Paperless Inspection
Electronic Compliance Closed Loop
Zero paper from submission to archiving. E-signatures replace handwriting, electronic records replace paper notebooks, electronic archiving replaces filing cabinets. Compliance audit-ready out of the box, with green and low-carbon goals achieved in one move.
Six Core Capabilities Building the Paperless Closed Loop
Refined around real-world lab paper pain points, every capability has been validated across thousands of laboratories.
Electronic Submission
Online client ordering, QR code verification, one-click e-contract signing. Eliminate courier and fax of paper submission forms — submission info syncs in real time to LIMS sample registration.
Electronic Lab Notebook
Structured templates + free annotations + chart embedding + timestamp locking, fully replacing paper lab notebooks. Supports formula calculations, data validation, and version comparison.
Three-Level E-Signature
Operator / Reviewer / Approver three-level electronic signature, supporting CFCA digital certificates and biometrics. Compliant with 21 CFR Part 11 e-signature standards with legal equivalence to handwritten signatures.
Electronic Archiving
WORM (Write Once Read Many) long-term preservation, intelligent tiered archiving strategy, full-text search with sub-second retrieval. One-click regulatory audit export — eliminate filing cabinets for good.
Audit Trail
Field-level Audit Trail fully records all data changes — who, when, what was changed, and why. Tamper-proof and non-repudiable, meeting FDA / EMA / NMPA inspection requirements.
ESG Carbon Reduction
Over 80% annual paper savings with auto-generated carbon footprint visualization reports. Quantified proof of green lab transformation, supporting corporate ESG reporting and sustainability goals.
Complete Functional Module Matrix
Ready-to-use standard modules, combinable on demand with deep customization, covering every node of the inspection workflow.
E-Submission
Client portal online ordering + QR code verification + one-click e-contract, submission info synced to LIMS in real time.
ELN Electronic Records
Structured templates + rich text editing + formula calculations + chart embedding, fully replacing paper lab notebooks.
E-Signature
CFCA digital certificates / biometric three-level e-signing, 21 CFR Part 11 compliant, legally equivalent to handwriting.
Audit Trail
Full-field Audit Trail + operation logs + change reason records. Who, when, what, why — fully traceable.
E-Archiving
WORM non-erasable storage + auto tiered archiving + long-term retention strategy. Full-text search with sub-second retrieval, one-click regulatory audit export.
Compliance Reports
GMP / GLP / CNAS / ISO 17025 standard templates, auto-generating compliance reports and audit readiness packages.
Data Integrity
ALCOA+ self-assessment tools + data integrity risk evaluation. Proactively identify compliance gaps and continuously improve data governance.
ESG Dashboard
Paper consumption / carbon emissions / electricity usage visualization dashboard. Quantified proof and continuous monitoring of green lab transformation.
Five-Step Implementation Delivery Path
Standardized methodology — from e-submission to e-archiving, averaging 8 weeks for end-to-end go-live.
Digital Submission & Sample Reception
Online client ordering, QR code verification, e-contract signing. Submission info syncs in real time to LIMS registration, eliminating courier, fax, and manual data entry of paper forms.
Raw Data Capture & Structured Recording
Structured templates + rich text editing + chart embedding + formula calculations. Instrument data auto-captured and back-filled; timestamp locks every modification — fully replaces paper lab notebooks.
Three-Level E-Signing & Compliance Locking
Operator / Reviewer / Approver three-level electronic signature workflow. Supports CFCA digital certificates and biometrics; each signature carries an immutable timestamp and signature reason, 21 CFR Part 11 compliant.
Audit Trail & Data Integrity Verification
Field-level Audit Trail fully records all data changes. ALCOA+ principles auto-verified — whether data is attributable, legible, contemporaneous, original, and accurate. Anomalies auto-flagged; complete traceable review path.
WORM Long-Term Preservation & Inspection Readiness
WORM non-erasable storage ensures archived data cannot be tampered with. Intelligent tiered archiving strategy, sub-second full-text search. One-click export of complete electronic record package during regulatory inspections — confidently prepared for FDA / EMA / NMPA audits.
Make Digitization Intelligent — Starting Today
1-on-1 consultation with senior solution experts; receive a custom blueprint in 30 minutes.
Covering GMP / GLP / CNAS / ISO 17025 full compliance scenarios.