A Computer Assisted New Drug Application program especially designed for the chemical-pharmaceutical part of the registration application under the European Union format.
PDMS operates in a GUI (Graphics User Interface) environment and is fully MDI (Multiple Document Interface) compliant. PDMS is designed for reliability and speed and help files make the program User Friendly.
Full elaborated application formats with direct links to practical context sensitive help based on the current CPMP and ICH Guidelines and consultancy expertise.
An display tree allows for easy navigation through the application formats. Functionality tools assure the completeness of each part of the application documentation.
Featured text editing particularly developed for a quick and simply managedt document sets throughout the preparation, approval and post-approval.
Each page can also be linked with an additional editor for personal comments.
Project access levels can be assigned to users by a system administrator.
Physical security is implemented by means of a hardware key.
Documents, images can be stored in a customised library.
Adopted CPMP/ICH guidelines, statistical help detailing the computation of statistics relevant, analytical method validation' and relevant to, stability testing and shelf life prediction' can be retrieved from additional inbuilt libraries.