FotoFinder xpert: Compliance
The use of computer systems for clinical studies is highly regulated by the respective approval authorities. The FDA (Food and Drug Administration) in the USA has set up certain requirements for electronic data recording and published them in directive 21 CFR Part 11. FotoFinder xpert clinical trial meets the technical requirements of this directive and therefore the standards of the FDA.
The FotoFinder user administration is tailored to the needs of your study. This means that users and user groups can be administrated and an individual profile to each user can be assigned. You define which functions and modules may be used by each single user and which personal user interfaces and authorizations are created. This way, user-errors are eliminated right from the start.
An important requirement of 21 CFR Part 11 is the Audit Trail function. FotoFinder xpert clinical trial is based on a powerful SQL server technology which means that your database is time-stamped audit trailed and each image can be proofed for authenticity. Therefore every single work step can be related to the user at any time.
This gives your study more transparency, e.g. concerning altered or deleted data.
To verify each user it is possible to use electronic signing, so that it is not possible to store, delete or falsify data under with an incorrect user name.
This function makes it possible to export images and data on CD and send encrypted data to the sponsor. This means that all study data can be compiled for revision at the headquarters. Data encryption gives maximum security and protects unauthorized data access.
Moreover, data can be transformed in PDF format and copies can be sent to the FDA for inspection.