Compliance by design, not by checklist
LIMS BOX embeds ISO 17025 and 21 CFR Part 11 requirements into every workflow. Your lab doesn't prepare for audits — the system keeps records survey-ready.
ISO 17025 Readiness
The international standard for testing and calibration laboratories. Required for accreditation by A2LA, ANAB, TNI/NELAC, and state certification programs.
Complete Sample Traceability
Every result links to the analyst, instrument, calibration status, QC batch, and chain of custody record. Assessors can trace any result back to its origin in seconds.
Analyst Competency Tracking
Training records, method qualifications, and competency demonstrations are tracked per analyst. The system prevents unqualified analysts from reporting results on methods they haven't been trained on.
QC Enforcement
Method blanks, LCS, LCS duplicates, matrix spikes, and duplicate analyses are enforced at the batch level. Out-of-spec QC results block reporting until the failure is investigated and documented.
Document Control
SOPs, method references, and work instructions are version-controlled within the system. Analysts always work from the current approved version.
Equipment Management
Instrument qualification (IQ/OQ/PQ), calibration schedules, and maintenance logs. Automated alerts when calibration is due or when an instrument is out of service.
21 CFR Part 11 Compatibility
FDA regulations for electronic records and electronic signatures. Required for pharmaceutical QC, clinical, and drug testing laboratories.
Immutable Audit Trails
Every action — data entry, edits, approvals, deletions — is logged with user ID, timestamp, original value, new value, and reason for change. Audit logs cannot be edited or deleted retroactively.
Electronic Signatures
Digital signatures satisfy 21 CFR Part 11 requirements for electronic records. Password-authenticated, legally binding, and permanently tied to the signed data.
Access Controls
Role-based permissions ensure analysts, reviewers, and administrators can only access functions appropriate to their role. Failed login attempts are logged and can trigger account lockout.
Data Integrity (ALCOA+)
All records are Attributable, Legible, Contemporaneous, Original, and Accurate. The system enforces ALCOA+ principles by design — not as an afterthought.
System Validation Support
LIMS BOX provides validation documentation templates, including IQ/OQ/PQ protocols, test scripts, and traceability matrices to support your validation effort.
What “compliance-ready” actually means
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