Source data containing critical information relating to compliance must be reliable and authentic.

Regulatory Regulations

Closed system is an environment where system access is controlled by the persons responsible for the content of electronic records on the system, the system design and development enforces steps and events in a workflow manner, ensuring accurate and efficient audit trails and compliance, organizations with tailor-made operational processes and unique internal regulations need to find own ways of ensuring regulatory compliance.

Want to check how your Title 21 CFR Part 11 Processes are performing? You don’t know what you don’t know. Find out with our Title 21 CFR Part 11 Self Assessment Toolkit: