PHARMACEUTICAL QUALITY INTELLIGENCE

From quality data
to defensible
decisions.

VIQMS brings GMP events, laboratory records, and quality-system data into a controlled quality-intelligence workflow—so teams can assess risk, prepare grounded documentation, and retain clear human accountability.

Trusted in pharmaceutical quality and workflow: Ingest, Structure, Assess, Draft, Review and decide
What we do

Quality intelligence that remains explainable

Pharmaceutical quality teams work across complex narratives, records, procedures, and regulatory expectations. Vizir Analytical designs controlled systems that turn this information into structured, reviewable, and defensible decision support.

Organize · Route

Quality-event intelligence

Transform incoming quality narratives—from deviations and laboratory events to batch-record observations—into defined workflows with consistent categorization and clear escalation paths.

Ground · Explain

Evidence-linked analysis

Connect findings to source records and quality-system evidence, helping reviewers distinguish what is stated, supported, uncertain, or still requires investigation.

Review · Govern

Human accountability

Use confidence gates, contradiction checks, and reviewer controls so that qualified personnel retain ownership of conclusions and final quality decisions.

21 CFR Part 11 EU GMP Annex 11 GAMP 5 ICH Q9(R1) ICH Q10 ALCOA+
Capabilities

Focused tools for high-consequence quality work

VIQMS

GMP/QMS event assessment

Support consistent triage and structured assessment of OOS, OOT, invalid-test, investigation, and data-integrity events while preserving reviewer control at each meaningful decision point.

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Decision support only. Vizir Analytical tools do not make batch-release, approval, or final quality decisions. Authorized quality personnel remain responsible for conclusions, approvals, and regulatory determinations.
Methodology

Designed for systems that must withstand review

  • Risk-proportionate governance. Controls reflect potential impact to patient safety, product quality, data integrity, and regulatory compliance.
  • Source-grounded operation. Outputs are designed to remain connected to the underlying record, evidence, and relevant context.
  • Transparent limitations. Uncertainty, boundary cases, and model limitations are surfaced for review rather than hidden behind automated confidence.
  • Lifecycle oversight. Versioning, evaluation, monitoring, and controlled change are treated as continuing responsibilities, not one-time deployment tasks.

Bring more structure to your quality decisions

Request a demonstration or consultation to discuss where controlled, evidence-linked quality intelligence can support your team.

Contact us