/ MICROBIOLOGY & COMPLIANCE
Microbiological compliance with GMP standards
Process Tempo ensures the safety of your sterile production environments. We qualify your cleanrooms and design your microbiological sampling plans in accordance with the most stringent GMP requirements.
PHYSICAL INSPECTIONS
Sterile Risk Management
Our experts provide on-site support to ensure that your controlled-atmosphere areas remain compliant, from routine metrology to critical management of post-audit deviations.
VALIDATION
METHODOLOGY
COMPLIANCE
Classification of cleanrooms
HACCP Monitoring
Deviation Reports
Microbiological classification of air and surfaces. We develop your cleanroom qualification protocols in strict compliance with Annex 1 of the GMP guidelines.
We develop detailed sampling plans based on HACCP risk analysis. We identify critical control points to prevent microbial contamination.
A systematic analysis of your compliance gaps. We prepare structured and well-reasoned non-compliance reports, ready for your regulatory inspections.
+ NEXT STEP FOR Q4 2026
Automation of quality control
We are developing a suite of no-code AI agents specifically trained for bioproduction workflows. This system will automate the analysis of microbiological trends and validate your data in real time by the end of 2026.
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Ready for your next audit?
Get an assessment of your environmental monitoring practices. Our Paris-based consultants will help you structure your methods to ensure compliance with all regulatory requirements.