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Instrument Qualification

Lab Instrument Qualification

Qualify Your Lab Instruments Digitally, Completely, Once.

From balances to HPLC systems, Valkit.ai gives you a complete qualification package — validation plan, requirements, risk assessment, IQ/OQ/PQ protocols, data capture, and traceability — in a single platform with built-in AI augmentation.

Risk-Based Approach

Scale qualification to instrument complexity. Different instruments require different qualification depths — from simple calibration through full DQ/IQ/OQ/PQ.

Group A

Auxiliary Equipment

Instruments without a measuring function or with common prerequisites for calibration. Manufacturer's specification matches user requirements.

Typical Valkit Package

Validation Plan + Requirements + IQ with manufacturer calibration certificates. Minimal test execution scope.

Group B

Standard Equipment

Standard instruments providing simple measured values or physical parameters (temperature, pressure, flow). Requires calibration and verification.

Typical Valkit Package

VP + REQ + RA + IQ/OQ with calibration verification test steps and data capture tables for measurement recording.

Group C

Complex & Computerized

Computer-controlled analytical systems where users have specific requirements for functionality, operational and performance limits. Full qualification required.

Typical Valkit Package

Full VP + REQ + RA + CS + IQ + OQ + PQ (or CQ) + Summary Report + Trace Matrix with comprehensive test execution.

Qualification Lifecycle

Four phases, one platform. Valkit maps to the standard DQ/IQ/OQ/PQ lifecycle with dedicated document types and workflows for each phase.

Phase 1

Plan & Specify

Define qualification strategy, capture user requirements, and assess functional risks with configurable risk dials.

VPREQRACS

Phase 2

Installation

Verify instrument installation, software configuration, environmental conditions, and documentation completeness.

IQIQ Summary

Phase 3

Operational

Test instrument functions against specifications under controlled conditions. Verify security, audit trail, and data handling.

OQOQ Summary

Phase 4

Performance

Confirm instrument performs consistently under actual conditions of use with real samples and analytical methods.

PQPQ SummaryTMX

Validation Packages

Every document in one package. Select the document types you need during setup, then build, review, approve, and execute — all within one controlled workspace.

  • Core documents: Validation Plan, Requirements, Risk Assessment, Configuration Specification
  • Qualification protocols: IQ, OQ, PQ individually or combined as a Combo Qualification (CQ)
  • Summary Reports generated per executable document with execution results, deviations, and conclusions
  • Trace Matrix auto-generated from requirement → risk → test step links
  • Custom document types for organization-specific needs (calibration records, SOPs, etc.)

AI Augmentation

Multiple content creation options: manual entry, file upload, generative AI, and agentic AI. The AI considers your package context — system details, regulations, and risk settings — to produce relevant content.

  • Gen AI creates requirements, risk assessments, and test steps based on your system description and regulatory scope
  • Agentic AI processes up to 50,000 characters of unstructured data (manuals, SOPs, release notes) into structured requirements
  • Test scripts auto-generated based on risk assessment results, linked requirements, and GAMP category selection
  • SOP Audit compares your document content against your SOP or template for completeness and consistency
  • All AI-generated content is fully editable — add, modify, or remove any element before submission

Test Execution

Run IQ, OQ, and PQ protocols directly in the platform. Each test step supports structured data capture tables for measurements, pass/fail results, evidence files, and observations.

  • Data capture tables collect structured measurements in configurable column formats (text, number, date)
  • Pass/fail recording with immediate deviation generation on test failures
  • Evidence capture from mobile devices — attach photos, screenshots, and files directly to test steps
  • Deviations tracked through a collaborative resolution workflow with corrective actions
  • Executable Summary Reports per qualification document with test results, deviations, and conclusions
  • Real-time progress tracking: total steps, completed, passed, failed, remaining
OQ Test: Temperature Accuracy Verification
SetpointReadingToleranceResult
25.0 °C25.1 °C± 0.5 °CPass
37.0 °C37.2 °C± 0.5 °CPass
45.0 °C46.1 °C± 0.5 °CFail
Failed step triggers deviation workflow; resolution and re-test managed in-platform.

Build Once, Qualify Many

Qualified one HPLC? Clone the entire package — documents, content, test structures, and data capture tables — for the next unit. Update tags for site, serial number, and model, and you're ready to execute in minutes.

  • Standard clone copies all documents, structure, content, settings, and stakeholder assignments
  • Clone with Data Capture additionally preserves table structures, test step definitions, and test case organization
  • Global Clone deploys packages across organizations for multi-site instrument qualification programs
  • Reusable tag libraries for metadata — location, serial number, model, asset ID — update across all documents instantly
  • Cloned packages get new IDs and start in Initiated status, fully independent from the original

Integrations

Connect your lab ecosystem. Import data directly from the tools your lab already uses.

JiraConnected

Import requirements and tickets for traceability and validation of lab instrument software.

Azure DevOpsConnected

Synchronize requirements for instrument software validation and computerized system qualification.

21 CFR Part 11EU Annex 11EU GMP Annex 15ISO 27001 CertifiedUSP <1058>ISO/IEC 17025

Data Integrity & Compliance

Built for regulated laboratories. Electronic signatures, unalterable audit trails, document workflow control, deviation management, role-based access, and full traceability.

  • PIN-authenticated e-signatures with signer name, date/time, and role. Signatures linked to electronic records.
  • Secure, computer-generated, time-stamped audit trails. Record changes do not obscure previously recorded information.
  • Documents route through Draft → Review → Signature → Approved → Execute → Post-Execution. System enforces permitted sequencing.
  • Failed test steps auto-generate deviations with collaborative resolution workflow and corrective action tracking.
  • RACI-based stakeholder assignments. Execute permission cannot hold Approve rights on the same document.
  • Trace Matrix auto-generated from linked requirements, risks, and test steps for complete traceability.

Lab instrument qualification from validation plan through summary report — with AI-augmented requirements, risk assessment, IQ/OQ/PQ protocols, data capture, and traceability. Standard clone, clone with data capture, or global clone for multi-site programs. PIN-authenticated e-signatures and unalterable audit trails built in.