GxP Compliant
for Pharma and Biotech
Quality and Manufacturing

In the US alone $50 billion is wasted by pharma manufacturers each year* and 70% of manufacturing data is never used**

*W. Nicholson Price II, “Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing,” 55 B.C.L. Rev. 491. **Gartner, “Cool Vendors in Manufacturing Operations, 2015” by Rick Franzosa, Simon F Jacobson, April 29, 2015.

What is


Bigfinite is a SaaS platform that uses IoT, big data, AI and cloud technologies to provide solutions for manufacturing pharma that today can not be solved with the current solutions.

Our platform allows users to discover new ways to optimize processes, reduce manufacturing quality issues and enhance regulatory compliance, leading to an ROI within 6 months.


Bigfinite does not require new hardware, software, or infrastructure. Start capturing data with a simple three-step system setup, customize how your data is incorporated into a regulatory-compliant repository, and access it through the web at any time.


Bigfinite has been designed to meet Pharma and Biotech industry information management regulatory requirements so your company can enhance compliance while achieving new economic efficiencies.


The platform is designed to adapt to different manufacturing processes with varying roles, targets and scopes. When AI and advanced statistics are applied to parallel activities, powerful insights arise through smart data aggregation.


Technology Partner

Amazon AWS Partnership
AWS life Science and Engineering team collaboration

Regulatory & Compliance

  • 21 CFR Part 11 Compliant
  • GAMP5 Framework
  • ISO 9001
  • ISO 27001
  • Data Integrity
  • GxP Environment
  • Regulated Data Lake
  • Security & Encryption