Validation Profiles for eValidator FIVE
eValidator FIVE includes current and previous validation criteria addressing the exact requirements as published by the regulatory agencies. In addition, it offers extended profiles with additional checks. With eValidator FIVE you also have the ability to customize profiles.
Available validation profiles:
- AU eCTD (TGA)
- AU NeeS (TGA)
- BIH NeeS (ALMBIH)
- CA eCTD (Health Canada)
- CA Non-eCTD (Health Canada)
- CH eCTD (Swissmedic)
- CH eDok (Swissmedic)
- CN eCTD (CDE)
- ECOWAS eCTD (South Africa)
- eCTD MD5 Proofreader
- EU eCTD (EMA)
- EU NeeS (EMA)
- EU VNeeS (EMA)
- GCC eCTD and KSA NeeS
- GCC VNeeS
- JO eCTD (JFDA)
- PDF QC (US FDA Requirements)
- SG eCTD (HSA)
- Statistical information profile
- TH eCTD (Thai FDA)
- TW eCTD (TFDA)
- US CDRH eCopy (US FDA)
- US eCTD 3.2 (US FDA)
- US eCTD 4.0 (US FDA)
- ZA eCTD (MCC)
Extended validation profiles:
- AU NeeS extended
- CH eCTD extended
- EU eCTD extended
- GCC eCTD extended
- JO eCTD extended
- JP eCTD extended
- KSA NeeS extended
- TH eCTD extended
- US eCTD extended
- ZA eCTD extended