DIGIFORMRegulated
Industries.
Compliance-Driven Solutions for Life Sciences
DigiForm's regulated industries practice—delivered through our subsidiary DelRay Scientific—empowers pharmaceutical, biotechnology, and medical device organizations to transform quality and compliance from a regulatory burden into a competitive advantage.
DelRay Scientific combines deep GxP expertise with AI-powered compliance technology to help life sciences organizations modernize operations, close compliance gaps, and stay ahead of regulators.
With ComplAI, our AI-powered compliance platform, and comprehensive enablement services, we ensure your systems are audit-ready, inspection-resilient, and built for continuous improvement.
Our Commitment
We don't just provide technology—we make it work in the real world through hands-on delivery in implementation, validation, training, and ongoing support.
Comprehensive
Services
Strategy & Advisory
Building the Foundation
Build the foundation for compliant AI adoption and measurable value. Our strategic approach ensures your AI investments align with regulatory requirements and business objectives.
Deliverables
Current-state findings, prioritized roadmap, risk register, governance framework
ComplAI Implementation
Launch Quickly
Launch quickly with a fit-for-purpose configuration. Our implementation methodology ensures rapid deployment while maintaining full regulatory compliance and validation requirements.
Deliverables
Configured ComplAI environments, test evidence, release notes, go-live plan
Computer System Validation
Demonstrate Fitness for Use
Demonstrate fitness for use—clearly and defensibly. Our validation approach is risk-based, efficient, and aligned to global regulatory expectations including 21 CFR Part 11 and EU Annex 11.
Deliverables
Complete validation package aligned to regulatory expectations
Integration & Data
Complete, Consistent, Usable
Make your compliance data complete, consistent, and usable. We integrate ComplAI with your existing quality systems to create a unified compliance ecosystem.
Deliverables
Integration design specs, tested interfaces, data quality reports
Training & Change Enablement
Drive Adoption
Drive adoption with clear, role-specific enablement. We provide comprehensive training programs tailored to QA, Manufacturing, IT, and Supplier roles.
Deliverables
Training plan, materials, attendance/competency records, adoption dashboard
Managed Services
Optimized & Audit-Ready
Keep ComplAI optimized and audit-ready—every day. Our managed services ensure continuous compliance, performance optimization, and proactive support.
Deliverables
Ticket/resolution reports, release runbooks, health check findings, improvement plan
Why Partner with DelRay Scientific
As a DigiForm subsidiary, DelRay Scientific brings the innovation and digital transformation expertise of a modern technology firm with specialized focus on regulated industries. We bridge the gap between cutting-edge AI capabilities and strict regulatory requirements.
Deep GxP Expertise
Our team combines regulatory knowledge with hands-on delivery. End-to-end CSV aligned to 21 CFR Part 11 and cGMP, with audit preparation and mock audits for internal, supplier, and regulatory scenarios.
AI-Powered Compliance
ComplAI platform delivers always-on controls, auto-evidence, and audit-ready reporting. Continuous auditing capabilities with a risk-based approach to validation ensure you stay ahead of regulators.
Full-Lifecycle Support
From strategy and advisory through implementation and managed services, we provide role-based training paths for QA, Manufacturing, IT, and Suppliers, with proactive support and SLAs.
Proven Track Record
Audit-ready, inspection-resilient solutions built for continuous improvement. Real-world deployment experience across pharmaceutical, biotechnology, and medical device organizations.
Frequently Asked Questions
What is 21 CFR Part 11 compliance and why does it matter for AI systems?
21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures in life sciences. For AI systems, this means implementing controls for data integrity (ALCOA+ principles), audit trails, user authentication, validation documentation, and change control. Non-compliance can result in warning letters, consent decrees, or product recalls. DelRay Scientific ensures your AI systems meet Part 11 requirements from day one, with validation protocols, traceability matrices, and audit-ready documentation.
How long does CSV (Computer System Validation) take for an AI platform?
CSV timelines depend on system complexity and risk classification. For GAMP 5 Category 4 systems (configured products like ComplAI), expect 8-12 weeks for initial validation: requirements gathering and risk assessment (2 weeks), validation protocol development (2-3 weeks), testing execution (3-4 weeks), and documentation review (1-2 weeks). Category 5 systems (custom AI models) require 12-18 weeks due to algorithm validation and model qualification. DelRay Scientific accelerates this with pre-validated templates, automated testing frameworks, and regulatory expertise.
Can we use AI in GxP environments or is it too risky?
AI is absolutely viable in GxP environments when implemented with proper controls. The FDA, EMA, and other regulators increasingly recognize AI's value for quality control, process optimization, and decision support. The key is risk-based validation: high-risk applications (batch release decisions, clinical data analysis) require extensive validation and ongoing performance monitoring, while lower-risk uses (document classification, scheduling optimization) need lighter controls. DelRay Scientific specializes in risk-appropriate AI validation that satisfies regulators without over-engineering.
What's the difference between ComplAI and building a custom AI solution?
ComplAI is a pre-validated, configurable AI platform designed specifically for life sciences compliance workflows (document management, quality events, CAPA, training records). It's GAMP 5 Category 4, meaning faster validation (8-12 weeks vs. 6-12 months for custom builds), lower total cost of ownership (no custom code maintenance), and regulatory precedent (used across multiple FDA-inspected sites). Custom AI solutions make sense for unique scientific algorithms or proprietary processes, but for compliance workflows, ComplAI delivers 80% of the value at 20% of the cost and risk.
How do you handle AI model drift and revalidation in regulated environments?
Model drift—when AI performance degrades due to changing data patterns—is a critical GxP risk. DelRay Scientific implements continuous monitoring with statistical control limits, automated alerts for performance degradation, and predefined revalidation triggers. Our approach includes periodic performance qualification (quarterly or annual depending on risk), change control integration for model updates, and validation protocols for retraining. We also maintain validation status throughout the system lifecycle, ensuring audit readiness and regulatory compliance even as models evolve.
What happens during an FDA inspection if we're using AI systems?
FDA inspectors will review your AI systems' validation documentation, data integrity controls, and decision-making transparency. They'll ask: How was the system validated? How do you ensure data integrity (ALCOA+)? Can you explain AI-driven decisions? What's your change control process? DelRay Scientific prepares clients with mock audits, inspection-ready documentation packages (validation protocols, test scripts, traceability matrices, SOPs), and expert support during live inspections. Our clients have successfully passed FDA, EMA, and MHRA inspections with AI systems in place—we know what regulators look for and how to demonstrate compliance.