Learn. Document. Comply.All in one platform.
Pharma4i is a documentation platform for engineers, validation professionals and quality staff in regulated pharmaceutical manufacturing. URS authoring is the only working module today — the rest of the platform is in development, and we say so openly.
- Built for GxP documentation
- Annex 11 and 21 CFR Part 11 aware
- Your data stays in your organisation
Platform
What Pharma4i is being built to do
Industry-Focused Courses
Training topics centred on pharmaceutical documentation and validation practice.
AI Draft Generator
Answer structured questions and receive a vendor-neutral URS draft for review.
Smart Templates
Control document structure, styling and boilerplate without changing requirement content.
Structured for Review
Requirement status, assumptions and revision history keep review decisions visible.
Track & Certify
Learning progress and completion records belong to the planned course module.
Secure & Data Protected
Organisation-level access control, and vendor specifications are never stored.
Free tool
Is your system direct impact?
Answer six plain-language questions and get a GMP impact classification you can download as a controlled one-page document. No login required.
Run the assessment- Contacts product
- Yes
- Controls a critical parameter
- Yes
- Classification
- Direct Impact
Four steps, in order
Each step locks until the previous one is complete, so a document cannot be exported around its own review.
Project setup
Record the system, equipment type, site and GxP impact. The document number and revision are fixed from the start.
Requirements input
Answer structured questions or paste a vendor specification. Anything you could not confirm is captured as an open assumption rather than quietly asserted.
Review and approve
Work through requirements by category, resolve assumptions, and see what still blocks issue.
Export
Export the URS as a plain, reviewable document with an approvals block ready for signature.
Course module
Course categories in development
The course module is not live. These are the subject areas it is being organised around — planned categories, not courses available today.
GMP & Quality Assurance
Good manufacturing practice and pharmaceutical quality systems.
Regulatory Affairs & Compliance
Regulatory expectations and how they affect documented requirements.
Validation & Qualification
DQ, FAT, SAT, IQ, OQ and PQ across the equipment lifecycle.
Pharmaceutical Manufacturing
Equipment, utilities and process systems in regulated production.
Data Integrity & ALCOA+
Attributable, legible, contemporaneous, original and accurate records.
Documentation Best Practices
Clear, testable requirements and controlled document practice.
What is real today
- URS Generator
- Live
- Word export
- Included
- Vendor specifications
- Never stored
- Courses and certificates
- Planned
See the output
Judge the document, not a promise.
Read a complete URS and the Design Qualification written against it, for the same Water for Injection storage and distribution system. Ungated: every DQ verdict traces to a requirement ID in the URS.
Read and download the sample package
USER REQUIREMENTS SPECIFICATION
Purified Water Distribution Loop
URS-EXAMPLE-001 · REVISION 1.0
DOCUMENT PURPOSE
This specification defines the user requirements for a purified water generation, storage and distribution system serving six points of use.
Start with the URS.
The working module is available now. The rest of the platform is in development and marked as such.