SteriTrend
Industries

Environmental monitoring for pharmaceutical manufacturers

For GMP manufacturing sites with a cleanroom – human or veterinary medicines, in-house or contract manufacturing: environmental monitoring, deviations and validation, GMP-compliant in one web-based application.

Book a demo
Requirements

What GMP expects from monitoring.

Annex 1 of the EU GMP Guide makes environmental monitoring a central element of contamination control.

Trends, not single results

Results are to be reviewed regularly and checked for trends, so that deteriorating conditions are noticed before limits are exceeded.

Data integrity

Every step must be traceable: who took, read and assessed which sample, and when.

Deviations handled rigorously

Exceeding warning and action limits calls for investigation, assessment and actions – documented and on time.

How SteriTrend supports your site.

Mibi →

Sample plans in a daily view, barcodes from label to reading, an incubation timer that logs the actual incubation time, and the release process with digital signature.

Trends & Reports →

Trend analyses according to Annex 1, charts and reports with metrics such as the contamination rate – easy to print and at hand for regulatory audits.

Deviations →

An automatic event for every limit exceedance – with root cause analysis, actions with due dates and a deviation report.

Validation →

Initial validation and revalidation after manufacturing simulations, automatically; reminders of expiring validations; plus in-use validations and positive controls.

Companion app →

Scan samples right in the cleanroom and the lab, print labels and upload photos – on your phone or tablet.

Questions

Frequently asked.

Your answer not here? Write to us — we will get back to you as soon as possible. Contact

Is SteriTrend itself validated?
SteriTrend is developed according to GAMP 5. On request we provide documents for the internal validation of SteriTrend.
Is SteriTrend already used in the pharmaceutical industry?
Yes. SteriTrend is already in use in pharmaceutical manufacturing. We are happy to show you in a demo how environmental monitoring is mapped there.
Does SteriTrend support trend analysis according to Annex 1?
Yes. SteriTrend enables trend analyses according to EU GMP Annex 1 based on your recorded results, with numerous filter and grouping options. Setting your limits and assessing the trends remain your responsibility.
Is there an audit trail?
Yes. The audit trail documents every step without gaps – from sampling to report – and records which staff were involved.
Can SteriTrend be connected to a LIMS or ERP?
Yes, on request. We agree the connection to your existing systems with you individually. In any case, you can export your data as a CSV file at any time.
Can we map our existing SOPs?
Yes. Individual sample plans define what is done, when, where and how, and SteriTrend then guides you through the process.
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.
Book Demo

Book a demo now

In a roughly 60-minute demo we show you SteriTrend based on the workflows of your site.

Book demoGet in touch