Control access
Organize users and permissions around the responsibilities of your team.
Security overviewTrust the process.
Inspect the evidence.
A lab’s quality system needs more than a promise. Explore the controls and documentation available to support your assessment.
Follow the history
Keep changes and approvals in an append-only audit trail.
Read published controlsKeep signatures human
Use authorized reviewers for verification, approval, and release.
Review capability mappingDocumentation you can examine
Start with the details.
21 CFR Part 11 capability matrix
Inspect the published mapping between requirements and product controls.
Read the matrixISO/IEC 17025 alignment guide
Review the clause-by-clause mapping to help assess fit for your lab.
Read the guideA sample Certificate of Analysis
See the type of report your client can receive before you begin.
View sample COASecurity overview
Review access controls, the audit trail, and the published security details.
Read security detailsCapability mappings describe product controls; they are not certifications. Each lab is responsible for validating its use of the system and meeting the requirements that apply to its work.
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