Industries · Chemicals

One raw material changes supplier.The SDS and the dossier follow it.

Built for specialty chemical manufacturers supplying pharma, food, and industrial markets, where a formulation or process change has to stay traceable across quality, EHS, and the regulatory dossier, and hold up in a GMP or REACH audit.

Built for specialty and pharma-supply chemical makers

  • REACH
  • TSCA
  • OSHA PSM
  • GHS / CLP
  • ICH Q7

The decision lives in the thread, not the change log.

Incumbents track a change-log entry. Unifize reconstructs the decision trace across every function a process or formulation change touched, and every regulatory notification it triggered.

When the auditor is on site, someone reconstructs it.

The reconstruction always lands on someone. Find your seat, and see what you own when the trace has to hold up at a GMP or REACH audit.

Quality leadership

Every change and deviation decision stays reconstructable.

See the quality solution →

Operations leadership

Cross-functional disposition and change decisions move on one accountable thread.

Regulatory & Product Stewardship

Substance changes flow into the REACH, TSCA, and SDS dossier and into customer notifications.

Regulatory affairs →

EHS & Compliance

Process safety reviews, incident investigations, and management-of-change decisions are captured where they happen.

Process Development & Scale-up

Formulation and process changes move fast with their rationale sealed to the record.

See the change control solution →

Change, deviation, suppliers, process safety. One trace.

Each runs with REACH, GMP and process safety built in. Start with the one that costs you most.

Quality

From the first batch on a changed material to a CAPA that holds at the next audit.

  • Deviation Management
  • CAPA & Effectiveness
  • Batch Record & CoA Review
  • Nonconformance / MRB
See the quality solution →

Supplier Management

Raw-material changes assessed for spec, SDS and customer impact first.

  • Supplier Qualification
  • Supplier Change Notification
  • Incoming Inspection / MRB
See the supplier solution →

Compliance

Process safety, incidents and the REACH / TSCA dossier on governed records.

  • Process Safety Management (PSM)
  • Incident Investigation
  • Regulatory Dossier (REACH / TSCA)

Document & Records Control

SDS and specifications approved once, then distributed with receipt confirmed.

  • SDS & Specification Control
  • Document Control

Built to sit beside the systems that already run your plant, not to replace them.

  • Coexistence, not replacement

    Unifize sits alongside the ERP, EHS platform, QMS, and LIMS you already run. It replaces the ungoverned channels where the decision trace goes missing, not your systems of record.

  • Auditable e-signatures

    Every approval is captured as an attributable, time-stamped electronic signature, so the decision trace is the audit trail your pharma and food customers ask for, not a reconstruction.

  • GMP and REACH questions, answered directly

    Batch record control, change-management impact, supplier qualification depth, and materials-compliance posture are walked through with your team before anything touches a controlled record.

The moments that start a clock you don't control.

Statutory and customer deadlines, not internal outcomes. Each one routes to the process that answers it and the team that owns the response.

GMP Form 483 at a pharma-supply site

Routes to CAPA & Effectiveness · owned by Quality

REACH / TSCA finding on an untracked change

Routes to Regulatory Dossier · owned by Regulatory

Supplier change notification to a pharma customer

Routes to Supplier Change Notification · owned by Supplier Quality

The cost is real. It just never lands on a line you can see.

Coordination tax, per company per year

$0.2Mto$2.6M

Paid in chasing, handoffs and rework, one coordination event at a time. No budget line carries it, so nobody owns it. Modeled across 117 companies and 0.94M employees in the segment.

Coordination eventWhat’s at risk
  • Formulation / process changeECN-2210Process / Qualitycycle time; a customer or regulatory notification missed
  • Deviation → CAPA483 responseQualityweeks of cycle time; an audit finding if it ages
  • Supplier qualification & changeNew solvent supplierSupplier Qualitymaterial on hold; a spec or SDS gap
  • Process safety / MOC reviewSolvent MOCEHSa reportable incident; PSM enforcement
  • Batch record & CoA reviewFirst batch CoAQualitymaterial on hold; delayed shipment
Every instance, every team. None of it on a budget line.

Incumbents track the change log. Unifize reconstructs the decision.

Pick a change or deviation you could not replay at the last audit. We will reconstruct it live.