LabPi Features

Lab Quality Management with 21 CFR Part 11 Support

Compliance controls, quality workflows, and semantic scientific search that support audits and help your team find critical data.

21 CFR Part 11 LIMSlab quality management softwarescientific data search

Quality, Compliance & Smart Search

Audit trails, electronic signatures, QC, and search that support an accreditation or Part 11 assessment.

Result Validation & Verification

Apply multi-level review rules, reference range checks, and delta limits before results are released to clients.

  • Configurable validation rules per analyte
  • Technologist and supervisor review queues
  • Auto-hold on out-of-range or critical values

QC Batching & Controls

Manage QC lots, Westgard rules, and control charts with automatic batch-level QC evaluation before release.

  • Levey-Jennings and Westgard rule engine
  • QC lot expiry and inventory tracking
  • Automatic run rejection on QC failure

Deviation & CAPA Logging

Capture non-conformances, root cause analyses, and corrective actions in a structured, traceable workflow.

  • Linked deviation-to-CAPA workflows
  • Root cause and impact assessment templates
  • Effectiveness verification tracking

Audit Trail & Logging

Time-stamped records of creates, updates, and deletes, with the user and the reason.

  • Supports ALCOA+ expectations for attribution and contemporaneous entry
  • User, timestamp, and reason on each change
  • Audit report export for an assessor

21 CFR Part 11 Support

Controls for electronic records and signatures that support FDA 21 CFR Part 11 requirements.

  • Electronic record lifecycle controls
  • Signature controls linked to the record
  • System access and authority checks

Electronic Signatures

Sign-off on results, batch releases, SOP approvals, and CAPA closures, with the controls 21 CFR Part 11 expects.

  • Meaning-of-signature prompts per action
  • Re-authentication when a signature is applied
  • Complete signature audit history

Statistical Process Control (SPC)

Monitor method performance over time with control charts, trend analysis, and automatic out-of-control alerts.

  • XmR, X-bar/R, and attribute control charts
  • Long-term method performance trending
  • Proactive alerts before failures escalate

Staff Competency & Proficiency Testing

Track analyst qualifications, training records, and external proficiency testing results in one compliance hub.

  • Training matrix and expiry alerts
  • PT/EQA result logging and review
  • Competency assessment workflows

See Quality, Compliance & Smart Search in action

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