SteriTrend
Validation

Validation of operators and processes

Capture and evaluate validations automatically

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Employee Validation

01

Automated

Let the system automatically record initial and revalidation. As soon as the required number of successful manufacturing simulations has been recorded, the employee's status is automatically adjusted.

SteriTrend overview of personnel validations
02

Notifications

Reminders and notifications about relevant events, such as upcoming validation expiries, successful revalidation, or failed attempts. Both via email and as messages in SteriTrend. Individually configurable for each user.

SteriTrend notification for expiring validations

Process Validation

Relevant processes continuously monitored and their safety documented

Documentation

Seamlessly document and evaluate filter changes, cleanroom modifications, and other events through cleaning controls to always maintain a complete overview.

In-Use Validation

Multiple withdrawals from the original container? Interim storage in the refrigerator? In-use validation in SteriTrend reliably supports you and guarantees GMP-compliant work.

Positive Controls

Do you need your own growth evidence in addition to the test certificates from media manufacturers, e.g., with your facility-specific environmental isolates? The positive controls in SteriTrend enable you to do this without distorting the statistics.

More features

Mibi →

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

Deviations →

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

Trends & Reports →

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

Questions

Frequently asked.

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Is SteriTrend itself validated?
SteriTrend is developed according to GAMP 5. On request we provide documents for the internal validation of SteriTrend.
How does automatic revalidation work?
SteriTrend records initial validations and revalidations automatically. As soon as the required number of successful manufacturing simulations has been recorded, the system adjusts the person's status.
Are we reminded of expiring validations?
Yes, by email or as a message in SteriTrend. Notifications are configurable for each user.
Does SteriTrend support validation of incubators and other equipment?
SteriTrend does not offer equipment validation. You can, however, record the calibration date of your equipment, such as incubators, and SteriTrend reminds you before the next calibration is due.
Do positive controls distort the statistics?
No. Positive controls are recorded in SteriTrend in a way that does not distort the statistics of your environmental monitoring.
What is an in-use validation?
Multiple withdrawals from the original container or interim storage in the fridge: with in-use validation you document, GMP-compliantly, that opened containers can continue to be used under your conditions.
Can we document cleaning controls?
Yes. Document and evaluate filter changes, cleanroom modifications and other events without gaps through cleaning controls. That way you keep track of whether relevant processes remain safe.
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In a 60-minute demo, we'll be happy to show you the details of our validation functions for your individual use case.

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