<1%
of Grade A plates should show any growth. 0 CFU is the limit – anything above it is investigated.
[Source: EU GMP Annex 1 (2022) · USP <1116> – confirm citation]
The problem
A negative result still needs evidence.
50%
difference between operators, across 13,000+ plates. Most miscounts were colonies of 53–63 µm – the smallest on the plate.
[Source: 13,000+ plate operator study – confirm citation]
1,400–4,300
reading hours a year at 10,000 plates a month. Every empty plate still costs a microbiologist’s time – often twice.
[Source: read-time basis for 10,000 plates/month – confirm citation]
FDA has found growth recorded as zero – more than once.
- Growth not identified
- Growth recorded as “Nil”
- Uncountable plate logged as zero
- Growth plates swapped for clean
You cannot review a plate that was never recorded.
FDA warning letters, 2011–2026. Sites not named.
An image behind every result – for QA, trending and investigations
The plate image is the original record. It stays with the count, the reader and the time so a questioned result can be reviewed instead of re-argued.
Reshape your workflow with high throughput testing & zero hassle
High precision tech designed to process 700 plates per hour
-
01 Pre-analytical
Sample trackingTrack Every Sample
Link samples to barcodes and relevant metadata, creating a traceable record before analysis begins.
-
02 Analytical
AI-powered analysisAutomate Plate Reading
Capture and analyze microbial culture plates with standardized AI models and automatically flag results for review.
-
03 Post-analytical
Digital traceabilityReview with Confidence
Access images, results, and activity history.
Support in labs through Grade A → D
An image behind every result – for QC, QA, trending and investigations.
The plate image is the original record. It stays with the count, the reader and the time, so a questioned result can be reviewed instead of re-argued.
ALCOA+
Image kept as the record
21 CFR Part 11
Designed to support 21 CFR Part 11 audit trail and secure records
EU GMP Annex 1 · [§ ref]
QA oversight of every result, including remote review
EU GMP Annex 1 · [§ ref]
Digital records that make trending easy
EU GMP Annex 1 · [§ ref]
Patterns visible for investigations
EU GMP Annex 1 · Table 6
Reported in CFU
Certifications and frameworks
- SOC 2 Type II
- ISO 27001
- 21 CFR Part 11
- ISO 17025
- GAMP 5
Qualification
Qualified under cGMP in five signed records.
The model is tuned on your own plates first. PQ tests it against your analysts to criteria agreed up front.
- 01Plan
- 02Workspace IQ/OQ
- 03Device IQ/OQ
- 04PQ per method
- 05Analysis OQ/PQ
