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biotech

FDA Part 11 Starts With Your Data, Not Your Paperwork

When an FDA auditor, a commercial partner's due diligence team, or your next round's investors come asking, the question is the same: can you prove your electronic records and signatures are complete, attributable, and tamper-evident? 21 CFR Part 11 and GxP data integrity rest on audit trails you can produce on demand, and HIPAA applies the moment clinical or patient data is in the mix. Amoeba Networks builds and runs the systems behind that evidence for biotech and medical device startups across the New York Metro and the Puget Sound Area.

Your research data, lab pipelines, and IP are the company. We treat them as production systems, with the controls and recovery to back that up, so a missing log entry or an unsecured file share never becomes the reason a raise stalls or an audit slips.

Disconnected Lab and Cloud Systems Don't Leave an Audit Trail

Early-stage teams stitch together instrument software, cloud storage, spreadsheets, and shared drives, and the seams are exactly where data integrity breaks. Records get edited without a trace, access is whoever had the password, and no one can reconstruct who changed what or when. That gap stays invisible until an auditor or an investor asks you to show it, and by then it's too late to build the history retroactively.

Protect: Securing Your Research and Clinical Data

Sustain: Infrastructure That Grows With the Science

Your data footprint multiplies with every assay, study, and instrument you bring online, and the integrity of that data depends on storage and recovery that keep up. We run backup and recovery built for data integrity so a corrupted dataset or a lost drive doesn't erase months of work, and we help you scale your infrastructure without adding headcount as the science moves faster than your org chart.

Protect: Ready for the Audit and the Raise

Audit readiness and raise readiness are the same work: clean records, demonstrable controls, and evidence you can hand over without scrambling. We help you reach and document compliance and cyber insurance readiness, mapping the Part 11 and HIPAA controls a regulator or a due diligence team expects to the systems that actually enforce them, so your evidence is current the day the request lands.

Walk Into the Next Audit or Raise Already Ready

The goal is simple: when the auditor, the partner, or the investor arrives, the answer is yes, and the proof is already in hand. Sense, Protect, Sustain, Evolve is how we get you there, running the systems and producing the evidence so your team stays focused on the science instead of reconstructing it. We support your team or replace it, whichever fits where you are.

Get an Audit and Raise Readiness Review

We'll walk your data integrity, Part 11 controls, and IP protection and show you exactly where the gaps are before an auditor or an investor finds them. No cost, no obligation.

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