Accelerate biotech innovation. Ensure quality from lab to market.
Intellect’s AI-powered QMS helps biotechnology teams automate compliance, manage complex quality workflows, and drive faster, safer product development.
AI Intelligence quality for complex biotech pipelines.
- Meet the speed of science with a QMS built for dynamic biotech environments.
- Intellect’s AI-powered platform helps you stay compliant, manage documentation, and accelerate time-to-clinic across cell therapy, gene editing, biologics, and diagnostics.
- Unify quality across R&D, production, and external partners. Take real-time action on any device—whether you're in the lab, at a partner site, or in a regulatory review.
- End-to-End GxP Compliance
Support GxP (GLP, GMP, GCP) processes with AI-augmented traceability, document control, and electronic audit trails—fully aligned with FDA, EMA, and ICH guidelines.
- Intelligent CAPA and Risk Management
Reduce time-to-resolution with AI-assisted root cause analysis, issue trending, and linked deviation-CAPA workflows—all in one traceable system.
- Faster Approvals, Fewer Errors
Accelerate IND, BLA, or biosafety filings by reducing manual review time and automating SOP and protocol versioning, training validation, and approval processes.
- Secure, Private, and Scalable
Intellect’s closed-loop AI ensures that your proprietary research and quality data is fully encrypted and never shared or used externally.
Put biotech quality and compliance on autopilot
Built for fast-moving biotech environments
- Stay ahead of change. Intellect QMS AI tracks quality documentation, change history, and regulatory submissions across every stage of biotech development, from early research to tech transfer.
- Leverage AI to summarize deviations and flag inconsistencies - before audits happen.
Enable smarter science with AI-driven insights
- Leverage AI to analyze quality trends across multiple trials or manufacturing lots.
- Predict issues, close feedback loops, and get recommendations that strengthen both compliance and product performance.
Streamline documentation and SOP workflows
Maintain always-inspection-ready records. Intellect automates version control, e-signatures, and training validation across your SOPs, protocols, and batch records—ensuring compliance with FDA 21 CFR Part 11 and EU Annex 11.
Scale across teams, partners, and regions
Run a single lab or manage global sites. Intellect QMS AI adapts to your structure and connects internal teams and CDMOs in one system to unify quality management without spreadsheets or silos.
Audit-ready every day—with less work
Get instant answers during inspections and audits. Ask Intellect QMS AI to:
- Draft a deviation summary
- Translate a protocol
- Generate a training report
- Compare SOP versions
Let your team focus on science—not documentation hunts.
Built for fast-moving biotech environments
- Stay ahead of change. Intellect QMS AI tracks quality documentation, change history, and regulatory submissions across every stage of biotech development, from early research to tech transfer.
- Leverage AI to summarize deviations and flag inconsistencies - before audits happen.
Enable smarter science with AI-driven insights
- Leverage AI to analyze quality trends across multiple trials or manufacturing lots.
- Predict issues, close feedback loops, and get recommendations that strengthen both compliance and product performance.
Streamline documentation and SOP workflows
Maintain always-inspection-ready records. Intellect automates version control, e-signatures, and training validation across your SOPs, protocols, and batch records—ensuring compliance with FDA 21 CFR Part 11 and EU Annex 11.
Scale across teams, partners, and regions
Run a single lab or manage global sites. Intellect QMS AI adapts to your structure and connects internal teams and CDMOs in one system to unify quality management without spreadsheets or silos.
Audit-ready every day—with less work
Get instant answers during inspections and audits. Ask Intellect QMS AI to:
- Draft a deviation summary
- Translate a protocol
- Generate a training report
- Compare SOP versions
Let your team focus on science—not documentation hunts.
Our customers are our best advocates.
We needed software that could provide a strong foundation for QMS but could also be adapted quickly and easily to meet our unique needs. Intellect provided the perfect blend of what we were looking for.
By reducing manual processes with Intellect, you can anticipate reduced cycle times, fewer errors, and an overall leaner & more efficient company.
With the help of Intellect, we have been able to successfully automate our document control and supply chain processes, which has enabled us to strengthen quality and compliance.
When I was at my previous company as a quality manager using MasterControl, I was working 60 hours per week just on admin tasks. With Intellect, I spend only 10 to 15% of my time on admin work, which translates to about 6-7 hours per week. This massive reduction allows me to focus on more valuable tasks and even have my weekends back.
