Validation
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.
Updating Ease
Make certain you are compliant and stable through every upgrade.
Why is 21 CFR Part 11 important for my company?
DEACOM is a highly-flexible enterprise resource planning system which enables individual customers to use the same functionality for entirely different business processes. Therefore, it is essential to validate a company’s mission-critical business processes with its own data prior to updating the ERP software in order to mitigate any risks. Although updating does require our customers to invest some time and effort into testing the validated system, Deacom has worked hard to create strategies that ensure it is done as seamless and efficient as possible.
Audit Trails
Ensure that the development of all your processes are well-documented, traceable to a specific originator, and have an associated audit history.
Digital Signatures
Accept required electronic signatures in multiple areas of DEACOM to ensure compliance with the FDA requirements.
Operational Controls
Allow for quality procedures to be monitored and controlled.
How to address 21 CFR Part 11
Validation
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.
- Verify the security of your data and audit logs.
- Increase the integrity of your record keeping.
Audit Trails
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.
Security Controls
Require a unique login and password for every user.
- Final records should be set with read-only permissions.
Training
Ensure users have the necessary training to perform their assigned tasks and projects.
Record Generation
Establish quick and simple ways to locate records.
- Document changes and iterations along with any necessary signatures/approvals that those changes are subject to.
Operational Controls
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.
- Easily examine and understand these procedures.
Digital Signatures
“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)
- Give an administrator complete visibility and control over the use of these signatures across the system.
- Provide a means to create and cancel signature requests as well as set the locations where signatures can be used to guard against fraud.
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.
