Audit-ready without the enterprise contract.
MasterControl is the gold standard for FDA-regulated quality management in medical devices and aerospace. If you're an FDA Class III device manufacturer, MasterControl is probably the right tool. If you're an 80-person job shop pursuing ISO 9001 because a customer asked, MasterControl is an absurd amount of software for the problem in front of you. Ignite Lean is the same audit-ready answer at one-tenth the cost.
The heavyweight champion of regulated QMS.
MasterControl has decades of FDA audit experience baked into the product. 21 CFR Part 11 e-signatures with full strict-mode compliance. Validation packs for IQ/OQ/PQ. Deep document control with full electronic signatures and complete audit trails. If your auditor works for the FDA and the product you ship can kill someone if it fails, you want MasterControl.
- 21 CFR Part 11 strict-mode e-signatures (validated)
- Deep document control — versioning, approval, distribution
- Validation packs (IQ / OQ / PQ) for regulated environments
- Decades of FDA audit history baked into the workflows
- Strongest pedigree in medical devices + life sciences
It's built for enterprises that can absorb the cost.
MasterControl's pricing isn't public, but typical SMB quotes land in the $50k-$150k/year range with a 6-month consultant-led implementation. That math doesn't work for an 80-person shop. Beyond price, the bigger issue: MasterControl is detached from your production system. CAPAs live in MasterControl. Nonconformances live in MasterControl. But the actual *defect* happened on a build that lives in your MES — and reconciling the two is a manual job.
- Pricing: $50k-$150k/yr typical contracts
- Implementation: 6 months with consultants
- Detached from production data (NCs in QMS, builds in MES)
- Over-built for ISO 9001 — designed for FDA Class II/III
- Heavy training burden on quality team to operate
Audit-ready, integrated, $49/seat.
Ignite Lean ships every ISO 9001 / AS9100 / IATF 16949 audit answer in the same platform that runs your floor. CAPA with effectiveness verification (§10.2), internal audit program (§9.2), supplier SCAR (§8.4), calibration register (§7.1.5), training matrix (§7.2), management review pack (§9.3), engineering change notice (§8.5.6), risk register with FMEA. Every NC ties to the build it came from. Every CAPA ties to the NC. Every approval is attributed and timestamped. Same data, same tablet, audit-ready.
- Every ISO 9001 / AS9100 / IATF 16949 clause has a live answer
- NCs join to build records — full traceability without reconciliation
- SHA-256 hash-chain e-signatures on WI publish (ISO 9001 / AS9100 grade)
- $49/seat/month bundled with the MES + CMMS
- Audit-day mode flips the system into read-only with print-to-PDF evidence
FDA Class II/III medical or strict pharma. Anything else, reconsider.
Pick MasterControl if: you ship FDA-regulated medical devices (Class II or III), you manufacture pharma under cGMP, or you're subject to 21 CFR Part 11 strict-mode enforcement. In those cases the validated e-signature stack alone is worth the contract. For ISO 9001 / AS9100 / IATF 16949 audit prep, you're over-buying — by a factor of ten.
- FDA Class II/III medical device manufacturing
- cGMP pharma under FDA inspection
- 21 CFR Part 11 strict-mode compliance required by contract
- A regulator has explicitly required MasterControl by name
FDA-grade QMS vs. ISO-grade integrated operations.
MasterControl: FDA-validated, decades of regulated history, enterprise price tag, separate from production. Ignite Lean: ISO 9001 / AS9100 / IATF 16949 audit-ready, baked into the production system, $49/seat, deploys in a week. If your auditor doesn't work for the FDA, the second model wins.
- MasterControl = FDA-grade QMS as a standalone enterprise product
- Ignite Lean = ISO-grade QMS as a layer of the production platform
- Tenth the cost. Tenth the implementation timeline. Same audit answer for ISO
Frequently asked questions
Is Ignite Lean a MasterControl alternative?
For SMB manufacturers, often yes. MasterControl is built for heavily regulated FDA environments and priced and implemented accordingly. If you need ISO 9001, AS9100, or IATF 16949 evidence rather than full FDA validation, this covers it at a fraction of the cost.
Where is MasterControl still the right answer?
Regulated pharmaceutical and Class III medical device work with formal computer system validation requirements and a validation budget to match.
What is the practical difference day to day?
Here the quality record is created by the build itself, so a non- conformance already knows its serial, station, operator, and work instruction revision. In a standalone QMS, someone re-enters that context.
The rest of Ignite Lean
Ready to run your line on Ignite Lean?
Free during early access — 1 manager seat included, unlimited operators.
Get early access