SMB Validation

Technical solutions may take sometime to implement, what is FDA position on timelines?

There is no fixed date for complete remediation. The Agency had stated often that they would take enforcement discretion if an organization takes the appropriate steps to put a plan in place that addresses what systems need to be compliant and what the firm will do to get the systems there. These plans must include all applicable systems, be detailed and have reasonable timelines and hold persons responsible for implementing those plans. Check out the FDA's "Enforcement Policy: Electronic Records; Electronic Signatures-Compliance Policy Guide; Guidance for FDA Personnel" from 1999 ( if you want more information on enforcement.