PharmaDiagrams Enterprise
Everything you need for validated pharmaceutical environments. Formal approval workflows, complete audit trails, electronic signatures compliant with 21 CFR Part 11, and full IQ/OQ/PQ documentation.
Formal sign-off with defined roles
Configure multi-step approval workflows that match your SOPs. Define who authors, reviews, and approves each document. The system enforces the sequence — no shortcuts, no skipped steps.
- Configurable approval chains (Author → Review → Approve)
- Role-based access control and permissions
- Automatic notifications and reminders
- Parallel and sequential approval paths
Electronic signatures that regulators trust
Every signature captures the who, what, when, and why. Full compliance with FDA 21 CFR Part 11 and EU Annex 11 requirements for electronic records and signatures.
- Unique user identification with password authentication
- Signature meaning captured (Authored, Reviewed, Approved)
- Tamper-evident timestamps linked to each signature
- Non-repudiation — signatures cannot be copied or transferred
Electronic Signature Record
UFDF-001-R03 • Approved
Complete history of every change
Every action is logged with timestamp, user ID, and before/after values. Immutable records that cannot be edited or deleted — exactly what auditors expect.
- Automatic logging of all create, modify, and delete actions
- Before and after values for every change
- User identification tied to each action
- Exportable audit reports for regulatory submissions
IQ/OQ/PQ documentation included
Complete validation documentation package ready for your QA team. Pre-written protocols, test scripts, and summary reports — so you can validate faster.
Installation Qualification
Verify that the system is installed correctly according to specifications.
- System requirements verification
- Installation checklist
- Configuration documentation
Operational Qualification
Confirm that the system operates as intended across all functions.
- Functional test scripts
- User access control testing
- Audit trail verification
Performance Qualification
Demonstrate that the system performs reliably in your environment.
- End-to-end workflow testing
- Signature workflow validation
- Data integrity checks
Enterprise-grade security built in
Your process diagrams contain sensitive IP. We protect them with the same rigor you'd expect from any critical system.
SSO Integration
SAML 2.0 and OIDC support for seamless enterprise authentication.
Role-Based Access
Granular permissions at the organization, team, and document level.
Data Residency
Choose where your data lives — EU, US, or dedicated instance.
99.9% Uptime SLA
Guaranteed availability with proactive monitoring and support.
Ready to validate your PFD workflow?
Schedule a demo with our team. We'll walk through your requirements and show you exactly how PharmaDiagrams Enterprise fits your validation strategy.
Or email us at contact@pharmadiagrams.com