BioSureBioSure
Environmental monitoring LIMS · v2.4For USP 797 compounding pharmacies

Run your entireUSP 797 programin one place.

BioSure replaces spreadsheets, paper chain-of-custody, and legacy LIMS with one cloud platform for environmental monitoring labs. Unlimited client seats, real-time audit trail, signed PDF reports in minutes.

Compliant withUSP 79721 CFR Part 11HIPAAISO 1702547 states

Early outcomes

live
Report turnaround

6h → 20 min

-68%
Audit pass rate

Across 182k reports

99.9%
Time to first report

From signup to signed PDF

1-3 days
Scientists using the BioSure platform in a modern microbiology lab

Active CoC

EM · 2026-04-21

SUBMITTED

ISO-5 sample 04

2 CFU

Pass
Report signed · 20m 14s
02The shift

Compounding labs don't lose contracts because their microbiology was wrong.They lose them because the paperwork was late.

Most environmental monitoring programs still run on a mix of clipboards, Word templates, email, and a legacy LIMS built for clinical diagnostics. BioSure rebuilds the workflow end-to-end.

Before BioSure

The way most labs run today.

  • Chain-of-custody forms scattered across clipboards, PDFs, and email attachments
  • Reports manually reassembled in Word — inconsistent signatures, missing trend charts
  • Pharmacy clients calling your lab at 5pm asking for last month's results
  • A state inspector arrives and your QA manager disappears for three days
  • Plate reads transcribed twice — once on paper, once into a spreadsheet

With BioSure

One cloud platform, every step accounted for.

  • One digital CoC per sampling visit. Signed on-site, timestamped, immutable.
  • Signed PDF reports auto-assembled — trending, z-scores, and limits built in.
  • Every pharmacy client has their own portal. Unlimited seats, zero extra cost.
  • Audit trail surfaces any data point in three clicks. Ready in minutes, not days.
  • Reshape AI reads plates. Your team verifies. Numbers flow straight to the report.
03Capabilities

One platform. Sample to report.

Stop duct-taping spreadsheets, Word docs, and email threads. BioSure handles the complete environmental monitoring workflow in one place — every module works in concert, every record is audit-ready by default.

Browse every capability
/ 01Chain of custody

Chain of Custody

Digital intake from the first sample.

  • Digital creation & submission
  • Draft → Submitted lifecycle
  • Media lot tracking & sampler registry
  • Automated sample ID generation
Read the brief
/ 02Sample results

Sample Testing & Results

Every result, precisely recorded.

  • Per-sample result entry
  • Bacterial and fungal organism ID
  • Plate image upload with compression
Read the brief
/ 03PDF reports

One-click PDF report generator

Professional reports in seconds.

  • Automated PDF generation
  • Report versioning with history
  • Approval workflow (Under Review → Approved)
  • Bulk ZIP download
Read the brief
/ 04Client portal

Dedicated client portal

Every pharmacy client, their own workspace.

  • Self-service report access
  • Real-time notifications
  • Threaded comments on reports
Read the brief
/ 05Scheduling

Scheduling & calendar

Never miss a submission deadline.

  • Weekly, biweekly, monthly, or custom recurrence
  • 12-month occurrence cache
  • Client-visible schedules in portal
Read the brief
/ 06Access control

Role-based access control

Security built for regulated environments.

  • Five user roles with per-module actions
  • Per-user permission overrides
  • Full audit trail for mutations
Read the brief
04How it works

Three phases. One source of truth.

Every handoff that used to live in an email, a clipboard, or a spreadsheet now happens inside BioSure — attributed, timestamped, and visible to every stakeholder.

  1. Phase 01 · Collect~45 seconds

    Sample intake in under a minute.

    Scan a QR on the sampling kit, capture location and tech on-device, and a digital chain-of-custody opens with a cryptographic signature. No clipboards, no re-entry.

    • Mobile-first intake forms
    • On-device signatures
    • Photo evidence attached
  2. Phase 02 · AnalyzeSame-day turnaround

    Incubate, read, and verify with one source of truth.

    Reshape AI reads plates and flags colony counts. Your microbiologist verifies with one tap. Every result is time-stamped, attributed, and tied to the originating CoC.

    • AI plate imaging + CFU counting
    • Two-factor reviewer sign-off
    • Live trend & limit alerts
  3. Phase 03 · Report20-minute average

    Signed PDF, delivered to the client portal.

    BioSure assembles a USP 797-ready report with trending, z-scores, and audit trail baked in. Your pharmacy client sees it the moment you click release — from their own dedicated portal.

    • Auto-assembled trend charts
    • Digitally signed PDFs
    • Dedicated per-client portals
05Proof

Numbers from real labs,voices from their QA desks.

BioSure customers publish 18,000+ signed reports every month. Here's what it adds up to — and what they say when you're not in the room.

Report turnaround

0%

From a 6-hour grind to a 20-minute assembly.

Audit pass rate

0%

Across 182k reports signed on BioSure.

U.S. states

0

Labs running compliant EM programs.

Uptime SLA

0%

Measured across every customer region in 2025.

What used to take three hours per report is now a single click. Our team closed out a month of sampling events in the time it used to take us to close one week.
Lab director portrait

Dr. Sarah Whelan

Lab Director · Meridian Environmental

The portal changed our relationship with our pharmacy clients. Status inquiry calls dropped from twenty a week to almost zero.
Operations lead portrait

Marcus Okafor

Operations Lead · Northstar Compounding QC

First inspection after moving to BioSure was the smoothest we've ever had. Every record the inspector asked for was on-screen in seconds.
QA manager at workstation

Lena Park

QA Manager · Horizon Hospital Pharmacy

11Common questions

Straight answers before you start.

Setup, compliance, data ownership, security — no gatekeeping, no salesperson gymnastics.

Ask a questionReplies within 1 business day
  • BioSure is a cloud-native LIMS built specifically for environmental monitoring labs performing USP 797 testing. It manages your entire workflow — from chain-of-custody intake through sample testing, PDF report generation, and client delivery.

The last LIMS onboarding you’ll ever book

Ready to replace the duct tape?

Walk through BioSure with a product specialist. Bring one pharmacy client, one sampling event, and we’ll show you a signed report before the meeting ends.

Onboarded in 1–3 daysFull data export anytimeHIPAA BAA · SOC 2 infrastructure