SteriTrend
Trends & Reports

Annex 1 trend analysis and reports

Always stay up to date with continuous evaluations

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SteriTrend analyses with trend reports and hygiene reports

Trends

Trends according to Annex 1 GMP Guidelines can be monitored at any time. Thanks to numerous filter and grouping options, you can spot emerging trends at a glance.

Environmental Monitoring Reports

Use predefined reports with common metrics, such as contamination rate, to get an overview of the cleanroom status at any time.

Individual Analyses

Thanks to various filter and grouping options, SteriTrend supports all common metrics that you have used before. These are then individually compiled for you.

01

Floor plans

See at a glance where action is needed – directly on your building plan. Simply upload the floor plan, place measurement points, and identify trends.

SteriTrend floor plan with placed sampling points and trend indicators
02 · How and Where Needed

Print & Export

Your authority still wants to see paper? No problem. All reports can be easily downloaded and printed in a nicely formatted way.

Would you rather process the data yourself in Excel or other applications? Simply export as csv file and continue working.

SteriTrend export of reports and analyses

More features

Deviations →

Warning or action limit exceeded? SteriTrend creates the deviation automatically – with root cause analysis, actions and a deviation report.

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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Does SteriTrend support trend analysis according to Annex 1?
Yes. Annex 1 of the EU GMP Guide expects environmental monitoring results to be reviewed regularly and checked for trends, so that deteriorating conditions are noticed before limits are exceeded. SteriTrend creates these trend analyses straight from the data you already record during sampling and reading – no Excel lists. Setting your limits and assessing the trends remain your responsibility.
Can we keep evaluating our existing metrics?
Yes. Thanks to a wide range of filter and grouping options, SteriTrend supports all common metrics you have used so far, such as the contamination rate.
Which formats can reports be exported in?
Download reports as a formatted PDF or print them directly. Export the underlying data as a CSV file. The audit trail documents every step without gaps – from sampling to report.
How do I see where in the cleanroom a problem is developing?
With floor plans: conspicuous sampling points are visible on your building plan immediately instead of getting lost in tables.
Can I see when a sampling point is approaching a limit?
Yes. SteriTrend shows not only whether a single result exceeds a warning or action limit, but how the results of a sampling point develop over time. A sampling point that creeps closer to its warning limit week after week stands out before it turns into a deviation.
Can we evaluate which organisms are found?
Yes. You document the results of microbial differentiation directly in SteriTrend; stored house flora make recording quick and clear. The evaluation shows how your organism spectrum develops.
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