Authentic Electronic Records
21 CFR Part 11 requires assurance of the authenticity of electronic records. To maintain compliance, quality staff need a system that includes functionality to delineate user permissions for every document in the vault system.
Computer System Validation
The FDA requires any electronic system used to manage compliance-oriented documents and processes to be validated. Automating your data and quality processes with a digital solution will make it easier to validate your system.
Effective Change Control Management
Document controls must provide revision controls, change controls and time-based system modifications. An effective electronic system can automate these integral processes.