DocSentry is a sealed pharmaceutical intelligence appliance. It reads your SOPs, audits your protocols against decades of FDA enforcement patterns, and drafts your remediation documents — without ever touching the internet.
Senior pharma SMEs are scarce, expensive, and human. They can't read every CFR, every Annex, and every warning letter ever published. DocSentry can.
Staff hours typically consumed responding to a single Form 483 observation.
Pharma SOPs survive an FDA inspection without an observation that traces back to a documentation gap.
Humans alive today have read every CFR, every Annex, and every published warning letter.
DocSentry doesn't replace your SME. It removes the parts of their job that should never have required a person — cross-checking SOPs against the regulations, scanning for the patterns inspectors actually cite, and rewriting language that won't survive an audit.
DocSentry ships as a sealed appliance. From the moment it arrives at your site, every byte stays behind your firewall.
DocSentry ships preconfigured. You plug it into power, and that's the entire installation. No internet connection. No telemetry. No phone-home. The hardware lives behind your firewall, on your premises, under your physical control.
SOPs, validation master plans, protocols, deviation reports, and your reference library are loaded once and indexed locally. Each engagement is single-tenant — DocSentry only sees one client's documents at a time, in encrypted storage that is verifiably wiped at engagement end.
DocSentry compares the document under review against your own SOPs, the regulations you operate under, and thousands of real FDA enforcement records — Form 483s and warning letters drawn directly from the public record. It surfaces gaps that match what inspectors actually cite, not generic checklists.
Where DocSentry identifies a gap, it writes the fix — in native Microsoft Word, using your house formatting, ready for QA review. Revised SOPs, deviation reports, CAPA records, validation protocols. The appliance does the writing. Your team reviews, signs, and owns the result.
Each capability runs as a discrete check. Together they form a complete documentation review of every protocol, SOP, and deviation report in your library.
Every "shall" statement in your authoring SOP, checked against the deliverable. No requirement is allowed to slip through unverified.
A 47-page IQ protocol audited against its governing SOP in under ten minutes — every requirement traced, every gap flagged.
Flags content matching real enforcement citations across thousands of historical Form 483s and warning letters.
Catches the exact language patterns that triggered an observation at a peer site last quarter — before they show up at yours.
Verifies parent-child traceability across master plans, URS, FRS, and execution protocols. Surfaces orphaned requirements.
A user requirement defined in the URS that never made it into a single test case — found before the auditor finds it.
Confirms every referenced document exists, is the current revision, and is approved. Stale references can't survive.
No more "Per SOP-2020-014 Rev. 2" when Rev. 2 was retired in 2023 — caught instantly across the entire QMS.
Finds where a document contradicts itself — mismatched acceptance criteria, conflicting test methods, drifting terminology.
The kind of mid-document drift that happens when an engineer writes a protocol over three interrupted weeks — caught and flagged.
When a gap is found, DocSentry writes the fix — in native Word, with your formatting, ready for review.
A deviation report generated from the source data and the SOP it violated, in five minutes. Your QA reviews and signs.
Every cloud-based AI tool on the market begins with a fundamental compromise: your documents leave your premises. Your SOPs, your formulations, your investigation reports — all of it lands on a third party's hardware before anything useful comes back.
DocSentry was built on the opposite assumption. The appliance ships sealed. It does not require a network connection to operate. There is no cloud component, no telemetry stream, no model "calling home" for updates. Your validation library never leaves the room it lives in.
This is not a marketing posture. It's the only way a regulated pharmaceutical company should be running document intelligence over its QMS.
DocSentry Ops extends the same air-gapped appliance into capital project execution. It maintains continuous context across months of project lifecycle — tracking every dependency, every decision, every open question from every meeting. It never loses a detail. It never leaves the project.
Every system, every transition: Received → MC → FC → Commissioned → IQ/OQ/PQ. Prerequisites enforced as first-class knowledge. Ask it "What's blocking PQ on the autoclave?" and get a real answer.
Feed it meeting minutes, walkthrough notes, vendor emails. It extracts action items, flags schedule risks, and propagates dependency impacts the moment they're spoken — not two weeks later when someone checks the minutes.
This is not a chatbot that forgets. DocSentry Ops maintains structured project state across weeks and months — every system, every prerequisite, every open question from every meeting, always current.
Asks the next logical question after every status update. You say "autoclave is mechanically complete" — it asks whether the boiler inspection is scheduled and the pressure vessel permit is obtained, because both are required before energization.
CPI, SPI, EAC, VAC, and budget reconciliation — computed deterministically, narrated in plain English, defensible in front of finance.
Biological indicators, calibration status, cleaning validation reagents, gowning stock — the small details that cause 80% of delays, tracked automatically before they become critical path.
Batch classify 300+ vendor PDFs in hours, not days. Auto-tag by document type, vendor, system, and equipment tag. Low-confidence items enter a human review queue. Go from raw folder to structured registry before lunch.
Capital pharmaceutical projects span 18 months or more. People rotate off. Institutional knowledge walks out the door. Details fall through cracks — not because anyone was careless, but because no human can hold an entire CQV program in working memory for a year and a half.
DocSentry Ops maintains a living, structured model of your entire project — every system state, every prerequisite chain, every open question from every meeting, every vendor commitment and its lead time. It does not summarize and forget. It accumulates and connects.
When you tell it "autoclave is mechanically complete," it does not just log the update. It checks whether the boiler inspection has been scheduled and the pressure vessel permit obtained — because it knows both are required before energization for SAT. When someone mentions a BI order was placed yesterday, it cross-references the vendor lead time against your test schedule and flags that you are two weeks short.
It reads your meeting transcripts and field notes the way a senior PM would — extracting what matters, flagging what is late, and asking the question nobody remembered to ask. Except it does it every time, for every meeting, across every month of the project.
"Autoclave mechanically complete. Vendor finished yesterday."
Confirmed. Has boiler inspection been scheduled and pressure vessel permit obtained? Both are required before energization for SAT. Current schedule shows SAT beginning in 3 weeks — confirm permit timeline.
"BI order placed yesterday with Mesa Labs."
Lead time check: Mesa Labs typical turnaround is 6 weeks. Your schedule shows first heat penetration study in 4 weeks. This exceeds capacity by 2 weeks. Confirm BI ETA before committing to test date. Also confirm D-value cert and QC lab method qualification status.
"QC lab agreed to run 40 samples/week through validation."
Capacity flag: QC lab historical throughput is 25 samples/week. This schedule exceeds capacity by 60%. Consider staggering protocol execution or engaging a contract test lab.
Every tier is single-tenant, air-gapped, and behind your firewall. The difference is how much DocSentry you want to put to work.
Pay only for findings you confirm and act on. The lowest-risk way to put DocSentry against a real document set.
Unlimited audits across your active QMS. Continuous document intelligence as a flat monthly engagement.
Full document intelligence plus project orchestration. Built for multi-site capital programs.
Available on any tier. Adds project management intelligence to your appliance — meeting transcript ingestion, lifecycle state tracking, consultative prompting, schedule risk alerts, consumables monitoring, and native Excel/Word/PowerPoint output. Included by default with Enterprise.
Pricing is set per engagement. All tiers include single-tenant deployment, encrypted storage, verified data deletion at engagement end, and direct access to the Validation Labs team.
Reserve a pilot slot and we'll run DocSentry against a single protocol or SOP from your library — pay only for what we find.