Our software products have been developed regarding to policies of software ergonomics and in compliance with recommendations and specifications of GxP and GAMP5. This ensures that these software products are validated, GxP compliant, user friendly, future-oriented and safe. Thanks to the support of our PV Services department the software products are implemented very close to the needs of a good pharmacovigilance.

The special characteristic of our software products is the realisation as a Multi-Core Database System. This system allows including different subenvironments in one environment. If required we set up an environment for clients with different affiliates in such a system. This makes it possible to maintain the data of the affiliates independently of each other in the same environment. For other clients we set up just one environment for their own.

Currently Pharmacovigilance database saphŽus and XEVMPD database -iris- can be purchased.




Pharmacovigilance Database saphŽus
saphŽus is a modern und future-proof pharmacovigilance database that is compliant with currently legal requirements and prepared for future changes already.

The following benefits characterise saphŽus:
- saphŽus is a E2B compatible full pharmacovigilance database that includes different additional fields
- gateway for exchange of xml files is integrated in the database and included in the monthly fee
- the performance of saphŽus is excellent
- users work with saphŽus on a validated environment independent from hardware and software environment used on the user side
- PSURs and DSURs print-outs can be created according to GVP Module VII and CT-3 / E2F in a fast way
- the integrated multilingual MedDRAģ Browser supports users in coding of terms in a comfortable way
- the integrated Query Assistant supports users in creating queries without knowledge of SQL and data structure
- all parts of the development, testing, validation and data storage are located exclusively in Germany whereby the German law is affected
- users get personal support at any time from our helpdesk team that can be reached directly without computer based routing
- our professional pharmacovigilance services team provides support if required
- there are no special requirements regarding user's environment
- we support MS Windowsģ OS from Windows XP to Windows 8.1 Update 1
- no data will get lost in case the internet connection will be aborted
- the connection to saphŽus via the internet is safe and encrypted and additionally tunnelled by VPN

XEVMPD database -iris-
The database -iris- has been designed to capture the product data in accordance with article 57(2) of the EU regulation and to manage and to send them to XEVMPD. -iris- proves very valuable by much better and easier using, the possibility to manage the product data and to send the variations immediately if required without the need to enter the data again. Additional usable functions are available in -iris- like the simply to use multilingual MedDRAģ browser which enables to code indications faster and easier.
In addition -iris- can be characterised by the following properties:
- data collection and management of the entire XEVMPD data
- the possibility to create and submit the corresponding XEVPRM files by using the integrated Gateway
- import of XML files in XEVPRM format
- monitoring and listing of time periods to report variations
- interface for data exchange with our pharmacovigilance database saphŽus
- a user friendly copy function
- all parts of the development, testing, validation and data storage are located exclusively in Germany whereby the German law is affected
- users get personal support at any time from our helpdesk team that can be reached directly without computer based routing
- our professional pharmacovigilance services team provides support if required
- there are no special requirements regarding user's environment
- we support MS Windowsģ OS from Windows XP to Windows 8.1 Update 1
- no data will get lost in case the internet connection will be aborted
- the connection to -iris- via the internet is safe and encrypted and additionally tunnelled by VPN


Please do not hesitate to contact us in case of any questions or further information. (to contact page)

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