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QUALITY
Audit-ready by design.
Our laboratory operates with independent quality oversight, controlled procedures, complete analytical traceability and documented review workflows. SizeID.bio is operated by mibiC GmbH & Co. KG. Customer audits are welcomed.
Independent quality oversight
QA is independent from routine analytical execution. Technical review and independent quality review are documented before reporting.
ISO 9001:2015 quality management system
mibiC’s ISO 9001:2015 quality management system supports controlled documentation and defined responsibilities.
GMP procedures and analytical traceability
Laboratory work is performed under GMP-controlled procedures. Each analytical step remains traceable, linking particle images, measurements, classifications and reviewed results.
Validated data integrity
Analytical systems operate within a documented 21 CFR Part 11 framework, with validated software controls, traceable user actions and secure redundant internal and external data backup.
Documented system lifecycle
Lifecycle documentation runs from User Requirements Specification (URS) through Software Design Description (SDD). Part III SAT tests software and data-integrity functionality; external validation has been performed.
Controlled operation and system checks
SOP-supported weekly internal system checks and controlled review workflows support consistent operation from acquisition to report.
Customer audits welcomed
An external customer audit has been completed. We welcome further customer audits and discussion of the documentation relevant to your study.
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