Every piece of your workflow, already accounted for.
BioSure covers the full environmental monitoring cycle — intake, bench, report, delivery, audit — with six tightly integrated modules.
- Modules
- 6
- Setup
- 1–3 days
- Uptime
- 99.97%
- Compliance
- USP 797 · Part 11
/ 01
Chain of Custody
Digital intake from the first sample.
Replace paper CoC forms with a structured digital workflow. Clients submit their own, or your lab creates them.
- Digital creation & submission
- Draft → Submitted lifecycle
- Media lot tracking & sampler registry
/ 02
Sample Testing & Results
Every result, precisely recorded.
Enter CFU counts, organism identifications, plate images, and incubation parameters in one structured screen.
- Per-sample result entry
- Bacterial and fungal organism ID
- Plate image upload with compression
/ 03
One-click PDF report generator
Professional reports in seconds.
Generate full lab reports from CoC and result data — e-signatures, trending, floor plans, and organism descriptions.
- Automated PDF generation
- Report versioning with history
- Approval workflow (Under Review → Approved)
/ 04
Dedicated client portal
Every pharmacy client, their own workspace.
Pharmacy clients access reports, schedules, CoC submission, and trending from a dedicated, branded workspace.
- Self-service report access
- Real-time notifications
- Threaded comments on reports
/ 05
Scheduling & calendar
Never miss a submission deadline.
Recurring schedules with occurrence tracking and calendar views for lab and client visibility.
- Weekly, biweekly, monthly, or custom recurrence
- 12-month occurrence cache
- Client-visible schedules in portal
/ 06
Role-based access control
Security built for regulated environments.
Granular permissions with per-user overrides and comprehensive audit logging.
- Five user roles with per-module actions
- Per-user permission overrides
- Full audit trail for mutations
Report ID
SIGNED-REP_0421-v3
USP 797. 21 CFR Part 11 readiness. ISO 17025 support.
Workflows, e-signatures, and audit trails align with how inspectors review environmental monitoring programs. Enterprise adds formal compliance packages where required.
- USP 797
Aligned workflows
ISO classes, action levels, CoC fields, and report structure match what inspectors review.
- 21 CFR Part 11
Electronic signatures
E-signatures, audit trails, and access controls aligned with FDA electronic records expectations.
- ISO 17025
Competency & traceability
Enterprise package with competency tracking, calibration records, and full traceability documentation.
Signed by Dr. A. Mbeki — Lab Director · 2026-04-21 · 14:12 ET