Life Sciences Manufacturing
From medical device makers to pharma, biotech, and CMOs/CDMOs, every decision is a patient-safety decision. A system of action keeps compliance built in, systems validated, and operations audit-ready, without slowing you down.
Solutions for Every
Segment
Different regulatory paths. One platform built for compliance, visibility and margin control.
Scale Class II/III production without slowing compliance down.
Keep batch integrity high while absorbing tariff and supply cost pressure.
Prove compliance across every sponsor program, on every run.
Compliance Moves Fast. Can You?
The compliance bar has been reset. Input costs are climbing. AI has moved from experiment to imperative. You need a system of action built for a regulated environment, not adapted to fit one.
QMSR harmonizes device regulation with ISO 13485
EU AI Act now requires risk assessments for AI-enabled devices
Regulators expect connected data, not spreadsheets
Tiered pharma tariffs and a pending Section 232 device investigation
Component prices are up, with no near-term relief
Locked-in designs mean inherited cost inflation
Bolt-on AI outside validated workflows is a liability
Few manufacturers can build and govern their own agents
Compliance fears are stalling transformation few can fund anyway
Outcomes That Move Your Business
Improve Right First Time Rates
Fewer deviations. Fewer investigations. Faster release.
Manage Raw Material and API Exposure
Keep the right supply on hand without tying up working capital.
Reduce Manual Procurement Costs
Automate procure-to-pay and speed up invoice payments.
Designed For How You Actually Operate
From raw material to release, built for a regulated environment.
Built-in support for CFR Part 11, Part 820 (QMSR), and Part 210/211
Device history, design history, and complaints in QAD EQMS
Deviation tracking and CAPA closure from one source of truth
Documentation ready for internal and FDA audit review
AI risk assessments aligned to MDR and IVDR
Native support for DSCSA and Unique Device Identification
Lot and device genealogy from raw material to finished product
Quality holds linked directly to affected lots and batches
Quality holds linked directly to affected lots and batches
Mock recalls become a query, not a scramble
Deploys into your current ERP, no migration required
Models supplier risk, tariff exposure, and landed cost
Human-in-the-loop wherever the EU requires it
Automates documentation without touching validated data
Proves results before any platform commitment
Real-time visibility into days of API and component supply
Continuous monitoring of single-source supplier risk
Tariff and landed-cost exposure modeling
Alternate-supplier qualification without disrupting validation
Real-time signals in place of spreadsheets
From the Shop Floor to the Top Floor. One System of Action.
Frequently Asked Questions
Yes. QAD supports medical device manufacturers, pharmaceutical and biotech manufacturers, and CMOs and CDMOs with process maps built for FDA Title 21 CFR Part 11, Part 820 (QMSR), and Part 210/211.
No. Champion Advantage sequences modernization around your compliance calendar, not a vendor timeline, so you can modernize without triggering a full revalidation cycle.
DSCSA, Unique Device Identification, and country-specific serialization requirements are native to the platform, so you don't need a separate system to stay compliant.
Per FDA guidance, ChampionAI agents used outside of CGMP processes do not require validation, and Champions are purpose-built to operate inside the validated boundaries a regulated environment requires.
QAD EQMS centralizes device history, design history, complaints, and CAPA closure in one system, so records are traceable and retrievable when an FDA or notified-body audit happens.