Biotechnology
A Breakthrough WMS for Biotech Ops
Biotech companies run under strict GxP guidelines where precision, documentation, and accountability are not optional.
Footprint® WMS makes biotech supply chain compliance operational with built-in validation tools, 21 CFR Part 11, EU Annex 11 support, and full chain-of-custody traceability, so every batch, sample, and transaction meets the highest regulatory standards.
Detailed Traceability From Research To Release
Biotech warehousing requires precision at every stage of the supply chain. From cold, frozen, and cryogenic storage to sample handling and controlled distribution, every movement must preserve integrity and maintain chain of custody.
You need complete visibility into each batch and environment, ensuring products, data, and documentation stay aligned across research, manufacturing, and clinical operations.
Validation-Ready Platform
Simplify IQ/OQ/PQ testing and maintain documented change control for every configuration.
Electronic Records Compliance
Capture electronic signatures and audit trails aligned with FDA and EU Annex 11 requirements.
Temp & Environmental Monitoring
Track cold, frozen, or cryogenic storage materials with automated alerts and data logging.
Chain-of-Custody Traceability
Link every movement, transaction, and user action to its corresponding lot or sample.
David Hamilton
Vice President of cGMP Warehousing, Tobin Scientific
Our company deals with pharmaceutical inventory. Our pharmaceutical clients need to have a high degree of traceability of the materials going into all of their manufactured batches as government regulations require that level of genealogical data. Datex met that standard.
The Foundation for a Secure, Compliant Biotech Warehouse Operation
Built for the complexity of GxP compliance, Footprint WMS easily turns regulatory requirements into everyday workflows. From environmental monitoring to chain-of-custody tracking, it keeps your biotech warehouse inspection-ready, and ensures you are always in control of your biotech supply chain.
Stay Audit-Ready Every Day
- Complete 21 CFR Part 11 and EU Annex 11 support for GxP environments
- Secure electronic signatures with full audit trails
- Validation documentation and access controls for QA approval
Protect Every Batch and Sample
- Temperature mapping and continuous zone-level monitoring
- Lot, serial, and expiry tracking with quarantine management
- Rapid recall and deviation tools for regulatory response
Integrate Data with Your Lab and Enterprise Systems
- Connect seamlessly to LIMS, ERP, and MES platforms
- Sync chain-of-custody data across research and production systems
- Extend functionality via Datex Studio and validated APIs