Easily manage your GMP
environmental monitoring data
Traceability and security - DATA INTEGRITY
Ensure the compliance of your environmental data
In a constantly evolving regulatory environment, particularly with the new requirements of Annex 1 (annex related to the manufacture of sterile medicinal products), mastering environmental parameters has become a strategic priority for players in the pharmaceutical industry.
Temperature, humidity, particles, or differential pressure: these data, critical for product quality, must not only be monitored in real time, but also proactively analyzed to anticipate any risk of deviation. Annex 1 has evolved toward prediction since 2020, making trend monitoring mandatory in August 2023.
It is with this objective in mind that we have designed a trend analysis module fully integrated into our monitoring solution. This innovative module allows you to quickly identify trends in your measurement points and make informed decisions before an alarm threshold is even reached.
✔️ Rapid identification of trends to secure your audits
✔️ Traceability and actionable reports with a single click
Thanks to a user-friendly interface and powerful statistical tools, you gain reactivity, reliability, and above all, peace of mind in the face of regulatory requirements.
Risk reduction in sterile areas
GMP monitoring software module, combining simplicity, performance and anticipation
Beyond simple monitoring, our module helps you detect deviations early from expected behaviors. An abnormal variation, even if it does not trigger an immediate alarm, is identified and reported. This allows you to implement corrective actions without delay, reducing the risks of non-compliance or production disruptions.
✔️ Early detection of deviations for immediate corrective actions
✔️ Reduction of non-compliance risks
Annex 1 of Good Manufacturing Practices (GMP)
5.2 Equipment monitoring requirements should be defined in “user requirements specifications” during early stages of development, and confirmed during qualification. Process and equipment alarm events should be acknowledged and evaluated for trends. The frequency at which alarms are assessed should be based on their criticality (with critical alarms reviewed immediately).
6.4 Results for critical parameters and critical quality attributes of high risk utilities should be subject to regular trend analysis to ensure that system capabilities remain appropriate.
These risk assessments should be reviewed regularly in order to confirm the effectiveness of the site’s environmental monitoring programme. The monitoring programme should be considered in the overall context of the trend analysis and the CCS for the site.
9.9 Appropriate alert levels and action limits should be set for the results of viable and total particle monitoring. The maximum total particle action limits are described in Table 5 and the maximum viable particle action limits are described in Table 6. However, more stringent action limits may be applied based on data trending, the nature of the process or as determined within the CCS. Both viable and total particle alert levels should be established based on results of cleanroom qualification tests and periodically reviewed based on ongoing trend data.
TIME SAVINGS
Business intelligence for effective decisions
The integrated analysis engine relies on proven statistical algorithms, enabling the identification of significant variations in your data series. Whether for a periodic review or as part of an audit, you have access to precise and understandable analyses, generated automatically.
✔️ Identification of significant variations
✔️ Automation of reports for time savings
Smart, personalised control
Alarm management and continuous monitoring
The module is closely linked to the alarm monitoring: it enables not only a continuous monitoring of threshold exceedances but also the customization of indicators based on the needs of your environment or quality protocols. This allows you to maintain optimal control of your monitoring chain, 24/7.
✔️ Custom indicators when thresholds are exceeded
✔️ Continuous monitoring for optimal control
With this module, you can transform your environmental data into a real lever for quality performance. You gain visibility and responsiveness, and you are ready to face any audit—with clear, reliable, and ready-to-use reports.