Technical aspects
E-Records
Not all your electronic records are generated with a Part 11 compliant system and Part 11 compliant solutions may not always exist for certain specific systems...
...or instruments. Vialis helps you to manage all your electronic records in a Part 11 compliant manner, introducing version control, audit trails and record protection for all your e-records, just like §11.10 of 21 CFR Part 11 requires.
E-Signatures
Vialis helps you in identifying when and where you need to execute electronic signatures in your systems. In addition, Vialis will also help you in setting up controls...
...and policies for your identification codes and passwords, from simple electronic signatures with username and password up to biometric devices that fit your needs.
Easier upgrades
When implementing a new LIMS or CDS you need to make sure that you do not complicate future upgrades to newer versions. Vialis will help you in identifying the best way...
...to adapt your system to your work-flows while reducing the amount of customization that complicates upgrades and release changes and makes validation more difficult and time-consuming.
Interfacing solutions, Part 11 compliant and validated
Vialis expertise makes interfacing to instruments and other systems an easy task, even in a regulated environment. Vialis implements and validates your interfaces using well established and proven methods.