Ensure pharmaceutical quality. Accelerate compliance.
Intellect’s AI-powered QMS helps pharmaceutical manufacturers streamline GMP processes, reduce regulatory risk, and deliver safe, high-quality products to global markets faster.
Smarter AI-powered quality for safer pharmaceuticals
- Combine GMP-compliant QMS functionality with AI intelligence to accelerate time-to-market, minimize deviations, and maintain global regulatory compliance.
- Whether you're managing batch records, deviations, or CAPAs, Intellect’s AI-powered platform brings together quality, documentation, and decision-making in one place.
- Act instantly—on the floor, in the lab, or remotely—with secure access across desktop and mobile devices.
- Accelerated Regulatory Readiness
Be audit-ready for FDA 21 CFR 210 & 211 Part 11, EU GMP Annex 11, ICH Q10, and other pharma standards with automated documentation, validation support, and traceable workflows.
- Automated Document Control and Batch Record Management
Digitize SOPs, control versions, and manage electronic batch records (eBRs) with integrated e-signatures. Ensure production and QA teams are always aligned with the latest approved procedures.
- Closed-Loop CAPA and Deviation Tracking
Link deviations, complaints, and CAPAs into one traceable system. AI highlights recurring issues, recommends root causes, and shortens resolution cycles.
- Real-Time Quality Intelligence & Dashboards
Get instant visibility into quality metrics like batch release status, audit findings, CAPA aging, and training compliance with real-time dashboards. Supports data-driven decisions and continuous improvement.
Take the guesswork out of pharma quality and compliance
Stay ahead of audits and inspections
- Reduce audit preparation by up to 50% with real-time access to SOPs, training logs, CAPAs, and validation data.
- Use AI to quickly generate audit responses, summarize deviation histories, or identify documentation gaps before inspectors do.
Prevent deviations before they delay delivery
- Proactively monitor quality trends across facilities and products.
- AI detects early warning signals in deviation reports, complaint logs, or change controls, helping your team take corrective action before production is impacted.
Scale with every drug launch and site expansion
From clinical-stage startups to global pharma enterprises, Intellect grows with your needs.
Easily configure modules for:
- Document Control & Training
- Deviation & CAPA Management
- eBRs & Batch Release
- Change Control
- Equipment & Facility Validation
- Risk & Audit Management
Save time. Reduce errors. Accelerate product release.
AI streamlines daily tasks:
- Summarize batch deviations
- Generate CAPA or change control reports
- Translate SOPs into global languages
- Review training compliance across departments
Let your quality and compliance teams focus on patient safety—not paperwork.
Confident compliance at every lifecycle stage
Be inspection-ready, always. Intellect's AI-powered QMS ensures compliance across product development, manufacturing, and distribution.
Maintain control with:
- Automated audit trails
- Real-time validation support
- Linked change history and training records
- Full traceability for every decision
Stay prepared for FDA, EMA, MHRA, and other global regulators—no stress, no surprises.
Stay ahead of audits and inspections
- Reduce audit preparation by up to 50% with real-time access to SOPs, training logs, CAPAs, and validation data.
- Use AI to quickly generate audit responses, summarize deviation histories, or identify documentation gaps before inspectors do.
Prevent deviations before they delay delivery
- Proactively monitor quality trends across facilities and products.
- AI detects early warning signals in deviation reports, complaint logs, or change controls, helping your team take corrective action before production is impacted.
Scale with every drug launch and site expansion
From clinical-stage startups to global pharma enterprises, Intellect grows with your needs.
Easily configure modules for:
- Document Control & Training
- Deviation & CAPA Management
- eBRs & Batch Release
- Change Control
- Equipment & Facility Validation
- Risk & Audit Management
Save time. Reduce errors. Accelerate product release.
AI streamlines daily tasks:
- Summarize batch deviations
- Generate CAPA or change control reports
- Translate SOPs into global languages
- Review training compliance across departments
Let your quality and compliance teams focus on patient safety—not paperwork.
Confident compliance at every lifecycle stage
Be inspection-ready, always. Intellect's AI-powered QMS ensures compliance across product development, manufacturing, and distribution.
Maintain control with:
- Automated audit trails
- Real-time validation support
- Linked change history and training records
- Full traceability for every decision
Stay prepared for FDA, EMA, MHRA, and other global regulators—no stress, no surprises.
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.
