- Stringent regulatory oversight from FDA, EMA, and global health authorities requires continuous documentation and audit readiness
- GMP and GDP compliance gaps appear when visitor logs, training records, and environmental controls aren't digitized
- Contamination risks increase with manual check-in processes that don't enforce gowning, hygiene protocols, or cleanroom entry requirements
- Supply chain complexity results from managing contract manufacturers, clinical trial vendors, and third-party logistics providers
- Audit fatigue from fragmented systems that make evidence gathering slow and error-prone
- Validation burdens grow as paper-based processes lack the 21 CFR Part 11 compliant digital trails regulators expect
Trusted by 600+ Manufacturers
FacilityOS for
Medical Devices, Pharma
& Life Sciences
FacilityOS empowers your team to strengthen compliance, protect product integrity and centralize operations—all within a single, innovative platform.
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Rising pressures are impacting compliance, quality, and operational efficiency across sites.
Facing the Demands of
Modern Life Sciences Manufacturing
Next generation facility management
Turn challenges into
opportunities by:
- Enabling continuous audit readiness with FDA 21 CFR Part 11, EU GMP Annex 11, and ISO 13485 compliant digital trails
- Simplifying vendor and contractor qualification with centralized credential management, training verification, and compliance-tied access controls
- Protecting product integrity through documented environmental monitoring, material tracking, and controlled access to cleanrooms and restricted areas
- Centralizing quality systems into a single source of truth with real-time reporting across R&D labs, manufacturing plants, clinical sites, and distribution centers
- Accelerating validation with system documentation, audit trails, and electronic signatures that meet regulatory requirements
SAVE TIME
- 90% reduction in time to process visitors, clinical monitors, and contractors at check-in
- Zero manual logbooks — create inspection-ready reports in seconds
- Vendor training time reduced by 90%+ with integrated GMP orientations at check-in
BE EFFICIENT
- Streamlined courier and sample deliveries for faster turnaround with complete chain of custody
- 50% faster logistics for investigational products and critical materials with zero lost packages
- Real-time visibility of who is on site and in which validated areas
STAY COMPLIANT
- Audit-ready documentation that meets FDA 21 CFR Part 11, EU GMP Annex 11, and ISO 13485 requirements
- Critical evacuation and accountability benchmarks met within 7 minutes during emergency response drills
- Automated compliance verification flags expired credentials and blocks non-qualified personnel at entry
Real-time visibility of who is on site, whether they're GMP-trained and approved, with built-in alerts.
Centralized vendor qualification to track and automate contractor compliance processes including training, insurance, and technical agreements.
Emergency accountability with digital mustering, roll calls, and reporting that meet EHS and regulatory expectations.
Complete chain of custody for clinical samples, investigational products, controlled substances, and critical materials.
Corporate quality oversight with dashboards to standardize compliance across manufacturing sites, R&D labs, clinical facilities, and distribution centers.
90+ Open APIs and integrations with industry systems.
Quality
Assurance & Regulatory Affairs
- Centralize vendor and contractor qualification documents in one place
- Automate expiration alerts and monitor compliance in real-time
- Generate audit-ready reports with complete traceability and electronic signatures
- Maintain 21 CFR Part 11 compliant audit trails for all facility access
EHS Managers
Environment, Health & Safety
- Strengthen emergency readiness with scenario-based profiles, mustering, and drill records
- Apply consistent GMP and safety processes across multiple facilities
- Track contractor safety training and site-specific certifications
- Document emergency response for regulatory and insurance requirements
Operations
Production, Maintenance
- Speed visitor and contractor check-ins with pre-registration and kiosks
- Streamline receiving for investigational products and clinical supplies
- Gain real-time visibility of materials and sample custody with complete chain of custody
- Reduce downtime with faster, compliant access for equipment vendors and service providers
Facility Managers
Operations, Internal Processes
- Scale operations with unlimited site-level licenses
- Monitor risk and performance through real-time dashboards and analytics
- Extend capabilities with open APIs and system integrations (QMS, LIMS, ERP, BMS)
- Standardize operations and compliance across manufacturing, R&D, and distribution sites
Security
Access Control, Clearence
- Ensure only qualified and GMP-trained personnel gain site access
- Activate emergency protocols to support fast, compliant response
- Control access to cleanrooms, controlled substance storage, and validated areas
- Screen materials and personnel through required checkpoints
Facility, Asset & Visitor Management Modular Platform
Keep track of on‑site visitors & contractors.
Centralize & automate contractor compliance processes.
Digitize all stages of emergency & evacuation management.
Track packages across the entire chain of custody.
Extend the benefits of access control to contractors.
