Systems & Compliance
Built for defensible, inspection-ready data.
Our quality framework aligns with ISO 17025 principles. We provide the technical validity and traceable reporting required for complex regulatory submissions.
Data Integrity Focus
100% peer-review on all analytical datasets.Organization
Defined responsibilities and escalation pathways that ensure management commitment to quality.
View GuardrailsPersonnel
Role-based training and continuous qualification programs for every analyst in the lab.
View GuardrailsEquipment
Systematic controls for the qualification, calibration, and preventive maintenance of lab hardware.
View GuardrailsDocuments & Records
Version-controlled systems that ensure data is attributable, legible, and readily retrievable.
View GuardrailsOperational Guardrails
Quality System Elements (QSE)
Governance & Accountability
Defined responsibilities and escalation pathways that ensure management commitment to quality.
Accountability
Designated Quality Manager with direct reporting lines to executive leadership, independent of production.
Audit Readiness
Internal audit schedules and management review cycles to identify and remediate system variances proactively.
Ethics & Impartiality
Strict policies governing the prevention of commercial or financial pressures on analytical results.
Technical Competency
Role-based training and continuous qualification programs for every analyst in the lab.
Training Records
Centralized matrix tracking initial training, annual re-qualification, and method-specific competency.
Technical Oversight
Peer-review system for 100% of raw data and final reports to ensure interpretation accuracy.
Safety & Compliance
Standardized onboarding covering GLP/GMP principles and facility-specific safety protocols.
Lifecycle Management
Systematic controls for the qualification, calibration, and preventive maintenance of lab hardware.
IQ/OQ/PQ
Formal installation, operational, and performance qualification for all high-complexity instrumentation.
Traceability
External calibration of critical measurement tools (balances, pipettes, timers) traceable to NIST standards.
Maintenance
Automated scheduling for preventive maintenance to minimize downtime and prevent analytical drift.
Knowledge Management
Version-controlled systems that ensure data is attributable, legible, and readily retrievable.
Document Control
Standardized SOP workflows with formal change control, versioning, and archivist oversight.
Data Integrity
ALCOA+ principles applied to all electronic and paper records to ensure permanent and accurate data.
Retention
Managed archival system for samples and records following defined regulatory retention schedules.
Need to verify our credentials?
We provide full ISO 17025 scopes of accreditation, SOP overviews, and sample submission guidelines for your QA team.