GMP / PharmaPharmaceutical manufacturing· 2026

Pharmaceutical GMP

One GMP operating system. From receipt to release.

A populated pharmaceutical GMP implementation connecting documents, materials, production, quality, and audit evidence in one role-aware operating model.

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Type

GMP / Pharma

Our role

GMP platform implementation, configuration, and operational enablement

Industry

Pharmaceutical manufacturing

The challenge

A pharmaceutical manufacturer needed more than digitized forms. Documents, materials, production, quality, and inspection evidence had to stay connected across hand-offs—without drifting across files, email, and paper.

What we delivered

DotCreative implemented one connected GMP operating system spanning source → receive → control → make → release → improve, with horizontal controls for documents, workflow, approvals, roles, training, and an immutable audit trail.

How the system works

A walkthrough of the operating model—from daily work to controls that keep the business governed.

A digital thread across the lifecycle

Every stage—from supplier orders and goods receipt through quarantine, BMR/BPR execution, release gates, and CAPA—shares the same controlled backbone.

Source: requisitions, supplier orders, purchase orders
Receive & control: batch identity, quarantine, QC worksheets
Make & release: BOM, BMR/BPR, approval gates, archive
Improve: deviation, CAPA, change, complaint, recall, OOS/OOT

Management visibility

A single cockpit surfaces training, documents, deviations, CAPA, complaints, batches, QC, and procurement signals so risks and workload stay visible.

Pending and overdue queues as early warning
Cross-function indicators in one view
27 defined roles for accountability and access

Controlled knowledge & materials

SOPs, specifications, SAPs, BMRs, and BPRs become governed records. Materials keep batch, expiry, status, and location context from receipt through quarantine.

Revision, status, and department context on documents
Training linked to controlled knowledge
Warehouse/bin accountability and controlled next actions

Digital batch execution & quality

Planning, batch issuance, approved templates, dispensing, manufacturing tables, and QC gates run as governed execution—backed by structured QA/QC modules.

54-table BMR workspace covering pre-manufacturing to sign-offs
20+ configured workflows across manufacturing and quality
Deviation, CAPA, change, complaint, recall, and OOS/OOT modules

Evidence & point-of-work enablement

Critical changes leave a reconstructable trail—who, when, what changed, before/after—while SOP-context assistance and material QR scanning support work where it happens.

12,000+ recorded audit events
SOP-context assistant against departmental baselines
Material QR scan from physical label to digital context

Core modules

The building blocks operators use day to day.

Controlled documents

Governed SOPs, specs, BMRs/BPRs with revision and lifecycle status.

Materials & quarantine

Batch identity, expiry, storage location, and status-controlled movement.

Production / BMR

Template-driven batch execution with QC gates and archive discipline.

Digital quality system

Deviation, CAPA, change, complaints, recalls, and OOS/OOT in one backbone.

Workflow engine

Repeatable multi-step processes owned by department and role.

Audit trail

Actor, timestamp, entity, action, and before/after values for review readiness.

Results at a glance

Point-in-time signals from the live or populated environment—not marketing estimates.

Approved batches

Approved QC runs

BMR records

460

Active items

Approvals visible

12.4K

Audit events

Capabilities & stack

Custom GMP platformRole-based accessWorkflow orchestrationImmutable audit loggingQR material traceability

Ready for your own operating system?

Building a GMP operating system for manufacturing, distribution, or quality operations? Start with the control gap that matters most.

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