FDA 21 CFR Part 11
The KOMpliance secure storage software solution enables organizations to meet FDA requirements for ensuring that electronic records and electronic signatures are trustworthy, reliable and equivalent substitutes for paper records and traditional handwritten signatures.
KOMpliance automatically retains records for the periods specified. During their retention period records are protected from any modifications, loss, or corruption from both internal and external sources. Audit trails allow verification that files have not been modified.