Bioequivalence and Bioavailability Forum

Dear All,

I have a general question about EU pharmaceutical regulatory affairs, it does not really fit into the topics discussed on this forum, but maybe you could point me to a suitable forum.

I would like to know more about the EU requirements on electronic storage of registration dossiers of marketing authorisations. Specifically, i would like to know if the following setup would suffice as per EU guidelines.

The registration dossier / MA is stored electronically, the rights to add, modify or delete data are restricted to members of the RA department (through windows network security to restrict the rights of each user). All variations, approvals, rejections and communication between regulatory authority and the MA holder are also stored electronically and can only be added, modified or deleted by members of the RA department. There are no hardcopies of the dossier, variations or correspondence (all original signed documents are scanned in, but the original hardcopy is also kept. Hardcopies of other documents are not kept).

• Is the above storage of registration dossiers, variations and correspondence acceptable as per eu regulatory guidelines?
  
• Is there any guideline relevant to EU countries that contains information or guidance with regard to the electronic storage of registration dossiers?
  
• The rights to add, modify or delete data in the RA directories are arranged through the standard option of a windows server to grant these rights to some users and not to other users. Obviously we have checked if it works properly by logging in as a user that does not belong to the RA department (and then try to modify, add and delete data) and subsequently as a user that does belong to the RA department (and then try to modify, add and delete data). Only the windows network administrator can change the security settings. With storage of RA information for EU market, can you rely on such windows security, or should one carry our validations, etc.?
  
• In the past, we noted that some companies signed all pages of a registration dossier which has been approved. That is currently is practically impossible, since the amount of pages is huge. Is there any requirement to put e.g. a signature and/or the approval date on each page of an approved module?

Many thanks in advance for pointing me in the right direction to where i could seek answers to these questions.

Best regards,

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Edit: Category changed, subject line modified. [Helmut]