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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
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
ISO 17025
Trusted by Leading Manufacturers Worldwide.
Unlike fragmented ERPs or manual compliance tracking, BPR Hub brings everything into one place
—simplifying compliance, reducing risks, and accelerating product releases.
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
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
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
The all-in-one platform for
Quality, Compliance, and
Governance (QCG).