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.
Available validation profiles:
- AU eCTD (TGA)*
- AU NeeS (TGA)*
- BIH NeeS (ALMBIH)*
- CA eCTD (Health Canada)*
- CA Non-eCTD (Health Canada)*
- CA XML PM (Health Canada)
- CH eCTD (Swissmedic)*
- CH eDok (Swissmedic)
- CN eCTD (CDE)*
- CN eSubmission (CDE)*
- ECOWAS eCTD (WAHO)*
- ECOWAS eSubmission (WAHO)*
- eCTD MD5/SHA256 Proofreader*
- EU eCTD (EMA)*
- EU NeeS (EMA)*
- EU VNeeS (EMA)
- GCC eCTD*
- GCC VNeeS
- KSA NeeS*
- KR eCTD (MFDS)*
- JO eCTD (JFDA)*
- JP eCTD 3.2 (PDMA)*
- JP eCTD 4.0 (PDMA)*
- PDF QC (US FDA Requirements)*
- SG eCTD (HSA)*
- Statistical information profile*
- TH eCTD (Thai FDA)*
- TW eCTD (TFDA)*
- UA eCTD (SEC)*
- US CDRH eCopy (US FDA)*
- US eCTD 3.2 (US FDA)*
- US eCTD 4.0 (US FDA)
- US PDF QC (US FDA)*
- WHO PQT eCTD*
- ZA eCTD (SAHPRA)*
- ZA eSubmission (SAHPRA)*
* There is an extended version for the marked profiles.