The issue of regulatory compliance in the Bio-Pharmaceutical manufacturing industry has never been as important – or challenging – as it is today. Regulatory filings need reliable data supporting upstream process development activities.
When engaged at the outset of a program, the Mystro® Data Management system automatically creates a comprehensive archive of every batch and the status of each monitored process parameter throughout the entire batch run. Every analyzer sample is synchronized via batch ID, every parameter variance is recorded, every comment or observation made by operators is captured and associated with the batch in question and the time at which the observation is made.
