21 CFR part 11 regulations focus on electronic records and electronic signatures. The regulation includes directives to allow companies to replace paper records with electronic records and handwritten signatures with electronic signatures. These signatures must be treated as the equivalent to hand written signatures i.e. legally binding and irrefutable. To meet this requirement it is necessary to to ensure that a user's access to the system is appropriately controlled so that their actions (data manipulation, electronic signing etc.) can be linked to the user.
To aide customers with 21 CFR compliance, Riffyn processes and experiments are continuously audited and can be locked/unlocked based on a required number of signatures.
Riffyn’s current 21 CFR offerings include:
- Signing of processs and experiment using an electronic signature
- Locking/unlocking of experiments and processes
- Auditing of all actions taken upon an experiment or process
Future offerings will include:
- Data auditing
- Data export
- Data retention