Capabilities

Focused tools for high-consequence quality work.

Vizir Analytical develops VIQMS, a controlled, evidence-linked decision-support platform for pharmaceutical quality operations. VIQMS is designed to structure source information, surface uncertainty, and support qualified review—not to replace accountable quality judgment.

Capability 01 · VIQMS

Quality-event intelligence

VIQMS supports the intake, structuring, assessment, and routing of GMP/QMS events. It brings relevant facts and context into a controlled workflow so teams can make more consistent, reviewable decisions across laboratory, manufacturing, and quality-system records.

Ingest · Structure

Bring relevant records together

Organize source material from quality narratives, laboratory records, batch documentation, deviation reports, and related context into a structured review package.

Assess · Route

Support consistent handling

Apply defined case types, risk factors, and escalation logic to help route events to the appropriate workflow and level of qualified review.

Ground · Explain

Keep evidence visible

Retain the connection between an assessment and the source information used to support it, helping reviewers inspect what is stated, missing, uncertain, or contradictory.

Draft · Review

Prepare reviewable documentation

Support preparation of structured, source-grounded investigation content and review notes while preserving the need for qualified authoring and approval.

Check · Escalate

Surface uncertainty

Confidence gates, completeness checks, and contradiction flags are intended to identify cases that need additional evidence or direct human evaluation.

Trace · Govern

Maintain an inspectable path

Controlled versions, structured outputs, and defined review steps support traceability across the lifecycle of a quality-support workflow.

Potential use cases

  • Laboratory and quality events: preliminary organization and assessment of OOS, OOT, invalid-test, deviation, and data-integrity-related records.
  • Investigation support: structured fact capture, source review, issue routing, and preparation of draft material for qualified reviewer consideration.
  • Quality-system consistency: common case structures and escalation criteria across recurring event types and review teams.
  • Inspection readiness: clearer retrieval of linked evidence, review status, and the rationale supporting an assessment.
Decision support only. VIQMS does not release batches, approve investigations, determine product disposition, or replace the judgment of authorized QA personnel.
Methodology

Designed for controlled use in regulated quality environments.

Vizir Analytical uses a lifecycle-oriented approach: define the intended use, identify the relevant source information, establish decision and escalation boundaries, evaluate performance against appropriate benchmarks, and maintain controlled change over time.

Risk-proportionate

Controls reflect impact

Review rigor and escalation expectations are designed to reflect potential impact to product quality, patient safety, data integrity, and regulatory compliance.

Evidence-linked

Source context matters

Outputs are designed to remain connected to the records and evidence that support them, enabling a reviewer to understand the basis and limits of an assessment.

Lifecycle-managed

Ongoing oversight

Evaluation, monitoring, version control, and controlled change are treated as ongoing responsibilities rather than one-time deployment tasks.

Discuss a quality-system use case.

For demonstrations, collaborations, or conversations about controlled pharmaceutical quality intelligence with VIQMS.

Contact us