Live AI-Powered Pharma Document Management
DocSure uses AI agents to eliminate 80% of manual document management for pharmaceutical SMEs. Designed for Annex 11. 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. Designed to support Annex 11 compliance.
Continuous monitoring of your documentation status against GMP, ICH Q10, and ALCOA+ requirements. Get alerts before gaps become inspection findings — not after.
Structured workflows for initiating, evaluating, approving, and closing changes to processes, equipment, or documents. Full traceability from request to implementation with automated impact assessments and regulatory cross-references.
Capture, classify, and investigate deviations with AI-assisted root cause analysis. Automated escalation rules, deadline tracking, and direct linkage to CAPAs ensure every deviation is resolved and documented to GMP standards.
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.
Implementation
No 6-month implementations. No internal IT projects. Just a guided, validated deployment with your team.
Week 1
We audit your current document landscape, map compliance gaps against Annex 11 / GMP requirements, and define the precise configuration plan.
Weeks 2–4
AI agents are configured to your SOPs, templates, and workflows. All existing documents are migrated and indexed from your current systems.
Weeks 5–7
IQ/OQ validation support per GAMP 5. User acceptance testing with your QA team. Unlimited training sessions in English and Spanish.
Week 8+
Production deployment. Your team has the tools to support audit readiness from day one. Dedicated CSM, 24/7 system monitoring, and quarterly optimization sessions.
Use Cases
Problem
Manual SOP lifecycle: creation, review, approval, distribution, and training tracking across 200+ documents
Solution
AI-assisted SOP drafting from templates, e-signature approval routing, training acknowledgment tracking, and periodic review alerts
Result
Significant reduction in SOP lifecycle time
Problem
ICSR processing consumes 7+ days and two-thirds of PV team resources
Solution
AI-assisted intake and data pre-population for incoming safety reports, with structured workflows subject to validated processes and human oversight
Result
Reduced manual effort in case processing workflows
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
Accelerated evidence collection and inspection readiness
Problem
Change requests managed via email and spreadsheets — no visibility into status, missing impact assessments, and incomplete closure documentation
Solution
Structured change control workflows with automated impact assessment, multi-level approval routing, linked CAPA/deviation tracking, and regulatory cross-referencing
Result
Full traceability from request to closure — zero orphaned changes
Problem
Deviations logged inconsistently, root causes poorly documented, and investigations closed without proper effectiveness checks — recurring findings in GMP inspections
Solution
Standardized deviation capture with AI-assisted classification, guided root cause analysis (Ishikawa, 5 Whys), automated escalation rules, deadline alerts, and direct CAPA linkage
Result
50% fewer recurring deviations with complete investigation trails
Problem
Incomplete investigations, missed deadlines, and recurring findings in CAPA management
Solution
AI-supported structured root cause analysis by organising evidence, suggesting patterns, and tracking CAPA timelines, with final assessment under qualified human responsibility. Automated deadline tracking, effectiveness check scheduling, and trend analysis across deviations
Result
Improved CAPA closure times with structured root cause documentation
Regulatory Compliance
Every feature in DocSure is designed to support compliance with pharmaceutical regulatory requirements from day one. No add-ons. No workarounds.
DocSure supports validation per GAMP 5 methodology. IQ/OQ documentation and validation support provided with every deployment. Capabilities depend on configuration, validation scope, and intended use within GxP processes.
Why Switch
From spreadsheets and shared drives to the most capable enterprise QMS — DocSure delivers enterprise-grade compliance at a fraction of the cost and complexity.
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 traditional enterprise QMS pricing. Pay per AI agent — start with one and scale as you grow. No per-user fees.
No 6-month implementation projects. DocSure can deploy within weeks depending on scope and validation requirements, with guided onboarding, data migration support, and unlimited training in English and Spanish.
Founding Clients Program
We are currently onboarding our founding clients. Early access includes direct access to our product team, priority configuration support, and founding pricing locked for life.
From signed contract to production-ready system. Configuration, data migration, and validation support included. No internal IT required.
The first 5 clients get our founding rate. Price never increases as long as you stay subscribed. You shape the product roadmap directly with our team.
ISO 27001 certified. ENS and NIS2 aligned. EU data residency. DocSure inherits Delbion's enterprise-grade security framework from day one.
3 of 5 spots remaining
The Team
The same team that secures critical infrastructure now applies that rigour to pharmaceutical document management.
"We've spent years securing critical infrastructure. Now we apply that same security rigour to AI-powered pharmaceutical document management."
"We design agents that act with surgical precision: every decision is anchored to real data and every action is fully traceable — essential for GMP compliance."
"Our RAG models are deterministic. If the AI can't find the exact answer in your SOPs or regulatory protocols, it doesn't invent. It only cites auditable truths."
"We design the architecture assuming the highest regulatory risk level. Supporting Annex 11, GDPR and GMP requirements is not optional — it's our standard from the first line of code."
"Taking AI into the pharmaceutical market requires more than technology: it requires trust, credibility and a strategy that resonates with QA and Regulatory decision-makers."
"Delbion's technology understands the operational reality of pharmaceutical environments. Agents assist with precision, but the final clinical and regulatory judgement always belongs to the specialist."
FAQ
DocSure includes technical and procedural capabilities designed to support compliance with 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 data integrity controls aligned with ALCOA+ principles. Full compliance depends on customer validation, configuration, and procedural controls. Validation support documentation is provided following a GAMP 5 risk-based approach, including risk assessment support, traceability, IQ/OQ, and supporting materials for customer acceptance testing.
Typical technical deployment may begin within 2 weeks for standard configurations. Overall implementation timelines — including validation, migration, and customer acceptance — depend on scope, integrations, and GxP requirements. We offer a 1-week Discovery Assessment to define precise scope before you commit.
Integration capabilities are available via REST APIs and connectors for common pharmaceutical systems including SAP, Oracle, LabWare LIMS, and major ERP platforms. Each integration is assessed during implementation to define validation scope, data flows, and interface controls.
DocSure's AI agents are configured using controlled templates, workflows, and regulated document structures, and are designed to support — not replace — qualified user judgment. They can draft SOP sections, assist in identifying document sections potentially impacted by regulatory updates, automate document routing and approval workflows, flag compliance gaps, and generate draft reports and structured outputs that support audit readiness. 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, quarterly review sessions to optimize your workflows, support for periodic reviews and change impact assessments, and retraining after major releases. 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, designed to support GDPR-compliant deployment with data processing controls subject to customer-specific implementation and governance. All environments feature end-to-end encryption, SOC 2-aligned 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.
Transparent Pricing
Each AI agent is configured by our team for your specific workflows. Compliance dashboard included with every plan.
Automate your first workflow — SOPs, Batch Records, or Deviations.
Cover your core pharma workflows — SOPs, Pharmacovigilance, and CAPA.
Custom setup & volume pricing
Full automation for multi-site operations with maximum volume savings.
Every agent is configured, validated, and deployed by our team. IQ/OQ documentation and validation support provided. Pricing varies depending on configuration, number of users, and validation scope. Dashboard access included at no extra cost.
Get Started
Request a personalized demo and see how DocSure can transform your document management.
