process.
Accreditation status: Until accreditation is formally granted, BioTrace Labs will not represent itself as an accredited laboratory.
Supporting Applicable Regulatory Requirements
Our quality-system development takes into consideration relevant FDA dietary supplement requirements, including applicable provisions of 21 CFR Part 111, alongside appropriate laboratory practices and analytical method requirements.
Testing results can support a client's quality assurance program, but no individual test or laboratory report by itself guarantees overall product compliance.
