Full-Scenario Digital Compliance Solutions
RegPilot provides AI-driven validation and compliance solutions covering the full lifecycle for life sciences enterprises. Reshape quality management through automation technology, helping enterprises achieve dual leaps in global compliance access and operational efficiency.
Industry-Specific Solutions
Deep expertise in life sciences verticals, precisely addressing global differentiated compliance needs.
Pharmaceutical Enterprises(Pharmaceutical)
Addressing the complex production and quality management processes of modern pharmaceutical industry, providing end-to-end digital transformation solutions from R&D to commercial production, ensuring full GMP compliance.
CSV/CSA Automation
Utilizing Computer System Validation (CSV) automation engine to significantly reduce manual documentation effort.
Full-Process Electronic Data
Building complete electronic data recording systems for lifecycle management of Source Data.
GMP Compliance
Deep alignment with NMPA, FDA, and EMA GMP standards, ensuring systems remain in a controlled state.
Medical Device Enterprises(Medical Device)
Addressing Computerized System Validation (CSV) needs for medical device enterprises, providing an automated validation document generation and management platform covering the full validation lifecycle, supporting custom template upload and automatic variable filling, ensuring validation processes comply with ISO 13485, 21 CFR Part 11, and ALCOA+ data integrity requirements.
Computerized System Validation (CSV) Automation
Covering the full CSV lifecycle, enabling automatic linking and document generation of requirements → risks → tests → reports; automatically triggering incremental validation after system deployment and changes, continuously maintaining validation state, significantly reducing manual documentation effort.
Validation Template Management & Auto-Fill
Supporting user-uploaded custom Word validation templates; providing template version management and team reuse, not bound to fixed template formats, flexibly adapting to existing enterprise validation systems.
Multi-Market Compliance & Data Integrity
Deep alignment with NMPA, FDA 21 CFR Part 11, EU MDR, and ISO 13485 multi-market validation requirements, with built-in ALCOA+ data integrity assessment items, electronic signature, and audit trail specialized tests, supporting differentiated compliance configurations.
Core Capability Solutions
Leveraging powerful AI core engine to completely liberate compliance work from tedious manual labor,开启 the era of intelligent validation.
Full-Process CSV Automation
AI engine through semantic understanding of business processes, automatically parses URS requirements, dynamically generates end-to-end test scripts and logic validation chains, reducing traditional validation cycles by up to 70%.
AI-Assisted Document Generation
One-click generation of complete regulatory-compliant documentation systems, including:
Automatic Incremental Verification
24/7 non-intrusive automatic monitoring of system changes, real-time analysis of technology iteration impact on compliance status, preventing issues before they arise.
Audit Trail & Traceability
Build complete traceability matrix (RTM) from requirements (URS) to functional specification (FS), risk assessment (FRA), OQ test cases (OQ) and execution records.
Quality Risk Management
Built-in GAMP 5 and FMEA risk assessment models, AI automatically identifies quality critical points and provides control strategy recommendations.
Authoritative Compliance Assurance (Compliance)
RegPilot strictly follows standards and guidelines from major global life sciences regulatory agencies. Our platform is not just a tool, but your legal shield in the digital validation journey, ensuring absolute legitimacy of your digital assets in any jurisdiction.
Ready to Start Your Intelligent Compliance Journey?
Improve operational efficiency by 40% and reduce hidden compliance costs by 60% with the RegPilot digital compliance platform.