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AI-ENABLED SMART FM FOR PHARMACEUTICAL

GxP Compliance Maintained. Calibration Zero-Miss. Every Record Audit-Ready.

Pharmaceutical facility management operates under GxP obligations that leave no room for missed calibrations, incomplete maintenance records, or unvalidated changes. MIRA enforces your compliance framework continuously — so your engineering team focuses on maintaining equipment, not managing paperwork.

GxP compliant records
21 CFR Part 11 validation audit trail
Zero overdue calibrations check

0%

Overdue Calibrations

0%

Regulatory Audit Readiness

-30%

Quality Control Overhead Cut

Statutory compliance risks in pharmaceutical operations.

Overdue calibrations can halt shipping immediately.

A single instrument out of tolerance or overdue for check triggers batch deviations and quality holds.

GxP compliance requires manual, paper-intensive validation trails.

Coordinators spend more time signing checklists, logging LOTO entries, and verifying credentials than maintaining assets.

Paper audit trails are vulnerable to data entry errors.

An auditor finding one missing date or technician signature can compromise the regulatory standing of the entire site.

Cleanroom maintenance risks contamination events.

Executing PM inside class A-C environments needs strict compliance with PTW procedures, LOTO isolation, and hygiene regulations.

FacilityFlow Solves This

Zero overdue calibrations.

Every instrument calibrated on schedule. Signed certificates generated automatically. Multi-site calibration dashboard always current.

GxP-compliant maintenance records.

Every work order, PM completion, and LOTO transaction logged with full traceability. Electronic signatures. Complete audit trail.

Cleanroom PM without contamination risk.

MIRA schedules cleanroom maintenance in strict accordance with contamination control procedures. PTW enforced. No shortcuts.

21 CFR Part 11 aligned audit trail.

Every system action timestamped, attributable, and exportable. FDA inspection-ready, permanently.

See How It Works

Key Outcomes

What FacilityFlow delivers for pharmaceutical manufacturing.

Calibration Manager

Automated calibration triggering, digital certificate uploads, and warning notifications

Zero Overdue

GxP Log Trail

Secure, attributable maintenance logs meeting GxP quality guidelines

FDA Ready

21 CFR Part 11 Audit

Digitally signed work orders and LOTO logs with trace audits

Fully Attributable

Cleanroom Guard

Hygiene compliance gates and PTW checklists for contamination zones

PTW Enforced

Pharma Facility Results

Outcomes recorded across MIRA-monitored pharma manufacturing sites

0

Overdue calibrations

Across all multi-site instrumentation

0%

Audit compliance

GxP and 21 CFR Part 11 ready

0%

Admin overhead cut

For pharmaceutical quality controllers

0 hours

Validation speed

To get live on your first environment

Based on 2024 customer survey of 250+ companies

FDA Ready — 100%

Your facility compliance is too important to leave to spreadsheets.

Schedule a pharma-specific demonstration of our GxP validation tools.