Pharmaceutical Compliance Management Platform

Optimise drug quality. Accelerate time to market.

BPR Hub automates cGMP compliance, reduces batch record documentation burdens, and keeps you always inspection-ready—so you can focus on delivering life-saving medications faster.

FDA compliance

Steer clear of FDA 483 observations

Access real-time data

Always be audit-ready

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The all-in-one platform for
Quality, Compliance, and
Governance (QCG).

30+ standards. One platform.

ISO 9001

ISO 45001:2018

ISO 14001:2015

ISO 13485

AS9100D

ISO 17025

Trusted by Leading Manufacturers Worldwide.

What makes BPR Hub different?

Unlike fragmented ERPs or manual compliance tracking, BPR Hub brings everything into one place
—simplifying compliance, reducing risks, and accelerating product releases.

Evidence collection for compliance (cGMP, FDA)
Risk assessment capabilities to prevent deviations
Integrated workflow for quality assurance & production teams
Batch traceability & product lifecycle management

Centralized Batch Records and Documentation

The Challenge

Fragmented batch records lead to 483 observations, delayed product releases, and potential recalls.

The Solution

BPR Hub keeps all batch manufacturing records (BMRs) in one place—secure, searchable, and always compliant with 21 CFR Part 11.

No more incomplete batch documentation

Automated electronic signatures and audit trails

Meet FDA data integrity ALCOA+ principles with confidence

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Multi-Regulation Pharmaceutical Compliance

The Challenge

Managing FDA & GMP across global markets is complex and costly.

The Solution

BPR Hub automates compliance alignment so you stay ahead of evolving regulations.

Automate gap analysis between FDA and international requirements

Run unlimited compliance checks to prevent warning letters and import alerts

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cGMP Quality Risk Management

The Challenge

Inadequate risk assessment leads to quality deviations, Out of Specification (OOS) results, and costly product investigations.

The Solution

BPR Hub ensures quality at every step of your pharmaceutical manufacturing processes.

Automate cGMP training management with real-time tracking of employee learning across FDA standards

Track critical quality attributes (CQAs) throughout manufacturing

Validate processes from Phase 1 to commercial production

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Every batch perfect. Every inspection passed. Every time.
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The all-in-one platform for
Quality, Compliance, and
Governance (QCG).