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SMARTSTATS
Software for analytical method transfer
Your focus: statistical report writing
SMARTSTATS is an umbrella software consisting of modules that facilitate report generation in line with all kinds of guidelines and authority (EMA/FDA/MHLW) expectations.
Value for you:
- Standardize reporting across the organisation
- Up-to-date with latest authority requirements (EMA, FDA, …)
- Suitable for GxP use (GAMP5 validated, 21 CRF Part 11 compliant)
- SaaS: no maintenance cost for you (i.e. we maintain it for you)
- Save cost and time in report writing
- Significantly reduce human errors
- Go further dan Excel (e.g. REML, quantile computation, etc.) to always give exact statistical results
- Easy to use, even for non-statisticians
- Best-in-class decision making
Our statisticians provide support for any questions concerning the use of the software and the processing of your data.
Features
Generate eCTD reports in compliance with authority expectations:
- Enoval: module for analytical method validation (physico-chemical) in line with ICH Q2(R2).
- More to come…
To find out more or request a demonstration
Related Resources
Related Services
- Custom Software Development
- Lab Tools
- SMARTENOVAL – analytical method validation software
- SMARTSEELVA – bioassay validation software
- SMARTSTABELITY – product stability and shelf-life estimation software
- SMARTTRANSVAL – analytical method transfer software
- Statistical Training
- Statistics and Data Sciences
- Statistics Software Login
