Reshape for Pharma QC
A zero you can’t verify is your riskiest result.
From automated colony counting and plate sorting to digital review and sample traceability, Reshape brings greater consistency, efficiency, and confidence to pharmaceutical environmental monitoring.
The problem
A negative result still needs evidence.
<1%
of Grade A plates should show any growth. 0 CFU is the limit – anything above it is investigated.
EU GMP Annex 1 (2022) · USP <1116> Table 3
50%
difference between operators, across 13,000+ plates. Most miscounts were colonies of 53–63 µm – the smallest on the plate.
Marsit et al, Discover Pharmeceutical Sciences (2025), citing Sandle, J GxP Compliance (2020)
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.
120,000 plates/yr x 42-128 s a plate. Microbiology Spectrum read-time studies (2022-2023)
FDA has found growth recorded as zero – more than once.
- 2011Growth not identified
- 2019Growth recorded as “Nil”
- 2020Uncountable plate logged as zero
- 2026Growth 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 · 9.27
QA oversight of every result, including remote review
EU GMP Annex 1 · 9.11
Digital records that make trending easy
EU GMP Annex 1 · 9.31
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
Reshape for Pharma QC
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The full Reshape QC workflow, device specification and qualification approach in one document.
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