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.

 

Learn More

*
Required

Invalid Input

*
Invalid

*
Please enter a valid business email address

*
Required

Not a Robot
Invalid Input

 

What Our Clients Say

  • KOMpliance provides us with functionality that wasn’t available before. We no longer have to worry about meeting different regulatory requirements for different types of studies or patients.

  • 1
  • 2
  • 3
  • 4
  • 5