About Indelio
You should know who is behind the system that holds your controlled documents, your signatures, and your audit trail. So here it is, plainly.
One person builds this
Indelio is built by Alexis Sockwell, sole founder. Not a team you’ll never meet behind a “contact sales” form — one person who writes the code, answers the email, and is accountable when something is wrong. The company is Reshawn Holdings LLC, doing business as Voxelio AI, in Sarasota, Florida.
Before Indelio — and still, most weeks — I’m a physician assistant. Twenty-five years of it, twenty of those in orthopedic surgery at Kennedy White Orthopedic Center in Sarasota, and I still work as a surgical first assist in total hip and knee replacement: somewhere between five and eight hundred procedures a year.
Which means I have spent twenty-five years on the receiving end of quality systems like the one this software runs. Every implant that goes into a patient, every instrument tray, every device label I check before we open it — all of that came out of somebody’s document control, somebody’s design history file, somebody’s CAPA. I have been the last person standing between that paperwork and a patient, several hundred times a year, for twenty-five years. It is not an abstraction to me.
What I am not is a quality or regulatory professional. I have never run a QMS or sat through an FDA inspection, and I am not going to pretend otherwise on a page written for people who have. What I did instead was build this alongside them: practising medical-device quality and regulatory professionals review the modules, and validation is performed by an independent consultant who did not build the system. Where the regulations are involved I don’t guess — I ask someone whose job it is, and then I show you what they said.
Why it exists
Quality systems are priced and built for companies with a quality department. Most device and biotech companies don’t have one — they have a person, often wearing three other hats, running the whole quality system on a shared drive and a spreadsheet because the alternative costs more than their headcount and takes nine months to roll out. That team still gets inspected against the same regulations as everyone else. Indelio is built for them: the rigor of an enterprise QMS, right-sized and priced for a team too small for Veeva.
How it’s built, and who checks it
The compliance controls are enforced beneath the interface, not in it — an append-only record store and a hash-chained audit trail in the database itself, and two-component electronic signatures plus segregation of duties enforced server-side, which no one, including an administrator, can click past. That’s a deliberate choice: controls in the UI can be worked around, controls behind it can’t.
The product is shaped by practicing medical-device quality and regulatory professionals — quality managers, RA specialists, and validation consultants who use systems like this for a living and who review the modules against what the regulations actually require. They advise; they don’t sign off on their own advice being implemented correctly.
Validation is performed by an independent consultant who did not build the system — which is what your auditor wants to see, and the reason it isn’t done in-house. See the full validation posture →
What we don’t claim
The Part 11 controls are built and tested today, with an automated test suite that runs on every change. Operational Qualification evidence — that suite — comes with every plan; Installation Qualification we execute against your instance; Performance Qualification is yours to execute and sign, and we never can — a system is only “validated” once that’s signed against a named deployment, so you will not see Indelio described as pre-validated. There is no SOC 2 certification yet; that program is pursued when a customer requires it. If a feature isn’t built, it isn’t on this website.
“What if you get hit by a bus?”
Ask it — it’s the right question to ask a small vendor, and the answer shouldn’t require trusting anyone. You’re never locked in, your records are portable because the platform runs on standard PostgreSQL, nothing is ever deleted because the store is append-only, and your validation package is a set of documents in your possession that don’t stop existing if the company does. An established vendor answers this with their size; Indelio answers it with your exit. Read the full answer →