Meet GxP requirements with traceable SDS management. From R&D labs to production floors, keep every chemical documented and audit-ready.
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Pharmaceutical and life science companies operate under strict regulatory frameworks — EU GMP, FDA 21 CFR, ICH guidelines — that require traceable documentation for every chemical used in R&D, QC, and production. A typical pharma facility manages hundreds of reagents, solvents, reference standards, and cleaning agents, each requiring a current safety data sheet with full audit trail. NextSDS provides a GxP-ready SDS management platform that automates chemical inventory tracking, supplier document validation, and regulatory substance screening. Every document action is timestamped and traceable, supporting the documentation integrity that GMP and GLP quality systems require.
Pharma R&D labs use hundreds of reagents, solvents, and intermediates that change frequently. Each substance needs a current, validated SDS linked to the correct lab location — NextSDS tracks this automatically across multiple departments and sites.
GMP and GLP require full traceability of all documentation. Every SDS must have a documented lifecycle — receipt, validation, access, and updates — with timestamps and audit trails that satisfy EU GMP Annex 11 expectations.
Pharma companies must track SVHC, CMR, and PBT substances used in production and R&D. NextSDS screens every chemical against 50+ regulatory databases and provides proactive alerts when substances face new restrictions or authorization requirements.
Every SDS in your system has a complete history: when it was received, who validated it, when it was last updated. Meet GMP documentation requirements without manual record-keeping. All actions are logged with timestamps for complete document lifecycle tracking.
Stay ahead of regulatory changes that affect your chemical inventory with automated horizon scanning. Continuous monitoring of REACH updates, CLP ATP amendments, SVHC candidate list additions, and substance authorization decisions relevant to pharma operations.
Manage chemical inventories across multiple lab and production sites from a single platform. Each location maintains its own register while headquarters retains oversight and control — essential for pharma companies with distributed operations across R&D, QC, and manufacturing.
Validate supplier SDS quality as part of your vendor qualification process with automated SDS validation. Track SDS compliance rates per supplier and generate documentation for quality audits — a measurable input for your approved supplier assessment program.
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NextSDS maintains a full audit trail of every SDS document — when it was received, who accessed it, when it was validated, and when it was last updated. This complete traceability supports GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), and GDP (Good Distribution Practice) documentation requirements. All document actions are timestamped and logged, providing the documentation integrity pharmaceutical quality systems require under EU GMP Annex 11 and 21 CFR Part 11 expectations.
Yes. Manage chemicals across R&D, QC, and production environments with location-specific inventories. Track reagent usage, monitor expiry dates, and ensure every substance has a current, validated safety data sheet. Each lab maintains its own chemical register while your EHS team retains a consolidated view — essential for pharmaceutical facilities managing hundreds of reagents, solvents, and intermediates across multiple departments.
All chemicals are automatically screened against REACH SVHC (Substances of Very High Concern) candidate lists, CMR (Carcinogenic, Mutagenic, Reprotoxic) classifications, PBT/vPvB substances, and pharma-specific restricted substance databases. You receive instant alerts when a substance in your inventory is affected by REACH authorization decisions, CLP ATP amendments, or new SVHC identifications — giving you time to find alternatives before restrictions take effect.
NextSDS provides API access and export capabilities that complement existing QMS (Quality Management Systems) and EHS platforms. Safety data can be exported in standard formats for integration with your pharmaceutical quality management workflows, LIMS systems, or ERP platforms. The platform is designed to serve as the authoritative source for chemical safety data that feeds into your broader quality ecosystem.
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