What is PDMS?

The following brief descriptions are of the key features of the PDMS application and its operations.

PDMS is a number of programs in a single application designed to make the submission of drug approval documents a simpler task. PDMS operates in a GUI (Graphics User Interface environment) and is fully MDI (Multiple Document Interface) compliant.

With PDMS you can create the chemical-pharmaceutical part of the registration application under the European Union format; quickly and simply manage the document sets throughout the preparation, approval and post- approval process. Also you can check the quality of the documentation and work with a number of projects at the same time.

The PDMS has extensive security features and offers extensive help on filling these forms, along with European Union legislation.


Chemical pharmaceutical registration
PDMS has full elaborated application formats with direct links to practical extensive help facilities based on the current CPMP (Committee for Proprietary Medicinal Products) and ICH (International Conference on Harmonisation) Guidelines and consultancy expertise.


Manage document sets
PDMS has full featured text editing. With the PDMS you can edit any page within a document at any time; delete appended pages at any time; create additional pages at any time; export the document set to other PDMS systems at any time; and import into the document set any text or graphic. The editor also allows for multiple 'undo' operations.

Pages, or sets of pages, can be simply duplicated and inserted elsewhere into the document. Sets of text and graphics can be inserted into existing pages as often as necessary during the development process, up to ten levels within a single page.

There is a 'comment' area for each page which keeps the development status of the page. Status information such as: has the page been completed or not completed; if the page has been or is to be printed, or a page is not to be printed.


Library package
The PDMS Librarian allows for the storage and retrieval of text and graphical objects frequently used in the production of document sets.


Check the quality of the documentation
Help is linked to each individual part of the application and offers the possibility to quickly check the quality and completeness of the documentation.

Pages can be inserted for internal/external expert or assessment reports.


Multiple document interface
PDMS allows for multiple projects to be edited at the same time.

PDMS allows fast access to documents sets. The system will access pages quickly regardless of document size. PDMS allows document sets in excess 1,000,000 pages.

The system automatically handles the storing and saving of file information about each project. This means that users do not need to worry about handling project files.


Help system
The extensive help system assists in finding all information needed to complete a document. The Help system is context sensitive and fully interactive.

Help is available on:
How PDMS programs operate.
Pharmaceutical technical help. Expert help on the filling out of document pages, and lists of common responses specific to each document page. Help is also available on Pharmaceutical legislation (drug approval procedures and EU/ICH guidelines) and consultancy expertise.
Statistical help is available detailing the computation of statistics relevant to 'analytical method validation' and relevant to 'stability testing and shelf life prediction'.


Security features
Security is managed with the use of passwords, and controlled by designated system managers.

There are a number of user privilege levels:
all users with accounts are allowed to open projects.
the system manager can preferentially select or de-select a number of functions for projects, such as:
new, rename, delete, duplicate, import, export

Physical security is implemented by means of a hardware key supplied with each copy of the software. The software will not run without the hardware key.





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