SteriTrend
Deviations

Deviation management in environmental monitoring

Document out-of-limit events easily and clearly

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Microbial Differentiation

Easily manage deviation reports with all relevant information

SteriTrend germ differentiation of a microbiological sample

Initiate Differentiation

Select samples for differentiation, add laboratory, and print sample accompanying sheet. Everything done with just a few clicks.

Record Microbes

Easily document and later evaluate differentiation results. Thanks to stored facility-specific environmental isolates, quick and clear overview.

Deviation Reports

All relevant data in one report for each deviation. Also available as PDF download or print version.

Warning & Action Limits

01

Deviation Management

Each limit exceedance is recorded as its own event and can be enriched with additional information such as root cause analysis, risk assessment, and product risk. Document preventive and corrective actions directly in SteriTrend. Of course, also with corresponding due dates and reminders.

SteriTrend deviation report in print view
02

Notifications and Reminders

Whether by email or as a message in SteriTrend, you are informed immediately if a warning limit or action limit is exceeded. This allows you to react as quickly as possible. Due dates for corrective actions are also displayed by the system.

SteriTrend notification for a deviation

More features

Trends & Reports →

Automatic trend analysis per EU GMP Annex 1: warning and action limits in view, organism spectrum, and reports as PDF or CSV.

Mibi →

Work through environmental monitoring sample plans digitally: record samples by barcode, document incubation and reading GMP-compliantly.

Validation →

Operator and process validation, digitally: document manufacturing simulations, in-use validations and positive controls GMP-compliantly.

Questions

Frequently asked.

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When does SteriTrend create a deviation?
Automatically, as soon as a result exceeds a warning or action limit. Every exceedance is recorded as its own event.
How are we informed about deviations?
By email or as a message in SteriTrend. The system also shows due dates for corrective actions.
Can we document differentiation by an external laboratory?
Yes. You select the samples, add the laboratory and print the sample accompanying sheet. You then record the results in SteriTrend.
Can the deviation report be printed?
Yes. The deviation report contains all relevant data on the deviation and is available as a PDF download or print version.
What happens after a limit is exceeded?
Notification, microbial differentiation, root cause analysis and risk assessment, actions and finally the deviation report. Every step is documented in the audit trail.
Where do we document root cause analysis and risk assessment?
Directly on the event in SteriTrend instead of separate forms – including product risk. All information on a deviation stays in one place.
How do we keep track of actions?
Create preventive and corrective actions directly on the event, with due dates. SteriTrend reminds you of upcoming actions, so none is left undone.
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