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ErgoLIMS for Microbiology Testing
28 methods · 12 instruments · 12 limits on day one

A count is only a count if the chain behind it holds.

Microbiology is the discipline where the paperwork is the result. ErgoLIMS holds the holding time, the incubation window, the media lot, the analyst's authorisation and the environmental record against every plate you read.

IS 5401 / 5402 / 5403
ISO 4833-1
IP 2022 · USP <61>/<71>
NABL

Plates and colonies — drawn live in the browser, no two frames alike

The problem

Everything that invalidates a micro result happens before the plate is read

The sample sat at ambient for five hours. The media lot was never growth-promoted. The incubator drifted overnight and nobody logged it. The analyst reading the plate was signed off for enumeration, not for pathogen confirmation. None of that appears on the report — and all of it is what an assessor asks about.

Holding time and cold chain tracked on paper, if at all
Media QC and incubator records live outside the result
No structural link between a plate count and who was authorised to read it
What ErgoLIMS does about it

Six things a microbiology lab gets that a spreadsheet cannot give it

Each of these is a shipped capability, not a roadmap item.

Holding time is captured at the door

Date of collection, time of collection and temperature at receipt are structured registration fields on every microbiology sample — not a note in a remarks box. The clock that decides whether a result is reportable starts on the record itself.

You can prove the sample was still valid when it was plated.

Only a cleared analyst can report the organism

Per-method authorisations carry a competency level and an expiry date. If an analyst's sign-off for Salmonella confirmation has lapsed, result entry refuses the save with ANALYST_NOT_AUTHORIZED — on the server, not as a warning the browser can skip.

Competency is enforced at the moment of work, not audited afterwards.

An out-of-calibration incubator cannot report

Incubators, autoclaves, air samplers and biosafety cabinets sit in the instrument register with calibration and preventive-maintenance schedules. The day a calibration lapses the instrument locks out and any result claiming it is refused.

No result ever carries an instrument that was out of date on the day.

Absent/present is evaluated, not typed

Pathogen methods are configured as text-result tests with their limit expressed the way the standard writes it — 'Absent in 25 g', 'Shall not be detectable in any 100 mL sample'. A detection is flagged on entry and opens an out-of-specification investigation before anyone drafts a certificate.

A positive is escalated the moment it is entered, not at review.

Media and reagents trace to the plate

Prepared media, reference strains and reagents are inventory items with expiry tracking and first-expired-first-out issue. Consumption is recorded against the test that used it, so a growth-promotion failure can be traced to every result the lot touched.

One media lot failure becomes a bounded recall, not an open question.

Environmental monitoring runs on the same spine

Settle plates, active air, surface contact and personnel monitoring are seeded as methods with EU GMP Annex 1 and ISO 14698 limits, so cleanroom data lives in the same system, on the same audit trail, as the product it protects.

Room data and product data can finally be read together.
End to end

How a microbiology sample moves through the system

Receive with the clock running — The registration form — three steps, with the customer-committed date and the internal lab target kept as separate fields.

The registration form — three steps, with the customer-committed date and the internal lab target kept as separate fields.

Cold chain checkHolding timeChain of custody
Who it is for

Three people in the lab, three different wins

Microbiologist

The system tells you before you start whether you are cleared for this method and whether the incubator is in date — instead of a reviewer telling you a week later.

Quality Manager

Media QC, environmental monitoring, competency expiry and OOS investigations are one query, not five folders.

Lab Director

Every count on a released certificate traces to an authorised analyst, a calibrated incubator and a growth-promoted media lot.

Built to be assessed

Compliance a microbiology assessor will recognise

ISO/IEC 17025 §6.2 — personnel

Skills register, per-method authorisation with expiry, training records and certifications, enforced at result entry rather than filed for the assessor.

IP 2022 / USP <61>, <62>, <71>, <85>

Non-sterile enumeration, specified organisms, sterility and bacterial endotoxin seeded as methods with their published acceptance criteria.

EU GMP Annex 1 · ISO 14698

Settle plate, active air, surface and personnel monitoring with grade-based alert limits available as standard methods.

21 CFR Part 11

Electronic signatures with identity challenge and reason capture; the audit trail is append-only and enforced by database triggers, not by the interface.

And you do not start from an empty system

Choose the microbiology domain at setup and ErgoLIMS provisions the scaffolding for you — as editable templates, not a locked configuration. Limits shown arrive pre-loaded for the domain. They are editable, versioned and can be overridden per customer or per product.

5
Departments
28
Test methods
12
Instruments
12
Spec limits
Asked by labs like yours

Questions we hear from microbiology labs

The monitoring methods — settle plate, active air, surface contact, personnel — are seeded with EU GMP Annex 1 grade limits and run through the same result entry, review and audit trail as product testing. A dedicated EM scheduling and mapping screen is on the roadmap; today you run EM as testing work against monitoring locations you define.

See it run on your own parameters

A 30-minute walkthrough with the engineers who built it — using your methods, your limits and your reporting format, not a canned script.