GMP Inventory Management

Operate with confidence using an inventory platform crafted specifically for regulated biotech and life science organizations. This solution streamlines operations from material specification management and inbound inspections to comprehensive tracking and warehouse management. Whether scaling GMP manufacturing or managing GxP CRO services, it digitizes quality controls, ensures compliance, and keeps you audit-ready efficiently.

Robust GMP Inventory Controls and Compliance

This platform helps you stay ahead of regulatory requirements with state-of-the-art inventory compliance for GMP. It digitizes the entire inventory lifecycle from material intake to audit reporting, meeting FDA 21 CFR Part 11 and EU Annex 11 standards, and has supported successful FDA and MHRA audits.

Key GMP Inventory Capabilities:

• Material Specification Management: Easily define and manage raw material specifications and link them with inbound inspection protocols.
• Inbound Inspection and Segregation: Digitally capture inspections, automate label generation, and organize materials by GMP status.
• Warehouse Operations: Efficiently manage segregated GMP storage alongside R&D inventory using tote usage, quarantine, and FEFO principles.
• End-to-End Material Status and Compliance: Track every item’s custody chain with a single view across all locations for seamless team collaboration.

Streamline GMP Inbound Inspection

Ensuring every material meets quality standards before production is crucial for GxP compliance. The inbound inspection tools simplify processes, train teams easily, and delegate confidently.

• Material Specifications Document Management: Online version control and approval workflows link approved materials with templates for inspection criteria.
• Unique Goods Receiving Numbers: System-generated numbers ensure traceability of raw materials.
• Customizable Labeling: Generate labels for quarantine, approvals, or rejections from the system.
• Digital Inspection Results Management: Record and store inspection results with pass/fail outcomes and comments.
• Quarantine Management: Automatically quarantine materials upon receipt and release them only after passing inspection.

Digital Validation, Audit, and Reporting Made Easy

Computer system validation, audit readiness, and automated reporting are central, making compliance straightforward.

• Access Controls: Configure user permissions and workflows to meet GMP, GxP, and internal protocols.
• Electronic Signatures: Ensure records are legally admissible and comply with 21 CFR Part 11.
• Complete Audit Trails: Capture every inventory event in unalterable logs for easy audit retrieval.
• Easy Validation: Full validation packs with on-site support, enabling rapid implementation.

Why Choose Our Solution?

With expertise in GMP inventory controls combined with best-in-class management software, it offers unmatched operational clarity and compliance confidence. Rapid implementation and ongoing support are ensured, drawing from experiences with leading biotech and pharma companies.