AI-augmented quality for manufacturers
QualiForge generates ISO 9001–aligned SOPs, CAPA workflows, and audit-ready documentation — then a quality consultant adapts everything to your actual operation. No per-seat licensing. No consultants you see once and never again.
The problem
Greenlight Guru starts at $25K/year. MasterControl runs $50K+. You're a $100M manufacturer — not a pharma company. You don't need a bloated QMS; you need quality docs done right.
4–6% of a manufacturing site's resources go to CAPA and deviation management. Manual processes. Spreadsheets. Outdated SOPs nobody trusts. That's time your people don't have.
ISO 9001, IATF 16949, FDA 21 CFR Part 820 — the audit trail has to be perfect. And it always turns into a six-week sprint because nothing was organized before the notice came in.
What you get
Everything a functional quality system requires — built for manufacturers who can't afford to wait six months or spend six figures.
AI drafts ISO 9001–compliant standard operating procedures from your process description. A quality consultant reviews, edits, and ensures it reflects how your operation actually runs — not a generic template.
Structured CAPA workflows with AI-assisted root cause analysis, corrective action drafts, and effectiveness verification. 5-Why, 8D, or your existing methodology — all tracked, all auditable.
Pre-audit document packages, audit trail summaries, and readiness reviews compiled before the auditor arrives. Your quality records, organized and ready — not scrambled into a binder the night before.
Results from the floor
The approach
We review existing SOPs, CAPA records, and audit history. Identify gaps and prioritize the highest-friction documentation problems.
Documents are drafted using AI trained on your industry standards (ISO 9001, IATF 16949, FDA 21 CFR Part 820). Every document is reviewed and signed off by a quality consultant.
Documents delivered in your preferred format. Ongoing updates included in the monthly retainer — when regulations change or processes shift, your docs stay current.
95% of manufacturers plan to invest in AI for quality within 5 years. Most are doing it with ChatGPT — no audit trail, no consistency, no accountability. QualiForge does it properly.
What changes
AI drafts the CAPA form, root cause analysis, and corrective actions. You review and approve. No more starting from scratch every time.
Your document package is maintained continuously, not assembled under deadline. The audit-ready folder exists before the audit notice arrives.
Processes that exist only in senior operators' heads get documented. New hires can follow the SOP without needing to ask around.
It should be something that just works — updated, tracked, and ready when you need it. That's what QualiForge delivers. Let's talk about your operation.
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