The Challenge

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.

Capabilities

Key Outcomes

What FacilityFlow delivers for pharmaceutical manufacturing.

  • Calibration Manager

    Automated calibration triggering, digital certificate uploads, and warning notifications

  • GxP Log Trail

    Secure, attributable maintenance logs meeting GxP quality guidelines

  • 21 CFR Part 11 Audit

    Digitally signed work orders and LOTO logs with trace audits

  • Cleanroom Guard

    Hygiene compliance gates and PTW checklists for contamination zones

Impact by the numbers

0
Overdue calibrations
Across all multi-site instrumentation
100%
Audit compliance
GxP and 21 CFR Part 11 ready
30%
Admin overhead cut
For pharmaceutical quality controllers
48hours
Validation speed
To get live on your first environment

Your facility compliance is too important to leave to spreadsheets.

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

Book a Demo