AI-Powered Pharma Document Management
DocSure uses AI agents to eliminate 80% of manual document management for pharmaceutical SMEs. Annex 11 compliant. GMP-ready. Built for European regulators.
The Challenge
Pharmaceutical SMEs manage thousands of SOPs, batch records, CAPA reports, and regulatory submissions — all under the same GMP scrutiny as the largest multinationals. Documentation deficiencies are the #2 finding in European GMP inspections. The cost of non-compliance: up to €1,000,000 in fines, loss of your GMP certificate, or production shutdown.
The Platform
AI agents automatically classify, version, route, and archive your SOPs, batch records, and quality documents. Full audit trail and electronic signatures built in. Always Annex 11 compliant.
Continuous monitoring of your documentation status against GMP, ICH Q10, and ALCOA+ requirements. Get alerts before gaps become inspection findings — not after.
From pharmacovigilance case processing to CTD module assembly, DocSure's AI agents reduce preparation time by up to 55%. What took weeks now takes days.
DocSure doesn't replace your team — it gives them superpowers. Your QA and Regulatory professionals focus on decisions. The AI handles the manual work.
Use Cases
Problem
Manual SOP lifecycle: creation, review, approval, distribution, and training tracking across 200+ documents
Solution
AI agent that drafts SOPs from templates, routes for e-signature approval, tracks training acknowledgment, and flags documents due for periodic review
Result
75% reduction in SOP lifecycle time
Problem
ICSR processing consumes 7+ days and two-thirds of PV team resources
Solution
AI agent that triages incoming safety reports, pre-populates case forms, and flags signals requiring human review
Result
85% reduction in case processing time
Problem
Scrambling to locate evidence and compile documentation before AEMPS or notified body inspections
Solution
Continuous readiness dashboard with automated evidence collection, gap analysis, and mock-audit reports
Result
Audit-ready in hours, not weeks
Problem
Incomplete investigations, missed deadlines, and recurring findings in CAPA management
Solution
AI-guided root cause analysis, automated deadline tracking, effectiveness check scheduling, and trend analysis across deviations
Result
60% faster CAPA closure with better root cause documentation
Regulatory Compliance
Every feature in DocSure is designed to meet the documentation requirements of pharmaceutical regulators from day one. No add-ons. No workarounds.
DocSure supports validation per GAMP 5 methodology. IQ/OQ documentation included with every deployment.
Measurable Results
"Pharmaceutical companies using AI agents report savings of €40,000–€120,000 per FTE eliminated from manual document tasks."
— Industry benchmark data (McKinsey, Genpact)
Why DocSure
Unlike legacy QMS with bolted-on AI features, DocSure was built from the ground up with AI agents at its core. Every workflow is intelligent by default.
Designed for EMA, AEMPS, and EU GMP requirements. Not a US-centric platform adapted for Europe — built for European pharmaceutical companies from day one.
Enterprise-grade compliance at a fraction of Veeva or MasterControl pricing. Starting from €500/month — accessible for companies of 50 to 500 employees.
No 6-month implementation projects. DocSure deploys in 4-8 weeks with guided onboarding, data migration support, and unlimited training in English and Spanish.
FAQ
DocSure implements all technical controls required by Annex 11 and 21 CFR Part 11: complete audit trails for every document action, electronic signatures with dual authentication, role-based access controls, automated backup and recovery, and full data integrity per ALCOA+ principles. We provide validation documentation (IQ/OQ) following GAMP 5 methodology.
Typical deployment takes 4-8 weeks from kickoff to production. This includes system configuration, data migration from your existing document repositories, user training, and validation activities. We offer a 1-week Discovery Assessment to define precise scope before you commit.
Yes. DocSure provides REST APIs and pre-built connectors for common pharmaceutical systems including SAP, Oracle, LabWare LIMS, and major ERP platforms. We also support integration with legacy systems via custom connectors developed during the implementation phase.
DocSure's AI agents are trained on pharmaceutical documentation standards and your company's specific templates and style guides. They can draft SOP sections, suggest revisions based on regulatory updates, automate document routing and approval workflows, flag compliance gaps, and generate audit-ready reports. All AI outputs require human review and approval — the system augments your team, never replaces their judgment.
Every DocSure plan includes unlimited user training (live sessions and self-paced materials), dedicated onboarding specialist for the first 90 days, technical support with SLA, system monitoring 24/7, and quarterly review sessions to optimize your workflows. Support is available in English and Spanish.
DocSure is backed by Delbion, an ISO 27001 certified cybersecurity firm. Your data is hosted in EU data centers (GDPR compliant) with end-to-end encryption, SOC 2 controls, and optional on-premise deployment for organizations that require full data sovereignty. We perform penetration testing before every major release.
Yes. We offer a 4-week Proof of Concept that includes assessment, system configuration, and a functional prototype with your real data. This lets you validate tangible results before committing to a full deployment. The POC investment is credited toward your subscription.
Get Started
Request a personalized demo and see how DocSure can transform your document management in under 8 weeks.
