There is no silver-bullet soliton to complying with Title 21 CFR Part 11, and other FDA or international regulations on electronic records and e-signatures. Companies with tailor-made operational processes and unique internal regulations need to find their own ways of ensuring regulatory compliance.
This Validation Kit can significantly reduce the time and effort necessary to validate your computer system maintaining electronic records. While the Kit may need some customization to your specific needs and processes, it provides a great starting point and can save you immense costs in terms of internal resources and man hours.
In the handling of electronic records, FDA has a very narrow description of cases where Part 11 applies. As per the regulation, the system supporting e-records needs to be validated, audit trails have to be created, record retention managed, and record copying rules need to be defined.