Enterprise Asset Management
Precision. Compliance. Excellence.

Enterprise Asset Management for Life Sciences

Cloud-based, audit-ready asset management solutions designed for regulated industries. Maintain compliance through robust maintenance, calibration tracking, and reliability programs.

21 CFR Part 11 Compliant cGMP Aligned ISO 17025 Traceability

The Cost of Non-Compliance in Life Sciences

Poor asset management leads to significant financial and operational consequences beyond fines and penalties.

$2.3M

Average Regulatory Fine
Per compliance violation

45%

Downtime Reduction
With proper asset management

25%

Cost Savings
In maintenance and operations

100%

Audit Readiness
With compliant EAM

Effective Asset Management Strategy

Our comprehensive approach ensures compliance while optimizing asset performance and operational efficiency throughout the entire asset lifecycle.

Asset Criticality Assessment

Classify critical assets to prioritize maintenance and allocate resources based on risk and regulatory impact.

  • Critical Process Parameter identification
  • Risk-based asset classification
  • Resource allocation optimization

Lifecycle Management

Manage assets from commissioning to decommissioning, ensuring compliance throughout their lifecycle.

  • Installation & commissioning support
  • Validation protocol development
  • End-of-life planning

Risk-Based Maintenance

Implement maintenance strategies that minimize equipment failures while ensuring regulatory compliance.

  • Failure mode analysis
  • Predictive maintenance scheduling
  • Reliability-centered maintenance

Compliance Documentation

Maintain comprehensive audit trails and documentation meeting regulatory requirements.

  • ALCOA+ compliant records
  • Electronic signatures
  • Audit trail generation

Understanding Regulatory Requirements

Current Good Manufacturing Practices (cGMP)

Equipment must be appropriately designed, calibrated, and maintained to ensure consistent product quality.

Validation and Qualification

Demonstrate equipment meets intended purposes through IQ, OQ, and PQ protocols.

Data Integrity (ALCOA+)

Maintenance and calibration data must be Attributable, Legible, Contemporaneous, Original, and Accurate.

Compliance Consequences

Obvious Costs

  • Fines and penalties
  • Regulatory sanctions
  • Legal fees

Ready to Optimize Your Asset Management?

Contact our experts for a comprehensive assessment of your asset management needs. We're all in for your compliance success.

Schedule Your Assessment