Industries · Pharmaceuticals

One OOS result stops the batch.The release carries the reason.

Built for commercial pharma sponsors and CDMOs, where every deviation, every change, and every batch decision has to stay traceable across quality, regulatory, and operations, and survive an FDA inspection.

Built for GxP-regulated pharma teams

  • 21 CFR 210/211
  • 21 CFR Part 11
  • ICH Q10
  • EU GMP Annex 11
  • EU Annex 1

The decision lives in the thread, not the batch record.

Incumbents track deviation and document status. Unifize reconstructs the decision trace across every function a change touched: the reasoning an inspector actually asks for.

When the inspector is in the room, 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 inspection.

Quality leadership

Every release and deviation decision stays reconstructable.

See the quality solution →

Operations leadership

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

Regulatory Affairs

The submission, CMC change, and label trail stays current and traceable.

Regulatory affairs →

Compliance & Validation

Approvals are captured as Part 11 and Annex 11 e-signatures and the audit trail is the record itself.

How it stays validated ↓

Tech Transfer & NPI

Process and formulation changes move fast with their rationale sealed to the record.

See the change control solution →

Deviation, change, suppliers, training. One decision trace.

Each runs with the GxP regulations built in. Start with the one that costs you most.

Quality

From the deviation on the floor to CAPA effectiveness and QP release.

  • Deviation Management
  • CAPA & Effectiveness
  • OOS / OOT Investigation
  • Batch Record Review & Release
  • Internal Audit
See the quality solution →

Product Development

CMC and process changes classified, like the excipient change DEV-4471 exposed, with post-approval impact assessed.

  • CMC Change Control
  • Tech Transfer / Scale-up
  • Process Validation (PPQ)
See the change control solution →

Supplier Management

API, excipient and CMO changes worked across the boundary, before they reach a batch, not after.

  • Supplier Qualification
  • Supplier Change Notification (SCN)
  • Quality Agreements
See the supplier solution →

Training & Competency

Every SOP revision fans out to the roles it touches, before the effective date, including the ones a CAPA revises.

  • Training Cascades
  • Competency / Re-qualification

Built to live inside a GxP-validated environment, not one you have to re-validate.

  • Coexistence, not replacement

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

  • Part 11 and Annex 11 e-signatures

    Every approval is captured as an attributable, time-stamped electronic signature, so the decision trace is the audit trail: ALCOA+ by construction, not reconstructed after the fact.

  • Your CSV questions, answered directly

    IQ / OQ / PQ, the GAMP 5 lifecycle, audit-trail integrity, and data-integrity posture are walked through with your validation team before anything touches a GxP record.

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

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

FDA Form 483 observation issued

Routes to CAPA & Effectiveness · owned by Quality

Recall scope definition required

Routes to Recall Execution · owned by Quality / RA

Change-driven training cascade gap

Routes to Training Cascades · owned by Quality / Training

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

Coordination tax, per company per year

$1.1Mto$11.5M

Paid in chasing, handoffs and rework, one coordination event at a time. No budget line carries it, so nobody owns it. Modeled across 74 companies and 1.33M employees in the segment.

Coordination eventWhat’s at risk
  • Deviation → CAPADEV-4471Qualityweeks of cycle time; a 483 if it ages
  • CMC / process changeExcipient changeTech Ops / Qualitymonths to implement; notification exposure
  • Batch record review & releaseBatch on holdQualitydays per lot; trapped inventory
  • APR / PQR assemblyQuality / RAa fixed annual deadline that cannot slip
  • Training cascade on changeSOP revisionQuality / Trainingan open gap between effectivity and completion
Every instance, every team. None of it on a budget line.

Incumbents track batch records. Unifize reconstructs the decision.

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