Pharmaceutical
GxPCompliance ready
AIContamination prevention
21 CFRPart 11 compliant
Pharmaceutical

Validated, compliant, and predictive maintenance for pharma.

Pharmaceutical manufacturing operates under the most stringent quality and regulatory requirements of any industry. Equipment reliability directly impacts product quality, patient safety, and regulatory standing. Monitory delivers GxP-compatible predictive maintenance that keeps your lines compliant and your products flowing.

Key Challenges We Solve

  • FDA 21 CFR Part 11 and GMP compliance for all maintenance activities
  • Cleanroom environments with restricted access for maintenance
  • Product contamination risk from equipment degradation
  • Extensive validation requirements for any system changes

Monitory Solutions

  • GxP-compatible monitoring with full audit trails and electronic signatures
  • Non-invasive vibration monitoring that works in cleanroom environments
  • Automated maintenance documentation meeting regulatory standards
100%

Audit-ready documentation

60%

Reduction in batch deviations

40%

Faster maintenance qualification

The cost of a stop

$500,000 per batch

Typical cost of unplanned downtime for pharmaceutical batch. Lost revenue, work-in-progress losses, safety and environmental exposure all add to it.

Source: ARC Advisory Group, Trends and Technologies in PLM

Our work in Pharmaceutical

Condition monitoring we have delivered

Baxter International

Medical products manufacturing

Tactical Edge supported Baxter's Amazon Monitron program, which watches manufacturing equipment so technicians can schedule maintenance instead of answering emergencies.

“Amazon Monitron has given us the actionable data needed to maintain the thousands of manufacturing assets in our facilities, allowing us to predict and preempt unplanned equipment downtime.”

Start with a free site visit

Half a day on your floor, a business case from your records, and a working-backwards plan for your critical assets.