BIGAN — The GMP AI Companion

Built for individuals

A personal companion. Not a platform rollout.

BIGAN is a lightweight subscription you control yourself. No vendor onboarding, no procurement cycles, no Part 11 implementation — just open it and start working.

No enterprise setup

No IT integration

Works on any device

Ready in 60 seconds

Sign up & go

Subscribe in your browser, pick your role, and BIGAN is ready. No demos, no sales calls, no procurement gauntlet.

Outside regulatory scope

BIGAN doesn't store records, integrate with company systems, or act as a Part 11 tool. It's a reference companion, deliberately scoped.

Yours, not your employer's

BIGAN moves with you. Your subscription, your tool — build expertise that follows your career, not your org chart.

Twelve Knowledge Domains

The whole GMP landscape, in one place.

Most tools cover one corner of compliance. BIGAN covers all of it — so consultants, QA professionals, and operators have one trusted place to turn, no matter where the question comes from.

Quality Systems Management

Deviations & CAPA

Inspection & Audit Readiness

Validation & Qualification

QC Microbiology & Contamination Control

Analytical Assays

Process & Manufacturing

Facilities & Engineering

Information Technology

Supply Chain & Materials

Packaging, Labeling & Distribution

Operational Excellence

Practical Tools

Built for the work, not the slides.

Six cross-cutting modules turn GMP knowledge into something you can use today — drafts, checklists, audits, and references that meet you in the moment.

Risk Management Tools

Fishbone diagrams, FMEA scaffolds, and structured probes that take cause analysis from blank page to working draft.

OpEx Vision Audit

Walk a process, score the gaps, and surface improvement opportunities grounded in operational excellence principles.

Document Builder

Draft SOPs, work instructions, and job aids.

Deviation Writing Assistant

Walk through deviation events step by step — from event description and immediate actions to root cause and CAPA framing.

Regulatory Intelligence

Stay current on FDA, ICH, EU GMP, and other framework updates that touch your day-to-day.

Project Management & Analytics

Track initiatives, milestones, and trends across your areas of responsibility.

Always Evolving

A companion that grows with you.

BIGAN isn't shipped and forgotten. New tools, deeper domain coverage, and emerging regulatory updates roll out continuously — guided by what subscribers actually need. You're not buying a product. You're joining one in motion.

Live

12 Domains & 6 Tools

Full GMP coverage and core working modules.

Visual Data Review Tool

Built for QA reviewers and on-the-floor teams to spot trends, anomalies, and review-by-exception opportunities.

Expanded Regulatory Guidance Library

Deeper coverage across FDA, ICH, EU GMP, USP, PDA, and ISPE frameworks — broader, faster, more current.

Planned

Inspection Simulator

Practice mock inspections with realistic auditor scenarios.

Planned

Team workspaces

Optional collaboration features for consulting cohorts.

Frequently Asked

Questions worth asking first.

The pharma and biotech world is careful for good reason. Here are the things most people want to know before getting started.

Is BIGAN a regulated tool? Do I need to validate it?

BIGAN is intentionally scoped outside regulatory scrutiny. It doesn't store GxP records, doesn't integrate with company systems, and isn't a Part 11 tool. Every output is a reference framework that you take back to your own quality system for formal review and approval. Think of it as a personal advisor, not a controlled document repository.

What's the difference between BIGAN and a general AI like ChatGPT?

General AI tools are trained broadly and don't know GMP from GAMP. BIGAN is built specifically for pharmaceutical and biotech work, grounded in FDA, ICH, EU GMP, USP, PDA, ISPE, and ISO frameworks. It also includes purpose-built tools — Risk Management, Document Builder, OpEx Audit — that a chat interface alone can't deliver.

Do I need IT approval or a procurement process to use it?

No. BIGAN is a personal subscription. Sign up in your browser, pay yourself, and you're working in under a minute. No vendor questionnaires, no integration projects, no Part 11 assessments. It works on any device with a browser — corporate IT environments included.

Who is BIGAN for?

Anyone working in or around GMP — from new hires who need a fast on-ramp, to seasoned QA leaders, to consultants juggling unpredictable cross-domain questions. BIGAN tailors itself to your role on day one and grows more useful as your responsibilities expand.

Can I use BIGAN's outputs in regulatory submissions or formal SOPs?

BIGAN outputs are starting points and reference frameworks — not finished, approvable documents. Anything you generate must go through your own organization's quality review and approval process before being used in regulated activities. Every output carries a clear disclaimer to that effect.

How does BIGAN stay current with regulatory changes?

The Regulatory Intelligence module surfaces relevant FDA, ICH, EU GMP, and other framework updates as they happen. New tools and deeper domain coverage are added on a continuous roadmap shaped by subscriber feedback — BIGAN is designed to grow with the field, not freeze at launch.

What does it cost?

BIGAN is a personal monthly or annual subscription priced for individual professionals — not enterprise contracts. Preview cohort participants get free access during the beta period in exchange for feedback. Pricing details will be shared with the preview cohort first.

What about my data privacy?

BIGAN is designed for personal use without storing GxP records or company-confidential information. Don't paste anything into BIGAN you wouldn't be comfortable putting into any cloud-based AI tool. We treat your conversations as private to your account and never share them with employers or third parties.

The GMP companion for every question, every role.