Role · Quality assurance and QP
For QA and QP: assessments that stand up to inspection.
M7, nitrosamines, stability and changes with input data, calculation path and limits. The assessment stays with you.
What we solve for you
Mutagenicity and nitrosamines (ICH M7)
The authority wants to see our nitrosamine assessment, and external reports take weeks.
See solutionStability, degradation, forced degradation
One result in our stability study looks different, and we do not know whether it is a trend or scatter.
See solutionOOS, control charts, release data
An OOS result is holding the batch, and the investigation has been stuck for weeks.
See solutionChange and comparability
The column is discontinued, the instrument is new, the supplier has changed: can we do this without revalidation?
See solutionCleaning validation
For our multi-product facility we have to justify the worst-case marker and the limit.
See solutionGxP evidence, audit trail, model documentation
We can only use AI results if every step is traceable.
See solution
Evaluated for you, done yourself or learned
Evaluated for you
You send the data, we deliver the reviewed report. From EUR 1,490 net, typically 5 working days after complete data.
See reportPilot project
One question on your data, with a success criterion agreed in writing beforehand. From EUR 1,490 net, fully creditable.
See pilot projectDo it yourself
One seat for you, cancel monthly. EUR 0, 250 or 750 per user and month, net.
Try it freeLearn
Your team learns it on its own data, online or in Leipzig. EUR 490 to 1,990 per person, in-house EUR 3,500 to 9,900, net.
See learning
Next step
Which case is on your desk right now?
30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.