Here's a question nobody asks during the eQMS sales demo, What happens when you want to leave? Not because you're planning to leave. But because the answer tells you everything about the power dynamic you're entering. And in the medical device QMS market, that power dynamic is almost always tilted against you.
The Trap
The incumbent QMS vendors — Greenlight Guru, MasterControl, Ketryx, and others — all share a common architectural decision, whether they admit it or not: your quality data lives inside their proprietary system. Your SOPs, your design inputs, your risk analyses, your verification protocols, your entire Design History File — all of it is stored in a format that only their platform can fully read, render, and export.
This creates a dependency that compounds over time. On day one, you have a few documents and some templates. By year two, you have hundreds of controlled documents, approval histories, traceability links, training records, and audit trails woven throughout the system. The deeper you go, the harder it gets to leave.
And the vendors know this. It's why Greenlight Guru locks customers into multi-year contracts. It's why MasterControl's implementation takes months. It's why none of them offer a structured, machine-readable export of your complete QMS data. They'll give you a PDF dump if you're lucky — a stack of static snapshots stripped of all the relational structure that made the system useful in the first place.
You're not a customer. You're a hostage who pays annually.
What Lock-In Actually Costs You
The sticker price of an eQMS is already painful. Greenlight Guru runs $25K–$35K per year for a small startup with a handful of seats, scaling up significantly as your team grows. MasterControl is even more expensive and geared toward enterprise. Ketryx is newer and more developer-friendly, but still operates as a proprietary orchestration layer on top of your tools.
But the sticker price isn't the real cost. The real cost is what you pay when you want to change.
Want to switch vendors? You're looking at a months-long migration project where someone manually re-enters documents into the new system, re-establishes approval chains, and re-builds traceability links that existed as proprietary database records in the old system. You'll spend more migrating out than you spent setting up in the first place.
Want to negotiate a renewal? The vendor knows your switching cost is astronomical. Your leverage is zero. Prices go up. They always go up.
Want to get acquired? The acquirer now has to evaluate your QMS as a black box inside a vendor's platform, with no clean way to merge it with their own quality system. Your compliance infrastructure — supposedly an asset — becomes a liability.
Lightworks Is Different by Architecture
Lightworks doesn't just claim to be open. It's architecturally incapable of locking you in.
Your quality documents are Markdown files. Your document properties are YAML frontmatter. Your folder structure is your document hierarchy. Your approval history is your Git commit log. Your e-signatures are MFA-verified merge approvals. Your traceability links are relationship properties between files.
All of it lives in a GitHub repository that you own.
If you stop paying for Lightworks tomorrow, nothing happens to your data. It's still sitting in your repo, fully readable, fully structured, fully yours. You could open every document in VS Code, render it in any Markdown viewer, or build your own tooling on top of it. The files don't change. The Git history doesn't disappear. Your entire QMS audit trail remains intact and accessible — without Lightworks, without any vendor, forever.
This isn't a feature we added. It's a consequence of building on open standards instead of a proprietary database.
The Portability Test
Here's a simple test you can apply to any QMS vendor: If I cancel my subscription today, what do I walk away with?
Greenlight Guru: You can export PDFs of your documents. The relational data — traceability links, approval workflows, design control connections — stays locked in their system. Multi-year contracts mean you might keep paying long after you've decided to leave.
MasterControl: Enterprise-grade lock-in. Months of implementation to get in, months of migration to get out. Your data lives in their proprietary database and their proprietary document format. Good luck extracting it in any structured way.
Ketryx: More modern than the others, and credit to them for integrating with Jira and GitHub rather than replacing them. But Ketryx itself is a proprietary orchestration layer. The compliance metadata, enforcement rules, and traceability matrix it generates live inside Ketryx. Pull the plug and you lose the compliance layer — the part that actually matters for your QMS.
Lightworks: You walk away with a GitHub repository containing every document, every version, every approval, every traceability link, in standard open formats (Markdown, YAML, Git). No export needed. It's already yours.
Open Standards Aren't a Compromise
Some vendors will argue that proprietary systems are necessary for compliance. That you need a purpose-built database to maintain the integrity of quality records. That open formats can't provide the audit trail and access controls that the FDA requires.
This is nonsense. Git provides a more robust audit trail than any proprietary database. Every change is cryptographically hashed. Every commit is immutable once pushed. The full history is distributed across multiple machines. There's no admin who can silently modify records. There's no database migration that could corrupt your data. The integrity guarantees of Git exceed what any SaaS eQMS can offer, because they're enforced by mathematics rather than by vendor promises.
GitHub provides access controls, branch protection rules, and audit logs that map directly to FDA 21 CFR Part 11 requirements. Lightworks wraps these capabilities in a compliance layer that adds e-signatures, traceability automation, and the editing experience you need. But the foundation is open, standard, and yours.
The Real Question
Every QMS vendor will tell you they're purpose-built for medical devices. They'll show you templates and traceability matrices and e-signature workflows. And many of them genuinely deliver on those features.
But only one architecture gives you a real answer to "what happens when I want to leave?" — and it's the architecture where your data was never locked up in the first place.
Your quality system is the backbone of your regulatory strategy. It's the foundation for your FDA submission. It's the artifact that auditors evaluate when they walk through your door. It's too important to store inside someone else's proprietary database behind a multi-year contract with no structured export.
Your QMS should belong to you. With Lightworks, it does.
Lightworks is a Git-native Quality Management System for AI medical device companies. Write your quality docs in Markdown. Store them in GitHub. Let Lightworks handle the compliance.