Formally develop scripts and test routines to verify the system is functioning as it should.
User Acceptance Testing
Ensure the software can handle required tasks in real-world scenarios.
Make certain you are compliant and stable through every upgrade.
Ensure that the development of all your processes are well-documented, traceable to a specific originator, and have an associated audit history.
Accept required electronic signatures in multiple areas of DEACOM to ensure compliance with the FDA requirements.
Allow for quality procedures to be monitored and controlled.
Formally define how all elements of your system are supposed to work, then develop scripts and test routines to validate it is functioning as it should.
Document all of your processes and procedures, make sure they are traceable, and ensure they have a historical audit. This audit trail history should be automatically generated and should not be modifiable.
Require a unique login and password for every user.
Ensure users have the necessary training to perform their assigned tasks and projects.
Establish quick and simple ways to locate records.
Allow for quality procedures to be monitored and controlled by ensuring documents are reviewed by specified individuals and they meet certain requirements before they are signed off.
“A digital signature is an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.” (FDA CFR Part 11)
DEACOM ERP software’s reports can be configured and used to verify compliance with these necessary regulations.
DEACOM ERP software supports the audit trail, database-level security, and application-level security required to pass audits.
DEACOM ERP software's electronic signatures comply with the FDA’s 21 CFR 11 requirements.