Partner Program
When your client is asked "who authorized this decision and why" — can they answer?
If they can't, you're the one explaining it. ComplianceWorxs generates the Inspection Response Record that answers that question — from their existing documentation. You stop absorbing their exposure. They stop failing inspections.
This is not a referral program. It is the Inspection Response System for your practice.
The Partner Program in 60 Seconds
Three things you need to know.
01
The Gap
Your client can produce the batch record, the CAPA, the design history file. They cannot produce the record of who authorized the decision behind it, on what evidence, against which standard. That gap is what 483s are written about.
02
The Record
ComplianceWorxs generates the Inspection Response Record from your client's existing documentation. Inspection-ready. Same session. You stop reconstructing decisions. You deliver them documented.
03
The Revenue
25% on every IRR ($297) and every month of membership ($999–$5,000+/mo) your client uses, for 12 months. One introduction. Up to $15,000+ from an enterprise client.
Markets We Serve
FDA-regulated industries. One inspection question.
The authorization question an inspector asks is the same across every FDA-regulated industry — pharmaceuticals, biologics, medical devices, and food manufacturing. Only the vocabulary and evidence framework change. ComplianceWorxs generates the Inspection Response Record natively in each — so partners deploy industry-specific tools without translation.
Life Sciences
Pharmaceutical & Biologic
Regulatory frame: 21 CFR 211 · ICH Q7/Q9/Q10 · cGMP
Decisions served: Batch release · CAPA closure · deviation disposition · change control · OOS investigation closure · validation conclusions
Life Sciences
Medical Device
Regulatory frame: 21 CFR 820 · ISO 13485 · ISO 14971 · EU MDR
Decisions served: Design change authorization · nonconformance disposition (MRB) · risk acceptability justification · complaint and MDR decisions · supplier qualification exception
Food & Beverage
FSMA-Regulated Food
Regulatory frame: 21 CFR 117 (FSMA PCHF) · HACCP · Codex
Decisions served: Finished product release · CCP deviation handling · raw material acceptance · supplier verification · recall initiation
Cosmetics under MoCRA is on the roadmap — industry-native tooling in development. Apply and note your market; we'll activate when MoCRA-native tools go live.
See how partners deploy this.
Two deployment modes. One outcome: a defensible record exists. Three minutes to read.
See how it works →