Data integrity for Biopharma
Automated!

Real-time alerts and data flagging to proactively be compliant with regulations

FDA CGMP ICH EMA

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The best way to avoid risk is to not introduce it in the first place
-ISO 14971

Integrate with your existing data sources

Seamlessly integrate with all existing instruments, databases, and data sources to initiate alerts when deviations are recorded.

Customize personnel profiles to monitor tasks

Define the roles and responsibilities of each stakeholder to establish seamless, error-free processes.

Address alerts & data issues in real-time

Pre-configured templates based on FDA, ICH, cGMP, and ISO data integrity regulations generate auto alerts to avoid introducing discrepancies in the system.

Be Proactive not Reactive

Significantly reduce the RCA and CAPA processes by reducing the number of deviations at the source and comply with Continous Process verification (CPV)