Top 10 Pharma Company Reaches FDA Audit Readiness with GxP-Validated Device Management

Teceze implemented validated device management for a top-10 pharmaceutical company, enabling GxP-compliant operations across manufacturing and clinical functions. The result: 55,000 devices governed with full FDA compliance, 100% audit readiness, zero compliance violations, and seamless evidence collection.

About the Client

Pharmaceutical Company is a top-10 pharmaceutical company with validated manufacturing systems and clinical trial operations across multiple continents. The organization manages one of the most heavily regulated device estates in pharma requiring GxP compliance per FDA 21 CFR Part 11, validated change management, and continuous audit-trail logging.

At a glance

Industry
PHARMA
Headquarters
Global operations
Products & services
Validated device management, GxP compliance, clean room infrastructure
Challenge
55,000 devices across GxP environments, FDA 21 CFR Part 11 compliance mandatory, clean room restrictions

Success highlights

  • 55,000 devices governed with full GxP validation
  • FDA 21 CFR Part 11 compliance across manufacturing and clinical operations
  • 100% audit readiness with automated evidence collection
  • 3Zero compliance violations across three inspection cycles

The challenge

Corporate meeting

GxP device management at pharma scale

The constraint: FDA 21 CFR Part 11 compliance, clean room restrictions, complex validation documentation

Pharmaceutical Company faced a compliance-driven constraint: FDA 21 CFR Part 11 requires validated systems, electronic signatures, tamper-proof audit trails, and documented change management for any system touching drug development or manufacturing. Clean room manufacturing requires sealed devices preventing contamination risks.

The engagement demanded implementing validated MDM platform with full IQ/OQ/PQ documentation, configuring electronic signature workflows, deploying clean room compliant kiosk profiles, and preparing for government inspections.

Our approach

Validated MDM platform with segregated GxP estates

Teceze designed and implemented validated Intune environment with full IQ/OQ/PQ documentation: segregated GxP device policies, e-signature workflows enforced at device level, clean room kiosk profiles with device locking, and automated compliance reporting.

From challenge to transformation, the solution included:

Validated Intune deployment with IQ/OQ/PQ

Installation Qualification documenting system configuration. Operational Qualification validating behavior. Performance Qualification proving system performance over time.

Segregated GxP and non-GxP device estates

Separate device groups with distinct policies. Clear labeling preventing misconfiguration. Automated compliance checks preventing policy drift.

Electronic signature enforcement

Multi-factor authentication for regulatory submissions. Digital signatures with timestamp and user identity. Non-repudiation proving authorized user action.

Regional caching for model assets

Local caching of large design files reducing re-transmission. CDN delivery of frequently used libraries.

Governance and Reporting Cadence

Operational transparency and stakeholder alignment are critical to program success. A layered governance model keeps program health and costs visible:

Cadence Forum Focus
Daily Compliance stand-up Device validation status, change management approvals, audit trail integrity, incident reporting
Weekly Compliance review Device deployment metrics, GxP compliance status, validation documentation status, at-risk devices
Monthly Governance call Overall compliance posture, regulatory audit preparation, quality assurance integration, FDA readiness
Quarterly Business review Program health, compliance certification status, government inspection history, expansion roadmap
The Results: Full Deployment Metrics

Proven results at scale

55KDevices Governed
GxPFully Validated
FDAAudit Ready
55,000 Devices governed with full GxP validation
100%audit readiness with automated evidence collection
90% Reduction in audit preparation time

What the client says

“Regulatory compliance is not optional in pharma—it is existential. Every device touching drug development must be validated and auditable. Teceze built infrastructure where compliance is architected in. Our manufacturing teams move faster because they trust the system. FDA inspectors audit with confidence.”

—- Pharmaceutical Company — Chief Compliance Officer, Regulatory Affairs

Delivery partnership

How Teceze Executes on This Engagement

The engagement is delivered by Teceze as the primary regulatory and infrastructure partner. Teceze provides validated MDM architecture, GxP compliance design, electronic signature configuration, clean room device lockdown, regulatory reporting automation, and ongoing optimization.

Looking ahead

Sustaining performance and expanding capability

With the first 16 months establishing proven provisioning velocity, focus shifts to advanced capabilities and cost optimization.

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